Merck Purchases Insmed – Biosimilar Biotech Drug Company

If you thought competition was tough with generic drugs, there’s a new kid on the street, biosimilar drugs.  The link below goes to a page on the Genentech website that explains the process in full detail.

“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”

Unlike generics that have to maintain the same properties, biosimilars are a bit different in the fact that they cannot be exactly the same; however, the drugs are to be used to treat the same ailments and diseases.  This gets a little sticky as with generic drugs, the properties of the name brand drug are somewhat of a basis for approval, while biosimilars are a bit of an open ball game, being this is a somewhat new field to be explored as well as their potential requirement to adhere to the same clinical trial structures as the original drug. 

That being said, the purchase of Insmed, a biosimilar company by Merck somewhat tells the direction of pursuit that is to follow from some of the major investors, drug companies.  This could stand to open up new markets and pricing for many of the biotech related treatments if biosimilars begin to compete with the initial name brand drug.  There are ongoing meetings with the FDA on how intellectual property is viewed as well.  The video below talks about the business model and desires of the Biosimilar company.  BD   

If Merck's creation of its BioVentures group got our industry talking about pharma's role in FOBs, you can expect the clamor to grow even louder now. The company's willingness to fork over $130 million for Insmed's full capabilities shows that it is playing offense when it comes to FOB capacity. Indeed, Merck and Teva have emerged as the preeminent players in pharma's race to develop FOBs.

The deal, announced on February 12, extends Merck's biologics capacities tremendously, giving its Merck Bioventures unit two additional clinical stage programs--a Neupogen follow-on called INS-19 currently in Phase III, and a Neulasta follow-on in Phase I known as INS-20--as well as preclinical versions of Epogen and an interferon-beta 1b molecule.
"Insmed's pipeline of follow-on biologic candidates presents the opportunity to expedite Merck's entry in the biologics marketplace," said Frank Clyburn, SVP and general manager of Merck Bioventures in a press release announcing the news.

The IN VIVO Blog: Merck Bulks Up With Insmed FOB Acquisition

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Technorati Tags: Merck,Insmed,Biotech,Follow On Biotech,drug manufacturers,Biosimilar Drugs,pipeline

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Mayo Clinic – Madoff connection with funding Gastrointestinal Research

This somewhat of a strange twist that the donors of the funds required that the money be invested with Madoff.  The article from the Wall Street Journal states it was a significant loss for gastrointestinal research, but also a small portion of their overall funding. It’s been since December 11th, and it seems more and more victims unfortunately keep surfacing.  BD

Mayo Clinic has learned that a free-standing charitable trust established to fund Mayo research, practice and education in the area of digestive diseases was under the management of Bernard L. Madoff Investment Securities. The investment firm was not retained by Mayo Clinic. The trust agreement required that the Madoff firm manage the trust’s assets.

The affected endowment fund has provided annual distributions to Mayo Clinic over time. The fund is only one of many sources of funding for Mayo Clinic GI research, practice and education initiatives. This situation will not affect provision of care to patients in gastroenterology or any other specialty.

Mayo Clinic has never used the Madoff firm as an investment manager for any of its own operating, endowment or pension funds. The firm was retained by the Miles and Shirley Fiterman Endowment Fund for Digestive Diseases to manage the trust’s assets. The trust is governed by five trustees — two appointed by the Fiterman family and three appointed by Mayo Clinic. The trustees receive no compensation or other benefits from the trust and had no discretion over investment of the funds, since use of Madoff Investment Securities was specified as a term of the Trust Agreement. The trustees do not yet know the full extent of the losses of the trust.

NOTE: Please share this information with staff in your area as appropriate. This notice is being sent to Mayo Clinic consulting staff, residents, fellows, and supervisory and administrative staff at all campuses.

Health Blog : One Other Health Outfit Stung By Madoff: Mayo Clinic

Technorati Tags: Madoff,Mayo,Gastrointestinal Research,philanthropy,healthcare,charity

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Technorati Tags: Healthcare Plan,healthcare,algorithms,"Hands On Technology",Congressional Algorithms,Technology,medical records,SEC,FDA,Madoff,charities

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Johns Hopkins President sends an email broadcast– Impact of National Economic Situation

This is a letter emailed today outlining a conservative approach to spending due to current economic times and he also notes he has no real input as far as the immediate future of philanthropic support.  Leaders are taking a pay cut, no raises, freezes on hiring, etc.  Also specifically mentioned are the insurer reimbursements at the school of medicine being taxed and pressured.  BD 

---

Office of News and Information
Johns Hopkins University
FOR IMMEDIATE RELEASE
CONTACT: Dennis O'Shea

A Message from President Brody
to the Johns Hopkins Community

President William R. Brody sent a broadcast e-mail message to Johns Hopkins University faculty, students and staff on Friday, Feb. 13, regarding actions being taken in response to the impact of the national economic situation on the university. Here is the text of that message.

Dear Faculty, Staff and Students:

I wrote you late last year about the state of the U.S. economy and the potential impact of deteriorating conditions on the university. The situation, obviously, is still very difficult, nationally and, in fact, internationally.

Businesses and banks have failed. GDP is down. Unemployment is up. Many of us have relatives or friends who have lost work. Given the performance of the stock market, almost all of us are concerned about our personal financial situations, at least in the near term.

Johns Hopkins has provided, thus far, an important counterbalance to the bad economic news. We remain the major private employer in Maryland and a significant economic force in the entire Baltimore-Washington area. We attract considerable federal research funding into the region, much of which works its way — through your paychecks and our vendors — into the local economy. With major projects well under way in East Baltimore and at Homewood, we help to insulate the area's construction industry from the worst effects of recession.

The recently completed Knowledge for the World campaign has greatly strengthened the university's ability to withstand these tough times. For instance, we have not had to impose major cutbacks in our construction and renovation program; many large, important projects have been completed and many that have not are largely supported by gifts to the campaign, not by the operating budget.

Likewise, the addition to endowment of support for 92 faculty chairs and 550 scholarships and fellowships has made us stronger in the face of financial adversity. These new endowments will put us in an even better position once the investment markets recover.

But we cannot pretend that the economic storm has bypassed the university. It most certainly has not.

For instance, our investments, like everyone's, have taken a significant hit. In the first six months of the current fiscