Updated: What ever happened to the idea - "A Penny Saved is A Penny Earned"?

Maggie Mahar at The Health Care Blog digests the question presented by Dr. Atul Gawande in The New Yorker on December 10, 2007.
[Maggie's original post, which I missed, can be found at HealthBeat.]

Pilots Use Checklists. Doctors Don't. Why not?? by Maggie Mahar

Gawande may be too polite to say this, but the answer seems to me clear. There is no profit to be made on a checklist. What do you sell? Any experienced intensive care specialist knows what should be on the list. All anyone needs is a few pieces of paper and a pencil. Pronovost has invented a process for delivering health care—not a new hi-tech procedure, not a new product. And like Jonas Salk, who invented the polio vaccine, he is willing to give his idea away for free.

If there were something to sell, Johnson & Johnson or Genentech would have turned Pronovost and his idea into a new medical breakthrough long ago. The story would be reported in U.S.A. Today, trumpeted on the Evening News, splashed on billboards across the nation. Hospitals would be spending millions on ads bragging that they had this new breakthrough product: “At Mount Hope, Where We Care About Your Safety…”

In our for-profit healthcare system, people become truly excited about an idea when someone sees way to make a fortune. So Merck’s new vaccine, Gardasil, that protects against 70 percent of the viruses that cause cervical cancer has gotten extended play in the press, on TV, and on Wall Street. Meanwhile, the Pap Smear—a test that detects virtually all cases of cervical cancer and has, in fact, made this type of cancer a “rare disease” in the U.S., gets little notice. No national campaign to make sure every woman gets annual Pap Smears. It’s not a high-profit procedure.

In the U.S. the idea that the point of healthcare is better health seems to have been lost in the rush to make money. As Harvard’s Dr. Arnold Relman wrote in the most recent issue
of JAMA, ours is “the only health system in the world” where “investors and business considerations play such an important role. In no other country are the organizations that provide medical care so driven by income and profit-generating considerations.”

After following the developments of the small biotech company, Questcor Pharmaceuticals, Inc. which has sought FDA approval of H.P. Acthar Gel for the indication of Infantile Spasm, I definitely see the obscene importance placed on squeezing as much profit from a product as possible in the eyes of investors and executives.

Acthar is a 55-year old drug indicated for use in treating multiple sclerosis exacerbations. However, using its orphan drug status for Infantile Spasm, Questcor raised the price 15-fold from $1650 per vial to $23,265 per vial in August. Only in the U.S. does it seem a company can get away with such greed and price-gouging.

I recommend that you go over to The Health Care Blog and read Maggie's full post. I think that it just may change the way folks view improving processes in medicine which will ultimately save lives and save money.

UPDATE: Checklists Update--Administration Stops Program (via HealthBeat)

Today (Sunday, Dec. 30) the New York Times published a shocking op-ed by Dr. Atul Gawande revealing that a U.S. government agency has stopped an enormously successful "checklist" program that was being used to reduce infections in intensive care units at Johns Hopkins and throughout the state of Michigan.

Below, an excerpt from today's op-ed:
" In Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.

"A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. . .

"The results were stunning. . . . Over 18 months, the program saved more than 1,500 lives and nearly $200 million

"Yet this past month, the Office for Human Research Protections shut the program down. . .

"The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations," Gawande explains. "Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

"The government’s decision was bizarre and dangerous," he adds. "But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.

[However] "Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger.

"If the government’s ruling were applied more widely," Gawande notes, "whole swaths of critical work to ensure safe and effective care would either halt or shrink: efforts by the Centers for Disease Control and Prevention to examine responses to outbreaks of infectious disease . . .

"Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. . . . The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to," Gawande concludes.

Maggie asks, WHAT IS GOING ON HERE?

I agree with her doubt that the decision had anything to do with medical ethics or patients' rights. Perhaps, someone was worried that the checklist program would draw too much attention to just how prone to error our healthcare system is. Maggie plans to try to find out more about what motivated this decision, who runs the agency in question, etc. and welcomes your ideas. You may e-mail her confidentially at mahar@tcf.org.

Twenty-one (21) years ago my younger brother was in the Intensive Care Unit for two weeks after having been runover. He had moments that were dangerously close to death, but was most afraid of sleeping at night. Since he was on a ventilator and could not speak, we resorted to mouthing words, gesturing a little, and writing notes. For the first time in our lives, we were able to communicate clearly and understood each other.

During the night shift he was most afraid because when a particular nurse was on duty, it took just a little too much time to response to problems with the machines he was hooked up to. He had moments where breathing stopped and he was powerless to do anything about it but to press the alarm button and wait for help.

My parents and I would tear those notes out of the notepad so that other nurses would not see his fear and anger. Looking back, I think we tried to keep from rocking the boat too much and should have asked more questions. As it was, I was only 18, my brother was 14, and my parents were younger than I am now at 36 years of age.

We didn't fully understand exactly how close to death my brother was at the time and how unbelievably fortunate he was as his injuries most resembled the type one would experience being crushed against a steering wheel in a major car accident.

Errors or no errors. Hospitals and nurses must not be afraid to examine their processes and the care they provide. Doctors must not be afraid of following simple steps to ensure the best care for their patients. And patients and parents should not be afraid of questioning the care they receive especially when they are most vulnerable in the I.C.U.

3 New Year's Resolutions which Everybody Can Keep

It's that time again...

New Year's Resolutions and Doomed Attempts at Changing Your Life

But resolutions do not need to be grand and unattainable. Over at Disaboom, Vicki of Vicki's MS Path has an excellent post addressing some simple goals which everyone can accomplish year round.

Ask for Help * Smile * Don't Give Up - Make Today a Great Day

Maybe the best one -- the one we can all do -- is to resolve to make each day the best day possible. This is very personal, whether it means to try to get a step closer to achieving a special goal, to add a smile to someone else's day (and thereby smiling ourselves), or simply just making it through the day. Every day has the potential for being a great day. We have to approach it with the right attitude and be delighted even with small accomplishments.

That's a good beginning for this 2008.

Will I keep my resolutions? This is the hard part. Studies have determined that 63% of resolvers keep their resolutions for at least two months, but only 15% keep them for over a year. Another study reminds us it takes 21 days to make something a habit and six weeks to actually make it part of our personality.

If you slip, try again tomorrow. One slip doesn't mean it's over. [...] Give your resolutions a chance, after all, you made the resolution. If it's just impossible, remember January 17 is Ditch New Year's Resolutions Day.

Thanks Vicki for some inspirational thoughts.

Happiness, Peace, and Healthcare Reform

Upon reflection during this final week of 2007, I recognize some revelations in my life.

1. I am happy.

This was the first Christmas in several years that did not accompany sadness, anger, fear, or grief in my life.

• 2006 - Due to (yet undiagnosed) Rheumatoid Arthritis, I could not straighten my fingers, had no grip strength, and often felt as though I had placed a finger in an electrical outlet. Gentle pressing on anything as benign as piano keys, computer keyboard, or french horn levers caused severe pain, as did holding a pencil or silverware. Carpal Tunnel Syndrome was diagnosed and surgery was discussed with the Hand Surgeon. There were times that I said I simply wanted my arms chopped off as I fantasized that would make the pain go away. Very low times for a professional musician!
  
• 2005 - I had finally been diagnosed with Multiple Sclerosis in October, had begun disease-modifying treatment in December, and was working on another relapse requiring IV steroids in January. In June, I was experiencing tingling, numbness, and pain in my left hand which slowly spread up my arm and over my shoulder blade. My doctor ordered a MRI and then referred me to a neurologist who wanted another MRI in July (this time with contrast.) However tests were not conclusive yet, so a spinal tap was done after which I was called into the infusion center for IV steroids in August. Although I had had optic neuritis in 2000 and a variety of odd health complaints since then, an MS diagnosis still could not yet be made official. After a follow-up MRI in late September, it began official.
  I have Multiple Sclerosis!
  
• 2004 - I was experiencing what I now believe to be a mild MS relapse which kept me from participating in some fun social activities. Blah.
  
• 2003 - Much family turmoil after my grandmother died and my parents were in the midst of a divorce after 35 years of marriage. Mountains of Tears that year.
  
• 2002 - Actually a pretty good Christmas. My brother brought his family out to Virginia for only the 2nd time in the 10 years our mother has lived outside DC. However, tensions were high for reasons I didn't understand at the time but which I do now.
  
• 2001 - I live outside Washington, D.C. Enough said.
  
• 2000 - I was just beginning to feel better after the optic neuritis and subsequent high-dose oral prednisone regimen which likely did delay further development of MS for awhile. I was not well for a majority of that year.

2. I am grateful.

• 2007 - This year was tough for me with the idea of hand surgery looming and all the accompanying fears of never being able to play piano again. However with the swift determination of a fabulous rheumatologist, my arthritis is mostly contained. I still experience inflammation and pain, but it is minor compared to just one year ago and I am thrilled. I also finally figured out the requisite income level necessary to receive a 100% award from NORD to cover my MS drug. That provided huge financial relief, if only for one year.

3. I am loved.

• 2005/2007 - I met Rob just one week before that first appointment in May '05 with my primary doctor during which I mentioned the tingling in my fingers. Rob has stayed by my side through the MS diagnosis, through the IV steriods, through all the crying, through all the anger, through all the pain and disabling RA, through all the fear, and even through the 'attempts' to 'walk on air right off the sidewalk' (which isn't very effective I must say.)

The peace I feel now is allowing me to discuss issues surrounding some of the absurdities in our American healthcare system.

For two days this week, I could not straighten my legs. First my calves were so tight and knotted that I seemed to be walking on my toes and probably resembled the fabled Pan. After working on those muscles to let go so that I could use my ankles, my hamstrings and calves pulled their hardest so that my knees couldn't straighten. So I tried hard to stretch those muscles and make them relax and guess what? the tension moved to my gluts and lower back.

I honestly don't know if this was an episode of spasticity or a mild MS relapse or what. But it got me thinking...

In the current health reform debate, each facet of the business of providing healthcare to consumers (I actually prefer the term patient) is busy pulling toward their own argument. Each facet (doctors, hospitals, nurses, insurance companies, managed care organizations, disease management, pharmacy benefit managers, non-profit organizations (political and disease-oriented), hedgefund investors, capital investors, stockbrokers, individual stockplayers, pharmaceutical companies, lobby groups, grassroots organizers, researchers, journal publishers, advertising agencies, consultants, lawyers, government agencies, whitehouse officials, congress, and yes even patients) uses data for their own purposes. Each facet focuses on their own ideals without consideration of others' views. Each facet selfishly wants what seems personally most advantageous.

Just as each of my leg muscles wanted to pull in its own direction without regard to the adjacent muscles and physical structures, those identities debating and determining healthcare reform are not honestly considering the needs of the whole person (or system.) My calves didn't seem to care much that I needed them to let go some of their power to allow me to walk comfortably. My gluts didn't care too much that the harder they pulled the more my lower back would cryout in pain.

We, as a society, cannot pull so hard toward our own interests and risk sacrificing the flexible function of the whole. I guess my view on healthcare reform is a holistic one. Not holisitic as in homeopathy, but holistic as in most advantageous to all facets of the 'industry.'

Americans in general are greedy. When it comes to providing the best services, and ensuring the most reasonable outcomes in healthcare, we need to set greed aside and work together to address the needs of every entity involved.

Somebody needs to give up a little power in order for reform to move forward in any reasonable manner, just as my leg muscles had to 'let go' so that I could walk up and down the stairs today to do my laundry.

So there. That's it. My current take on the healthcare reform debate. Somethings gotta give or we will get stuck immobile and impotent.

Announcing the new 'Carnival of MS Bloggers' in 2008

Announcing a new watering hole for those with Multiple Sclerosis and those who write about Multiple Sclerosis --

Carnival of MS Bloggers

"A gathering of MS Bloggers sharing thoughts, opinions, news, and inspiration around the Blogosphere."

The Carnival will be hosted by Lisa Emrich at Brass and Ivory. If you are interested in hosting future Carnivals, please contact Lisa.

You may submit articles using the form at Blog Carnival or by email.

Please include the following:

• Your blog's URL
• Your post's URL
• The post's permalink URL (if available)
• A brief summary of the post
• Category - Inspiration, Life, MS News, Multiple Sclerosis, Opinion

Submission Deadline - Noon on the 1st and 3rd Tuesday of every month

2008 Blogger's Choice Awards!!

Brass and Ivory has been nominated for the 2008 Blogger's Choice Awards!

Vote 'Brass and Ivory' for Best Health Blog!!

Vote 'Brass and Ivory' for Best Political Blog!!

Your votes and support is greatly appreciated.

Thanks in advance.

Is Pfizer guilty of being a "Constant Gardener" in Nigeria?

The WSJ Health Blog discusses details of Nigeria's legal case against Pfizer.
AP reports:

The now-controversial trials for the antibiotic Trovan [by Pfizer] were conducted in Kano [Nigeria] on 200 children during a meningitis epidemic in 1996. Nigeria alleges Pfizer conducted the trials illegally, without the full knowledge and consent of the government and the parents, causing the death of 11 children and injury to dozens of others.
A message left with Pfizer headquarters in New York was not immediately returned Tuesday, but Pfizer has always denied any wrongdoing, insisting the drug saved lives.

Nigeria's Kano state and the federal government have instituted separate civil and criminal cases against Pfizer. The federal authorities demand $7 billion in damages.

Judge Atiku, who is presiding over the civil case in Kano, postponed further hearing to Jan. 29, 2008.

The Health Blog concludes:

The cases are an extreme example of the ongoing tensions between multinational drug companies and the developing world, and some industry-watchers are waiting to see whether other developing countries follow with their own legal actions.

While I don't agree with opaque tactics which the 'big pharma' drug industry may employ to justify spurious testing, I do find myself appreciating one comment left on the Health Blog by "An Observing Pharmacist."

The kids who received Trovan (taken as a pill) did just as well as the kids who took an IV antibiotic. Pills are easier to distribute and administer than an IV, so the hope was to treat more kids and people effectively.

Nigeria is reaching into the deep pocket [of Pfizer] hoping to pull out some cash.

Testing methods of delivery of a particular pharmaceutical is at the heart of 'evidence-based medicine' where assumptions must only be made in creating a hypothesis to be scientifically proven or disproven.

Last year a trial conducted as part of the search for an effective oral formulation of an existing MS disease-modifying drug failed miserably. There was hope that an oral pill would become available for MS sufferers who are currently only offered self-injectible or IV delivered drugs to curb the progression of the disease. Once an effective oral drug is available, the blockbuster status of current MS drugs will diminish dramatically as will the pharmacy costs to the patient and their insurance companies.

I don't know if Pfizer is guilty of misbehavior in this case. I certainly hope not. But it does appear that Nigeria is looking to reap some considerable financial benefits at the ultimate expense of the number of patients who must pay for the resultant increased costs of current and future Pfizer medications.

It's unfortunate that the government of Nigeria is looking to the American model of 'sue, sue, sue' to punish Pfizer for being their "Constant Gardener."

Hugh Downs helping to Hawk Alternative Medicine 'Secrets'

Everyone is trying to grab your dollars. Often this is done by hyping a desperate need for something unique -- information, product, service, etc. -- and creating a sense of urgency in obtaining what's being offered.

After watching Face the Nation this morning, I was assaulted by an infomercial hawking a newly expanded, 'must have' book of the season.

The World's Greatest Treasury of Health Secrets

"Drug industry doesn't want you to know about...."

"It's true -- warts can be cured by ducktape."

"buy one for yourself and more for your loved ones"

So that's it...buy, buy, buy...spend YOUR money for a collection of articles, for secrets that "THEY" don't want you to know, for 'cures' to common chronic illnesses.

Are we to infer that the 'big money medicine' and 'big pharma' industries really want us all to stay ill and unhealthy so that "THEY" can make huge profits off of our illnesses?

Well, there may be some truth to that...but let's get real.

I am confident that my doctors sincerely wish the best for my health and wellbeing. The idea of 'secrets' is offensive and questions the role of 'evidence-based' medicine in our medical/healthcare system.

I wonder if the ingestion of colloidal silver is included in the Treasury. If so, I would question the validity of the entire collection.

The Treasury is over 545 pages and touts the expertise of over 450 experts. Seems to me that each contributor did not receive much print space. How detailed can one get being limited to one page of information?

Below are some details taken from their website:

The world's greatest traditional and alternative doctors join forces at last... and their findings could extend your life by 40 happy, healthy years.

Over 500 pages of secrets including:

• The little-known heart attack symptom that so many people tragically ignore (often you feel no pain at all)...
• Grow your own army of cholesterol-cutting microbes in your gut. These friendly bacteria normally help us digest our food and keep our cholesterol down. Discover the little-known nutrient that restores them to healthy levels.
• The common pain pill that secretly raises your blood pressure. It's a side effect that drug manufacturers hate to talk about, because they make so much money from this remedy. But if you substitute an equally effective pill, your pressure may normalize all by itself.
• Double your immunity to colds. Echinacea... Vitamin C... Zinc... You've tried them all, and they don't work, do they? But our team found this to be foolproof.
• Reverse brain drain. Neurologists call this breakthrough "arborization." It makes your neurons secrete new growth hormones, reactivating your brain. And you can do it yourself in just 20 minutes a day!
• The eating cure for arthritis now proven in 15 different studies. Scientists have long known that some foods reduce inflammation. Others make it worse. This amazingly effective program simply increases the helpful type and dials the others down. Doesn't cost you anything!
• Did you know that breast cancer patients who don't meekly obey doctor's orders are twice as likely to be alive 15 years later? See the surprising reason why.
• The powerful natural powder that stops most prostate tumors from spreading. Totally safe!
• Switch migraines off with simple 3-vitamin formula.

And much, much more!

Over 450 experts, including:

DAVID ALBERTS, MD, Arizona Cancer Center, Tucson
ANN M. ARVIN, MD, Stanford University School of Medicine, CA
JOHN BARON, MD, Dartmouth Medical School, Hanover, NH
HERBERT BENSON, MD, Harvard Medical School, Cambridge, MA
KEITH BLOCK, MD, The Cancer Institute Edgewater Medical Center, Chicago
JEFFREY BLUMBERG, PhD, chief, Antioxidants Research Lab, Tufts University, Boston
DR. JOYCE BROTHERS, renowned psychologist and best-selling author
THOMAS BROTT, MD, professor of neurology, Mayo Clinic, Jacksonville, FL
DEEPAK CHOPRA, MD, founder, Chopra Center, Carlsbad, CA
JOAN BORYSENKO, PhD, New England Deaconess Hospital, Boston, MA
RACHELLE DOODY, MD, PhD, director, Alzheimer's Disease Research Center, Baylor College of Medicine, Texas
PETER D. FRY, MD, University of British Columbia, Vancouver, Canada
JOE D. GOLDSTRICH, MD, former medical director, Pritikin Longevity Center; author, Healthy Heart, Longer Life
WILLIAM B. GRANT, PhD, senior research scientist, NASA
JAMES GORDON, MD, Georgetown Medical School, Washington, DC
JUAN C. GUARDERAS, MD, Mayo Clinic, Jacksonville, FL
STEVEN F. HOROWITZ, MD, Stamford Hospital, CT
HENRY D. JANOWITZ, MD, Mount Sinai School of Medicine, NY
DANIEL LEVY, MD, director, Framingham Heart Study, Framingham, MA
CHRISTOPHER LINSTROM, MD, chief of otology, New York Eye and Ear Infirmary
BERNARD LOWN, MD, professor emeritus, Harvard University School of Public Health, MA
NORMAN MARCUS, MD, Norman Marcus Pain Institute, NY
JOHN MCDOUGALL, MD, director, McDougall Program for controlling heart disease
SAMUEL MEYERS, MD, Mount Sinai School of Medicine, NY
RANDOLPH M. NESSE, MD, University of Michigan Medical School, Ann Arbor
MICHAEL J. NORDEN, MD, clinical associate professor of psychiatry, University of Washington; author, Beyond Prozac
THOMAS PICKERING, MD, Mount Sinai Hospital, NY
SHELDON PINNELL, MD, professor, division of dermatology, Duke University, NC
DAVID S. PISETSKY, MD, Duke University Medical Center, NC
STEVEN PIVER, MD, director and founder, The Gilda Radner Familial Ovarian Cancer Registry
BANDARU S. REDDY, PhD, chief, Division of Nutritional Carcinogenesis, American Health Foundation, NY
RICHARD M. RESTAK, MD, clinical professor, George Washington University School of Medicine, Washington, DC; author, The New Brain
PERRY ROBINS, MD, New York University Medical Center
KENNETH ROTHAUS, MD, Cornell University Medical College, NY; coauthor, Hospital Smarts
ROBIN I. RUSSELL, MD, PhD, chief of gastroenterology, Glasgow Royal Infirmary, Scotland
BARRY SEARS, PhD, author of The Zone, former scientist at the Massachusetts Institute of Technology
HARVEY B. SIMON, MD, Massachusetts General Hospital, Boston
MARGARET A. CAUDILL-SLOSBERG, MD, PhD, MPH, instructor of medicine, Dartmouth Medical School, Hanover, NH
JAMISON STARBUCK, ND, University of Montana, Missoula
JASON THEODOSAKIS, MD, University of Arizona College of Medicine, Tucson
JUDITH WURTMAN, PhD, research scientist, Massachusetts Institute of Technology; author, Managing Your Mind & Mood Through Food

Merry Christmas -- Straight No Chaser

Hope you enjoy this little diddy from some great sounding guys from Indiana University.

'Straight No Chaser' formed in 1996, just a little before I moved to DC in 1998.

Enjoy. 'Tis some awesome men's acapella.

Merry Christmas and Happy New Year!!

Sooners vs. Hokies - BCS Rejects the Request for Matchup

Immediately following the championship games at the first of December, I posted the bowl game matchups of the two college teams most important in this household.

Lisa - Sooner '90 and Rob - Hokie '91

Well a fellow Sooner (who happens to be a doctor) sent me a note asking if I knew that a request had been made (and rejected) to pair the Oklahoma Sooners with the Virginia Tech Hokies at the Orange Bowl this year. I was not aware of the story yet (too much preparation for Christmas I suppose.)

Stewart Mandel of Sports Illustrated wrote a neat little piece...

The Orange Bowl that Wasn't

Proposed Oklahoma-Va. Tech Game Busted by BCS

The BCS selected Ohio State (1) and LSU (2) to play in the BCS National Championship Bowl. None of the other highly ranked contenders (Oklahoma, Georgia, Virginia Tech or USC) will be pitted against each other in bowl games.

However, an agreement had been made which would have allowed Oklahoma (3) to play Virginia Tech (4) in the Orange Bowl. But the BCS conference commissioners shot down the idea.

According to the official BCS selection process, the Hokies, as ACC champions, and the Sooners, as Big 12 champions, were "contractually committed" to their conference's host games -- Virginia Tech to the Orange Bowl and Oklahoma to the Fiesta Bowl.

However, there's also a written clause -- one that has yet to be invoked during the BCS' 10-year history -- that allows the commissioners to "adjust the pairings ... after the completion of the selection process." Among the circumstances that can be taken into consideration are "whether the same team will be playing in the same bowl game for two consecutive years" (Oklahoma played Boise State in last year's Fiesta Bowl) and "whether alternative pairings may have greater or lesser appeal to college football fans ..."

Hey -- Sooners vs. Hokies would have been a GREAT GAME!!!

"If we weren't going to be in the 1 vs. 2 game, we wanted to know if there was a possibility to play the highest-ranked team out there," said Oklahoma AD Joe Castiglione. "At that point, we didn't know which team that would be."

Proposed adjustments to the written placement rules must be requested and then approved by the BCS commissioners following the conclusion of the formal selection process. Big 12 commissioner Dan Beebe said he made the request on behalf of his league's school but was met by resistance.

When asked why the opportunity to see the No. 3 and 4 teams play would not qualify as a game with "greater appeal to college football fans," as the BCS manual spells out, SEC commissioner and current BCS coordinator Mike Slive replied, "Everybody looked at that, and knowing that, still came to the same conclusion. In any such consideration of something like this, you have to look at the question of what precedent does it set -- particularly when there have been more compelling requests that have not been granted -- and what are the unintended consequences?"

And what unintended consequences are those? Possible split national championship titles if Oklahoma won by a landslide?

Oklahoma AD Joe Castiglione commented, "I just hope at some point in time we can hear an explanation of why this wasn't possible given the fact the rules provided that opportunity if it was in everybody's best interest. Clear-thinking, well-intentioned minds would like to know whether something like this is possible."

Fair enough question. Personally, I still think it would have been a great matchup. For more, read "The Orange Bowl that Wasn't."






Virginia Tech won the ACC Championship over Boston College and are headed to the 74th Annual FedEx Orange Bowl. The Hokies will face the Kansas Jayhawks on January 3, 2008 in Miami and tickets go on sale early this week.







University of Oklahoma won the Big 12 Championship over Missouri and are headed to the Tostitos Fiesta Bowl. The Sooners are the first team in Big 12 history to win consecutive titles and will face West Virginia on January 2, 2008 in Glendale, Arizona.



It will be an exciting football Bowl Season.

Go Sooners! Go Hokies!

Health Plan Lobbyists suggest States 'Guarantee Access' to Potentionally High-Cost Individuals

The New York Times reports (via Health Blog) that the America's Health Insurance Plans (AHIP), the industry's trade association and lobbying force, wants to help individuals with pre-existing medical conditions find health insurance coverage.

The AHIP proposal is titled 'Guaranteeing Access to Coverage for All Americans.' Highlights of the proposal include:

• States should create Guarantee Access Plans to provide coverage for uninsured individuals with the highest expected medical claims costs (greater than 200% or twice the statewide average.) Premiums would be limited to 150% standard market rates.
• Health plans will guarantee coverage to all applicants who are not eligible for the Guarantee Access Plan....up to a predetermined level of participation (for example, 0.5% of the health plan’s insured population in the individual market). Premiums would still be limited to 150% standard market rates.
• Health plans should limit any rescission actions to those based only on information that should have been included in a complete and accurate response to questions asked in a clear and understandable application. [Got that? If the questions are clear and understandable, rescission actions are still an option.]
• Health plans should waive the application of pre-existing condition exclusions for medical conditions that are disclosed by the applicant (unless subject to a rider). [So if coverage is subject to a policy rider, the pre-existing condition exclusions stand.]
• States should provide consumers with access to a third-party review process to resolve disputes involving medical issues related to pre-existing condition exclusions and rescission decisions. [We don't want to be bombarded with disputes to resolve. Let the state take care of that.]

“We are taking responsibility for ensuring that no one falls through the cracks,” said Karen Ignagni, CEO of AHIP, which is based in Washington. “We are providing essentially a coverage safety net,” she said.

Within the proposal, it is recommended that in order the maintain affordability, states will need to:

• Allow health plans to offer features such as:

Pharmacy programs that promote both value and safety [American produced generics];

Disease management, preventive, and care coordination programs that bring evidence-based care into everyday practice [lots of calls from DM folks who specialize in keeping costs down for the insurance company by discouraging costly ER visits and unnecessary trips to see the doctor]; and

New benefit design and payment incentives that reward quality and value [if you choose to use your coverage the way we want you to and see the practitioners we feel provide greater value, it might cost you less in out-of-pocket expenses].

• Create a sliding-scale premium subsidy program with additional assistance for those with high health care costs.
• Fund the Guarantee Access Plans from a broad base of sources, so that coverage remains affordable for those who are currently insured. [That's it states....go find the money while we take care of the less costly customers].

In the Times, the trade association declined to provide any estimates for the cost of its proposals. But executives argued that this approach was not so ambitious as to make it out of reach.

“It won’t break the bank,” said Mr. Gellert.

Whose bank won't it break?

With President Bush insisting that individuals must not be given incentives to leave private coverage and with disagreement as to what constitutes low-income, middle-class, and affordability, America's Health Insurance Plans wants to be viewed as the good guys while they provide the guidelines to justify their position in NOT PROVIDING COVERAGE TO THOSE EXPECTED TO BE MORE COSTLY TO COVER.

Unbelievable!!!

UPDATE: And if you don't believe me, go read what Dr. Wes has to say. Bravo!

Misguided Attempt at Influencing Patient and Political Behavior

So Kevin, M.D., applauds the great idea that physicians use big-screen TVs in their waiting rooms to warn and educate patients on the impending physician shortage, as well as educating the public on the malpractice crisis.

He refers to an article in The New York Sun -- "Captive Audience: MDs Fighting Back on Malpractice" by staff writer E.B.Solomont. So like any responsible reader, I followed the link to the original article.

Fed up with the state's medical malpractice insurance crisis, some New York City doctors are airing televised messages in their waiting rooms that warn patients of a looming physician shortage.

One 60-second spot describes a scarcity of radiologists in the Bronx who are willing to perform mammograms because liability costs are too high. The message aims to change the way patients think about malpractice, doctors said, adding that by airing the advertisements they aim to shore up legislative support, and to inform patients that higher insurance costs could mean they'll have to pay higher fees.

"I don't think it's going to keep anyone from suing, but I think
the public has to know where the health care dollars are going," a Manhattan internist, Dr. Margaret Lewin, said. "My objective is to educate the patient as to what's going on politically, so if they can join us in making some changes that would be terrific," Dr. Lewin, who is president of the New York County Medical Society, said.

So far, more than 100 offices in Manhattan and in the Bronx have been outfitted with $4,000, 40-inch television sets that were donated to members of New York's medical societies by a Long Island company, MedLink International. The company also sells products such as electronic health records.

Forget the idea of malpractice for just a moment. Why is a healthcare IT company donating large flat-screen TVs for use in physicians' waiting rooms?

On December 6, 2007, MedLink International, Inc. announced that the Bronx County Medical Society ("BCMS") has officially endorsed MedLink International and its products and services, including MedLink TV.

More than 800 physician members of BCMS will be offered MedLink TV as a benefit of membership with the New York County Medical Society.

BCMS members will receive the 40" flat-screen MedLink TV for free, as long as they are in good standing with the BCMS. Physicians can sign up for the service at http://www.medlinktv.com/, in addition to finding out more information about the program.

MedLink TV, a partnership between MedLink and DynaTek Media, in cooperation with industry leading physicians, strives to provide patients with thought-provoking, entertaining and informative healthcare related programming. Physician members of BCMS, by supporting MedLink TV and providing this programming in their waiting rooms, are encouraging thoughtful communication between patients and healthcare providers, with the goal of providing the very best in healthcare for their patients and their families.

This announcement followed on the coattails of the October 15, 2007 announcement in which the New York County Medical Society ("NYCMS") officially endorsed MedLink International's MedLink TV.

More than 8,000 physicians in Manhattan will be offered MedLink TV as a benefit of membership with the New York County Medical Society.

MedLink representatives recently met with NYCMS in September to discuss MedLink offerings that can be a benefit to the Society's members. After careful consideration, the Executive Committee of NYCMS voted to endorse MedLink TV.NYCMS members will receive the 40" flat-screen MedLink TV, a more than $5,000 value, for free as long as they are in good standing with the NYCMS. Physicians can sign up for the service at http://www.medlinktv.com/, in addition to finding out more information about the program.

On August 16, 2007, MedLink International, Inc. formally announced the signing of a consulting agreement with the leading healthcare law firm of Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato & Einiger.

The affiliation will be spearheaded by one of the firms Senior Partners, Scott Einiger, general counsel to The New York County Medical Society.

Medlink CEO Ray Vuono states “We have established this strategic alliance with the preeminent Healthcare Law firm in New York State, one that has a longstanding relationship with organized medicine, hospitals and nursing homes. We at MedLink are extremely pleased to have entered into this new relationship as we continue our efforts to bring our simple, secure and affordable electronic medical record and practice management solutions to the medical community nationwide.” said CEO of Medlink Ray Vuono.

Through his 20 years as a healthcare legal advocate, Mr. Einiger has worked extensively with medical societies associations, and organizations. In addition to Mr Einiger, Gary Gatza will be bringing his many years of experience to the relationship. Mr. Gatza has practiced law for over 25 years and prior to joining Abrams, Fensterman, he served as General Counsel and Executive Director of the New York County Medical Society.

Mr. Einiger stated “MedLink has expressed a true desire to partner with and support organized medicine while providing practicing physicians with the tools to succeed in an extremely competitive environment. MedLink’s cutting edge technology provides an extremely cost effective solution for the practicing physician. Health care consumers will also receive a tremendous benefit from MedLink TV, a healthcare network that provides relevant healthcare programming right in the physicians waiting area”.

Scott Einiger is senior partner and director of the New York City Health law practice at Abrams, Fensterman, Fensterman, Eisman, Greenberg, Formato, & Einiger, LLP. Mr. Einiger has extensive experience in healthcare law. A leader in his field, Mr. Einiger is Special Counsel to The New York County Medical Society and General Counsel to The American Academy of Psychoanalysis. He has recently been named counsel to the New York Society of Gastroenterology. He was also part of a comprehensive risk management/quality assurance program designed to reduce liability risks for health care professionals and hospitals insured with the Medical liability Mutual Insurance Company, where he was counsel for 15 years.

Abrams, Fensterman, et al. is one of the largest health care law practices in New York State representing their clients in a variety of complex health care related matters. "Our health care lawyers understand the demands of the market and have broad legal experience with a wide range of issues facing our valued clients."

Back to MedLinkTV where patients will be exposed to 60-second spots warning of the dangers in the rising malpractice crisis and the looming doom of physician shortages at least once during each half hour.

On March 21, 2007, MedLink International, Inc. announced that it...

...has expanded its relationship with DynaTek Media Corporation to form MedLinkTV, which will deliver content and advertising to a digital screen network in the waiting rooms of physician offices and outpatient clinics.

Ray Vuono, CEO of MedLink, stated that, "MedLink is very excited to provide patients with informative health care information through MedLinkTV LLC, which we have formed with DynaTek Media, our content delivery partner. DynaTek will provide and deliver entertaining health-based information and advertising from pharmaceutical companies and consumer product companies to the consumer while they wait for procedures and examinations."

Mr. Vuono continued, "MedLinkTV LLC offers advertisers a captive audience of viewers who can be reached through targeted messaging. Consumers will be in an environment where they will be receptive to hearing about health and wellness issues, and products that can enhance their wellbeing and lifestyles."

Ron Gross, CEO of DynaTek Media, Inc., added that, "DynaTek is looking forward to deploying MedLinkTV, which will ultimately be able to bring product information to consumers, ranging from prescription drugs to over the counter items, such as headache and allergy remedies, as well as informative content that promotes health and wellness. MedLink TV content will help make the patient experience during doctor and clinic visits a more positive one for consumers."

Now we're finally getting to the heart of the matter, the root of the problem, and the motivation behind the education being offered....product placement and advertising.

I went to the DynaTek Media website and watched some examples of their work. Their MedLinkTV demonstration certainly looked like a 'fake news' report accompanied by commercial advertising.

In the New York Sun article, public service announcements created from news broadcasts were mentioned.

"We want patients to begin to think about the potential in the future for them, that their physician may not be able to afford to be in practice," the president of the Medical Society of the State of New York, Dr. Robert Goldberg, said.

The doctor of osteopathic medicine said he has several colleagues who are no longer able to afford their insurance premiums. "This is very real," he said. "There are ramifications to the frequency and severity of these lawsuits," he said. "One of them is, will there be a doctor to take care of you?"

In one public service announcement, which was adapted from a news broadcast in Oregon, a woman is forced to drive several hours to see an obstetrician because of a shortage of doctors in her town.

Now you can ask me, but probably can already guess my opinion.

Did the Oregon news broadcast truly arise from relevant news in that particular locale or was it produced merely for it's future propaganda value?

2007 Medical Weblog Awards: Nominations are now being accepted

MedGadget is initiating the fourth annual Medical Weblog Awards.
You can nominate blogs in the following categories:

• Best Medical Weblog
• Best New Medical Weblog (established in 2007)
• Best Literary Medical Weblog
• Best Clinical Sciences Weblog
• Best Health Policies/Ethics Weblog
• Best Medical Technologies/Informatics Weblog
• Best Patient’s Blog

Nominations can be made in the comments section of the MedGadget post.

Blogosphere etiquette on these things is still evolving. But I would welcome reader support in the 'Best Patient's Blog' category.

Thanks.

Net Wish and Modest Needs -- Spreading Acts of Kindness

Two Organizations which are Making a Difference:




Founded in 2002, Modest Needs is an award-winning public charity with a simple but critical mission: we work to stop the cycle of poverty BEFORE it starts for the low-income workers whom conventional philanthropy has forgotten.

We do this by empowering compassionate members of the general public to safely and securely help hard-working, low-income households to afford the kinds of short-term emergency expenses that we've all encountered before: the unexpected car repair, the unanticipated visit to the doctor, or the unusually large heating bill, for example.

Since 2002, by working together in this very 'modest' way, Modest Needs' donors have stopped 4192 low-income individuals and families from entering the vicious cycle of poverty and a lifetime of dependence on the public welfare system for their survival.

And, in the process, with our 'small change,' we've freed up millions of dollars in state and federal funding that would've been used to support these people - our neighbors - had we turned our backs and done nothing to help them in their times of short term crisis.

Discover your power to instantly change a life. Please join your friends and neighbors in supporting Modest Needs.

Because Modest Needs has earned the highest possible charity rating from the Better Business Bureau's Wise Giving Alliance, you can give with confidence, knowing that we won't abuse your kindness.

But more importantly, together, we can make sure that no hard-working person is ever forced to choose between taking a child to the doctor and putting food on the table.

*************************************************************************

Net Wish.Org is not a traditional non-profit organization!


Net Wish.Org is the brain child of successful businessman who has set aside a moderate amount of money per Month to help those less fortunate.
The donor wishes to remain absolutely anonymous and receives no tax deduction for the donations - This is real charity.

Net Wish removes the red tape of traditional non-profit organizations and uses the power of the Internet to provide direct and immediate assistance to families and individuals who desperately require a modest helping hand.
Our specific focus is how the aid will benefit children, older adults and other vulnerable members of our community.

Request for wishes are reviewed and applicants who have a request
accepted may be contacted directly.

Again, the donor wishes to remain anonymous and all applicant
information and requests will remain strictly private.

Remember, the more specific the request the better chance of a helping hand.

We rely on the honesty of the applicants and fraudulent applications will take help away from people who honestly need it.

Net Wish.Org is where need and action meet.

Acts of Kindness All Around

Doing something unexpected for someone else can often make the day of both individuals involved. Truly a nice benefit of sharing a little kindness.

A few weeks ago, I stopped at a nearby gas station to fill-up the tank. There happened to be a young couple at the station asking for $1 (from separate individuals) to help pay for some gasoline. And it was apparent that the jaded folks in this area were blowing them off.

Their car had Pennsylvania tags and here we were in northern Virginia. They realized that they had severely underestimated their gas reserves and knew that an empty tank was imminent so they pulled off I-95.

Now, you may first think....what a scam....NO MONEY for GAS?
Come on now....credit cards anybody?

Well, I happen to remember the first credit card I applied for and that was when I was a 24-year old doctoral student. This couple looked to be about 18-19 years old and were obviously becoming concerned that they might not be able to purchase a meager 3-4 gallons of gas to get them to his father's home in rural Pennsylvania.

Again, you may think....what were they doing hitting the road without any cash?

Sometimes people without much life experience simply don't plan for the unexpected. Years ago, I had a friend who was driving across country from Indiana to his family's home in San Marino, CA. Now this was a guy who came from money. The backyard of his family's home butted the Huntington Library and Botanical Gardens, a beautiful location. After stopping for a visit in Oklahoma City, he was going to hit the road again with $7 in his wallet.

$7 total to take him the rest of the way!!! What was he thinking?
Well, sometimes youth doesn't think and my parents gave him some money.

So at this gas station, I pulled out my wallet to contribute some cash.
Well, guess what? I didn't HAVE any cash!! Whoops.

So I offered to use my credit card to get them some gas. They in turn offered me the $5 they had collected so far.

That cinched the deal. I completely filled their gas tank and refused to accept the money. They were obviously grateful and relieved.

I wished them a safe remainder of their journey. And all three of us left that local gas station with smiles on our faces.

I firmly believe if your heart is responsive to those around you that there are times you may be at just the right place at precisely the right time to be able to help someone in need. That assistance doesn't need to be grand, nor monetary for that matter. Sometimes a kind word or a simple gesture can be just the very thing which one needs to get them through the day.

This young couple made my day!!!

Blogging Acts of Kindness

Join Bloggers around the Globe

in Random Acts of Kindness

December 17, 2007

Bloggers Unite challenges bloggers everywhere, on December 17th, to do something good offline — an act of kindness — and then post about it on their blogs, using words, pictures, and/or videos to tell the story.

The Acts of Kindness Challenge aims at putting a human face on bloggers who are responsible for so much good in the world. The goal is to expose their kindness and generosity as well as serve as an example to non-bloggers that volunteering for a charity, donating to a cause, or simply doing something kind for another person has a ripple effect around the world.

On Monday, I will share with you a recent experience which arose at a gas station. A Random Act of Kindness is often that....random. Acting spontaneously upon an unexpected opportunity brings a special joy. Planning to do something special in advance also brings pride and joy.

Join Bloggers Unite in spreading kindness throughout the offline community and blog about it on your site. Feel free to include a trackback link here for your readers to learn more.

"Maybe 20,000 bloggers, vloggers, and photographers will make a difference."

DC Council takes first step to clipping the wings of the pharmaceutical industry

Today's Washington Post reports a bold move by the D.C. Council to regulate pharma reps who peddle drugs to District physicians and hospitals. The SafeRx Act of 2007 breaks new ground in the effort to reel in the multibillion-dollar prescription drug trade. Below are highlights from the must-read article.

The D.C. Council voted 7 to 6 yesterday to give initial approval to legislation that would make the District the first jurisdiction in the country to license pharmaceutical sales representatives, a major blow to the prescription drug industry and one that could have national implications if states follow the District's lead.

"For too long, we have allowed profit and paternalism to be our guide for patient safety," said Council member David A. Catania (I-At Large), who has become known in national health circles as an industry watchdog. "The truth is, no one is minding the store."

After the vote, Ken Johnson, senior vice president of Pharmaceutical Research and Manufacturers of America, issued a statement through spokesman Jeff Trewhitt.

"We regret that the council voted in favor of legislation that creates unnecessary financial burdens for the District of Columbia at a time when the money would be better spent addressing a wide array of health care challenges confronting the city including HIV/AIDS, diabetes and heart disease," the
statement said. "The bill passed by the council puts the city into a regulatory arena that has been effectively addressed by federal laws and federal government agencies for years."

Under the bill, salespeople would have to be licensed and sign a code of ethics and would be regulated by a pharmacy board. To qualify for a license, the representatives, dubbed "detailers" in industry lingo, would have to be college graduates. They would also have to refrain from using titles that would give the impression that they are licensed to practice pharmacy, nursing or medicine.

The bill, which has several parts, also would ban pharmaceutical manufacturers from engaging in a practice called "data mining," when doctors' prescription data are used for marketing purposes without their knowledge and consent.

Critics say the information trickles down to detailers who can then target a doctor for a particular drug by looking at his or her prescribing habits. District doctors could opt in to the program to allow firms to get their prescription data from pharmacies.

New Hampshire, Maine and Vermont, which have passed similar legislation, are in court with data collection companies and manufacturers fighting the new laws. New Hampshire is appealing the decision of a U.S. District Court judge to block the state from enforcing its new data mining law on the grounds that it restricts commercial free speech.

The District could face the same fight, council members said.

Catania said that is to be expected. "They are taking their playbook from the tobacco industry," he said. "Sue, sue, sue."

Yesterday's vote, however, will not end the debate. The council must vote again Jan. 8 on final approval of the legislation.

Questcor's Senior VP and CFO, George M. Stuart, becomes the 1st Insider to Cash Some Profit

On December 6, 2007, George Michel Stuart sells 187,308 shares of QSC stock for $1,123,848. Stuart, the Senior Vice President of Finance and Chief Financial Officer of Questcor Pharmaceuticals, has been with Questcor since September 2005. Although cashing out for over a million dollars sounds like a lot of money, Stuart still has a position with 281,250 shares which carried a value of $1,687,500 at opening of trading today when the stock price was $6.00.

UPDATE: On December 10, 2007, Stephen LaHue Cartt sold 14,202 directly-owned shares of QSC stock for $85,354 and 35,400 Cartt Family Trust shares for $212,400. Cartt, the Executive Vice President of Commercial Development, has been with Questcor since March 2005. Cartt was the first executive hired at Questcor after the former CEO Jim Fares had been hired in February 2005. Currently, George M. Stuart and Stephen Cartt are the only executives remaining who had been brought on board by Jim Fares during 2005. (I wonder if they are in it for the long haul, or if they will be some of the next folks to jump ship.) Cartt also sold 75,000 shares today at $5.75 for $431,250. Those are some pretty pennies. Unlike Stuart who sold 40% of his total shares, Cartt sold a modest 16.5% of his position keeping 557,186 shares valued $3,064,523 at today's close of $5.50.

To make this story more interesting, remember that Questcor's stock price in August was a measly $.45-$.60 and looked like it just might crumble. But somehow, the stock has soared since the announcement of the 3rd quarter earnings in November. With a 1000%+ run-up, who would blaim Stuart for taking advantage of the opportunity to realize some gain. I would not be surprised at all to learn that other longtime investors have done exactly the same thing recently.

With the recently filed SEC Form 4, investors are probably concerned that the wind may be falling out of the sails and that the stock price will fall like it did briefly today to $4.55. At today's lowest dip, Stuart's remaining shares would have been valued at $1,279,688.

There are two ways to look at this: (1) This might provide another buying opportunity to those investors who believe that Questcor's unusual earnings in the 3rd quarter will be repeated for several quarters to come. (2) This may send a message to investors that insiders, especially those who are responsible for the finances of the company, may acknowledge the possibility that Questcor cannot, or will not likely, repeat their recent performance.

How you view this event truly depends upon what you believe. Personally, I believe that Questcor has exploited Acthar's orphan drug status to explode profits to an unrealistic level thus gaining the attention of Wall Street and bio-investors. Questcor's justification for the 1347% price increase in August was based primarily on the previous year's income losses, the nature of which is debatable. Throughout 2007, several of Questcor's executives and board members have resigned, presumably due to the failure of their management strategy.

But that doesn't keep the hopeful from touting Questcor's potential value, as in the following article published the very same day which Stuart's SEC Form 4 was filed reporting his recent sell-off of stock. Michael Anagnostakis, an independent stock broker/consultant in Newburgh, NY, thinks that Questcor is an "Undiscovered Biopharma Diamond in the Rough."

Michael Anagnostakis is the "founder and Principal owner of Independent Financial Consultants [IFC], a financial money management firm founded in 1988 that specializes in uncovering undervalued small cap equities. He has degrees in Economics and CS from NYU. The firm, its employees, and its clients, can and do hold long positions in the equities it uncovers."

From Manta On demand -
3 Brookside Ave, Newburgh, NY 12550-3018
Phone: (845) 565-7378
SIC: Security Brokers, Dealers, and Flotation Companies
Line of Business: Broker Dealer
As: Independent Financial Consultants
Est. Annual Sales: $180,000
Est. Employees: 2
Est. Employees at Location: 2
Contact Name: Michael Anagnostakis
Contact Title: Principal

Here is Mr. Anagnostakis' article with some commentary of my own -

"The joy of finding a hidden , unknown, undervalued treasure is universal in human nature. Whether one is in search of an antique, or a work of art, or a small Bio/Pharma company that is just turning the corner to large profitability, that search can be a long and tedious one. But, in each case, when finally discovered, the rewards can be tremendous!!

"One such hidden, unknown, undervalued Bio/Pharma company that has made an amazing transformation in its model of operation, and that is now leading to a dramatic profit story, is Questcor (Amex: QSC).

"Questcor Pharmaceuticals, Inc., (QSC) is a specialty pharmaceutical company, and focuses on novel therapeutics for the treatment of diseases and disorders of the central nervous system. It owns and markets two products in the United States, H.P. Acthar Gel and Doral.

"H.P. Acthar Gel is a source of adrenocorticotropic hormone and is used in various conditions, including the treatment of periodic flares associated with multiple sclerosis, infantile spasm [IS], opsocus myoclonus syndrome [OMS],and various forms of arthritis. Acthar also has various other labeled indications and uses in certain endocrine disorders, rheumatic disorders, collagen diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, and gastrointestinal diseases.

• Acthar has only one FDA-approved indication which is for the treatment of periodic multiple sclerosis exacerbations. Within the MS market, Acthar is not the first choice among the majority of MS patients and their doctors for that purpose. Acthar is an old drug and has been around since the 1950's. Questcor purchased Acthar from Aventis in 2001 and was not involved in discovering it's usefulness in Infantile Spasm. However Questcor is currently focusing their attention on the use of Acthar for the treatment of Infantile Spasm and hope to gain FDA approval for that indication.

"Doral is a product indicated for the treatment of insomnia, characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

"The basis of the companies new business model centers around Acthar and the Company has a registered trademark on H.P. Acthar Gel.

"For years, the company was hemorrhaging money at a rate of $1 million per month and ran quarterly losses. Starting in May of this year, three impressive changes to the business model, changed all that and transformed the company going forward. Questcor is now very profitable and generating large positive cash flows!

"On May 25, 2007, the Company completed the reduction in its field organization from 45 sales representatives to 10 product service consultants and 3 medical science liaisons. The Company expects this reduction to generate annual cash savings between $4.0 million and $5.0 million. In addition, other cost reductions are expected to increase the annual cash savings to a range of $5.0 million to $6.0 million.

• The sales reduction appears to be a reversal of the sales increase in 2006. These are not employees who had been with the company for an extended period of time. The product service consultants are most likely the ones responsible for investigating insurance coverage for patients prescribed Acthar. If insurance won't pay, then the consultant refers the patient to NORD (National Organization for Rare Disorders) who administers their assistance program. If the patient qualifies with undisclosed income/resource requirements, then NORD grants coverage through their program.

"During July 2007, the Company began utilizing CuraScript, a third party specialty distributor, to store and distribute Acthar. Effective August 1, 2007, the Company no longer sells Acthar to wholesalers and all of the Company’s proceeds from sales of Acthar in the United States are received from CuraScript. The Company sells Acthar to CuraScript at a discount from the Company’s list price. CuraScript sells Acthar primarily to hospitals and specialty pharmacies. Product sales are recognized net of this discount upon receipt of the product by CuraScript. CuraScript has 60 days from when product is received to pay the Company for their purchases of Acthar.

• Control distribution = better control price.

"In August 2007, the company announced a new strategy and business model for Acthar, and initiated a new pricing level for Acthar. Under this new orphan-drug-style pricing model strategy, the sales price to CuraScript, increased to $22,222 per vial based on a list price of $23,269 per vial. The list price prior to the new pricing level was $1,650 per vial.

• 1347% increase!

"Results were explosive in the third quarter ended September 30, 2007. Net sales of Acthar for the three month period ended September 30, 2007 totaled $14.6 million as compared to $3.8 million during the same period in 2006. The increase in net sales resulted from the initial success in the implementation of the new strategy and business model for Acthar. Total net sales were $14.8 million for the three month period, as compared to $4.0 million for the same period in 2006. In addition, the gross profit margin percent increased to 90 percent for the quarter ended September 30, 2007 as compared to 77 percent for the same period in 2006. Further, SG&A expenses have decreased due to the reduction in its field organization and other cost reductions outlined above. Net income applicable to common shareholders totaled $8.4 million, or $0.12 per fully diluted share, for the third quarter of 2007, compared to a net loss applicable to common shareholders of $(1.5) million, or $(0.03) per share, for the third quarter of 2006. As of September 30, 2007, Questcor has 69,296,099 million fully diluted common shares outstanding.

"During the quarter ended September 30, 2007, Medicaid rebates and government chargebacks, related primarily to activity prior to the implementation of the new Acthar strategy and thus resulted in a one time increase in net sales and net income by $4.5 million, or $0.07 per fully diluted share. Future sales may comprise of about 30% Medicaid cases and we have thus factored in recognition of minimal, if any net sales on these units within our revenue forecasts.

• So the Q3 net income of $8.4 million includes a one-time increase of $4.5 million leaving $3.9 million net income a more realistic expectation if sales repeat at the same level hereforward.

"Since the close of the third quarter, the viability of this new pricing model has been further confirmed by sales data for October and November, which shows a consistent level of ordering and insurance reimbursement experienced since the implementation of the new strategy. Indeed, data suggests that sales may have even accelerated from the initial September period with unexpected sales beyond the IS and OMS markets.

• Stocking up by specialty and hospital pharmacies does not necessarily indicate that end-use demand has increased. In fact during Questcor's presentation at the BMO Conference on December 4, the CEO explained that patient demand had remained at 425-475 units per month which is an approximate 30% decrease from the months preceeding the price increase.

"Although no drug is approved in the United States for the treatment of IS, Acthar is not indicated for, but is used in treating patients with infantile spasms (“IS”), a rare form of refractory childhood epilepsy. Despite lack of indication, Acthar is the "gold-standard" for use in such cases by many Neurologists, with company holding an estimated 40%-45% of the IS market. No generic competition is ever likely due to high barriers to entry. A complex, multi-step manufacturing process involves extensive proprietary knowledge and thus is tremendously difficult to reproduce. With minimal Doctor and patient education initiatives, company may be able to expand usage within IS to the 50% level.

• "Gold standard" was the term used during the BMO Conference, but there is not evidence of this as absolute truth. In fact, the CEO was unable to sufficiently answer one Dr. Levine's questions regarding the market for IS treatment in the U.S. and abroad. A CEO who doesn't have a grasp on the competition...not very reassuring in my book.

"Additional future growth prospects are very promising:

"In June 2006, the Company submitted a Supplemental New Drug Application (“sNDA”) to the FDA and is currently pursuing formal agency approval for Acthar in the treatment of IS. On November 9, 2007, the Company met with the FDA to further discuss its sNDA. At the meeting, the FDA concurred with the Company’s suggested pathway to preparing a complete application for FDA review, which will involve submission of additional gathered data on past trial information to the FDA. No drug is approved in the United States for the treatment of IS. Currently, no additional clinical trials are needed and due to the long safety and efficacy record of Acthar, we expect possible FDA labeling for IS use in the first quarter of 2009. Under such labeling, penetration of the IS market in the United States could approach 90%-95% over time.

• So after receiving the non-approval action letter in May, Questcor finally met with the FDA to discuss their application on November 9 immediately preceeding the release of their Q3 earnings. Timing does not simply happen by accident.

"Company should also be able to pass along smaller incremental price increases over time, adding to future growth rates.

• Smaller incremental price increases? Wasn't 1347% enough?!! Already a typical course of treatment is expected to cost $100,000.

"Additionally, growth prospects internationally may be available in the future due to the lack of a completely safe alternatives worldwide.

• "Completely safe alternatives"? I would challenge Questcor to make a concrete claim that Acthar is a completely safe treatment choice.

"Further, Acthars anti-inflammatory properties may lead to future further indications.

• Always possible, but Questcor has yet to pursue any other indications in the 6 years since purchasing rights to Acthar Gel.

"Next, the Company is also developing new medications, including QSC-001, a unique orally disintegrating "fast-melt" tablet formulation of hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately severe pain, to be used with patents that have swallowing difficulties (30-40% of ALL pain patients). This is currently the largest prescription market in the United States, with 113 million prescriptions annually. The product is being formulated by EURAND N.V. using proprietary delivery technology. QSC owns worldwide commercialization rights on this product, and are pursuing a 505b2 regulatory pathway to market. This is a relatively fast to market program, and we anticipate meaningful results to hit in the second half of 2009.

• One medication does not qualify as plural medicines. Enough said.

"Lastly, the Company is in early stages of developing additional new medications using strategies that generally require lower capital investment when compared to traditional development programs.

"At the close of the third quarter on September 30 2007, the Company’s cash, cash equivalents and short-term investments were approximately $10,592,000 and its accounts receivable balance was $14,149,000. Current assets to current liabilities ratio was 5.86 to one and is growing stronger at a fast rate in the forth quarter. Company has no LTD. As of November 30, 2007, the Company’s cash, cash equivalents and short-term investments have grown to approximately $20 million and its accounts receivable balance was approximately $24 million. Remember, the Company provides 60 day payment terms to the distributor of the Company’s products in the United States and thus we expect Cash amounts to build substantially by the end of the fourth quarter.

"Given a very favorable balance Sheet, and favorable valuation levels, based on our above analysis and earnings estimates, A BUY rating is indicated on the stock of QSC, which had a closing price of $6.00 on Friday December 7, 2007. Based on the Bio/Pharma industry average PE of 27 for the universe of only those PROFITABLE Bio/Pharma firms (on a trailing 12 month basis), our price target on QSC for year-end 2008 is $31 per share. For the year-end 2009, our QSC target price is $57 per share.

Disclaimer: Author's financial firm, Independent Financial Consultants [IFC] is long QSC.


***Note the above article was not written by THIS blog's author, it is merely taken from SeekingAlpha site.


Then there is Michael Shulman's article The Non-Orphan, Orphan Drug Company which reveals sloppy research in itself.

So you may ask - "Lisa, why do you care so much about this minor drug company?"

Well, it is because Questcor Pharmaceuticals appears to have...

(1) used misleading justifications for increasing their price of a drug which they didn't research and develop and which has modest costs incurred to manufacture.
(2) exploited Acthar's orphan drug status to implement a greedy business strategy which is currently serving as a money-magnet....that's money ultimately taken from patients both insured and uninsured.
(3) provided extremely generous salaries and bonuses to executives and boardmembers while later claiming extreme income losses.
(4) created a stockmarket flurry to attract investors and to validate their business model.
(5) made several savvy investors a great deal of money in the process.

Big Pharma and Bad Press Go Hand-in Hand?

Can't the Big Bad Drug Industry do anything right?

Today I came across a PharmaFraud article - The Old "Two Sets of Books" Scam - which discusses a little provision buried within the Medicare Modernization Act (MMA) which Big Pharma helped to get passed. This little item allowed Pharma Manufacturers to send one set of drug price data to the federal government, and another set to the States.

The MMA requires Pharma Manufacturers to report average drug prices to the Federal Government, but the Federal Government is not allowed to give this pricing information to the States. There is only one reason that Big Pharma pushed through such a ridiculous clause; to defraud the government.

Big Pharma sends false drug prices to the federal government, the States send utilization data to the federal government, and the federal government verifies the URA (Unit Rebate Amount), calculated by the Manufacturers; a calculation that is based on the Pharma Manufacturers phony prices.

A recent document made public in Re: Pharma Industry AWP Litigation, reveals Abbott's use of "two sets of books" (For additional background, review PF's post; The Five Sets of Books Methodology for Covering-up Fraud and Hiding Drug Diversion). Recently, the DOJ issued a subpoena seeking unit, price, and rebate data for several drugs made by Abbott. The State of Texas had previously served Abbott with a subpoena in which they requested and received the same data. But guess what; Abbott sent one set of data to Texas, and a different set of data to the Feds.

Humm...doesn't sound too good for Abbott.

Then, I find an announcement which PhRMA released today regarding the wonderful goodwill which the pharmaceutical companies are providing to those in need.

The Pharmaceutical Industry provides Relief to Mexican Flood Victims

The pharmaceutical industry has quickly come to the aid of over one million people who have been affected by the flooding caused by Tropical Storm Noel in late October and early November in the Tabasco and Chiapas regions of southern Mexico.“The flooding in Mexico has caused serious damage to the Chiapas and Tabasco regions, which puts the many people who live there in danger,” said Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin. “Our member companies are supporting the aid workers in their fight against potential diseases and other health related problems that could arise as a result of the flood.”PhRMA member company contributions have included:

Abbott’s donation consists of 28,000 boxes of antibiotics, 94,000 bottles of serum, 7,000 packages of infant formula, 46,000 nutritional supplements, and 100 glucose meters with 10,000 reactive strips. In addition, Abbott has donated the resources for HIV and Hepatitis A, B and C exams and
blood tests. It has also provided the materials to reactivate the operation of the blood bank that services several hospitals in Villahermosa.

GlaxoSmithKline (GSK) has made a donation of medicines and OTC products valued at more than $580,000. The contribution comprises quantities of Ceftin and Bactroban, which is valued at around $100,000, as well as Septrin, Amoxil, Zentel, Virlix and Zovira. GSK will be working with its donations partner, AmeriCares, and its in-country partners, the Mexican Order of Malta, to distribute the products.

Johnson & Johnson is distributing OTC drugs, antibiotics, wound care products, and food and water through its disaster relief partner, AmeriCares. It also guarantees that any U.S. based employee of Johnson & Johnson will have their contributions to the flood victims matched 2-for-1
through their Matching Gifts Program.

Merck is donating $50,000 in cash to the American Red Cross and working closely with their partners on the ground to assess the situation and provide any medicine and support that will be requested in the future.

Pfizer contributed $17,000 from its disaster relief fund which was matched by Corporate Affairs Mexico for a sum total of $34,000 allocated for reconstruction works. It also donated drinking water as well as other needed supplies and contributed medicines worth $80,000 channeled through the Ministry of Health. To its Tobasco based peers, Pfizer donated a sum total of $17,000.

Schering-Plough is distributing to its colleagues in Mexico cash donations and medicines for adults and children, such as antibiotics, antifungals, pain medicines, and treatments for colds and flu. Moreover, it is delivering supplies such as groceries medical supplies, cleaning agents, house
wares, as well as other items.

Wyeth is donating 18,600 units of nutritional products (SMA, Promil and Progres), as part of a national “United for Them” relief initiative, which includes other major companies as well as Televisa, Mexico’s main TV network.

If I'm not mistaken, aren't these the same Big Pharma companies which have been getting a lot of bad press and are just a little in trouble with the feds right now?

But hey, at least that may actually be helping some folks who need the help right now.

I'm glad for that.

Cavalcade of Risk #40 is Up!

Joe Paduda hosts this week's Cavalcade at Managed Care Matters. Joe highlights 21 of the best risk-related posts from around the Blogosphere.

He may not be interested in meeting Montel or even mentioning who Montel speaks for, but he does include my post Is Montel Williams Disturbed by Big Pharma?

Is Montel Williams disturbed by Big Pharma?

Controversial behavior by Montel Williams, spokesman for PhRMA's Partnership for Prescription Assistance, may bring unwanted attention to Big Pharma's great PR machine. (h/t Cary Byrd at eDrugSearch Blog)

As reported, the 'Help is Here Express' blew through Savannah Georgia to promote the hope of 'free or nearly free' drugs to qualified individuals. This Orange Bus travels the country promising that it's program helps to save lives...by providing medications to uninsured patients.

Montel Williams has multiple sclerosis, as do I, and has been the visible image of PPArx since . Now I've got my own opinions as to the quality of assistance which Billy Tauzin and his Orange Bus purport to provide needy individuals. [see PhRMA and PPArx: How much are they really helping patients in need?]

Previously, I've given Williams the benefit of the doubt regarding the use of his image to promote a glossed-over PR concoction. I have no doubt wondered as to the level of compensation the Big Pharma lobby may be providing him, but I've let it go.

Last Friday, Courtney Scott, a high school intern at the Savannah Morning News, interviewed Williams for the paper. But apparently her 2nd question touched a raw nerve.

Excerpt from Savannah Morning News online:

Before the rally in Johnson Square, Williams stood for an interview with Scott.

With her second question she asked, "Do you think pharmaceutical companies would be discouraged from research and development if their profits were restricted?"

It was a question she came up with after discussing the issue with her Advanced Placement English teacher.

Williams bristled.

"I'm trying to figure out exactly why you are here and what the interview is about," he replied.

He asked if she suffered from any illness, to which she answered no.

"I'm here as a patient advocate talking about the fact that medications available today are saving people's lives, that's what saving mine and after that, this interview is done."

He snapped his fingers, said thanks and walked away.

"That's an absolutely fair question to someone who represents the pharmaceutical industry," said Savannah Morning News Executive Editor Susan Catron.

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said the question would have been better directed to himself because he represents the drug industry, and Williams is paid to raise awareness of the drug program.

Yup, that's it. A paid endorser is not in any way responsible for having an opinion on the item being endorsed. However, I believe that any paid spokesperson should be educated and well versed on the subject of that endorsement. Williams could have simply responded that the question presented be directed to the individuals representing Big Pharma itself, not to the star of the Orange Bus Circus.

Later that day, Scott was at the Westin Hotel preparing for an unrelated interview when Williams approached her and delivered a threat. MSNBC reports Montel threatens to 'blow up' teen reporter. Savannah Morning News says Montel 'blows up' at local reporters. My favorite is from eDrugSearch Blog Big Pharma Flack Montel Williams can't take the heat -- from a high school interrogator!

But I guess that all should be excused as Williams offers On-Air Apology to Teen Reporter (AP Press). Scott may take the offer, but she should be prepared to face numerous slick-talking representatives of PhRMA. And representatives are numerous indeed as Big Money is being spent by Big Pharma to represent and educate many of us, including our lawmakers in Congress.

As far as PhRMA's Partnership for Prescription Assistance goes, here's a brief rundown of my personal experience, excerpted from a previous post - Rx Outreach Rocks!

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.

Perhaps PhRMA and Montel Williams need to lower their perceived risk of personal attack by actually doing a better job of providing the information and services which they are promoting.

And to the companies and lobbyists of Big Pharma, please use your resources for real R & D and stop spending so much money, time and energy on 'educating' and 'selling' us of your wonderful intentions, products, and services. We'd all be better off for it.

UPDATE: Prescription Access Litigation discussed Montel and PhRMA on their own blog, sharing my views. Expert below:

So why was Montel so angered by this question, a question which arguably invited a stock answer that PhRMA reps repeat dozens of times a day? It’s not as if the reporter asked “Why doesn’t the pharmaceutical industry make its Guiding Principles on Drug Advertising mandatory and enforceable?” And it’s not as if the reporter asked some obscure question on some obtuse point of, say, patent law or the issue of follow-on biologic drugs. It’s surprising that the industry’s main spokesperson for its patient assistance program was so poorly prepared to answer such an easy question.

But perhaps all this is beside the point. Does it ultimately matter if Montel Williams answers questions about the industry’s priorities and policies, or any questions beyond the mechanics of this patient assistance program?

The answer is, yes, it does. Montel Williams has become one of the most visible spokespeople for the industry. He lends his name and his credibility to the cause of burnishing the image of America’s pharmaceutical companies, and is paid (presumably handsomely) to do so. So it’s entirely fair that he be asked questions about the industry. Although perhaps Ken Johnson, PhRMA’s Senior Vice President of Communications, is the better person to ask this kind of question, Montel is fair game as well — by accepting the industry’s money, and acting as his spokesperson, he has to take what comes with that — including fair questions about the industry’s misplaced priorities.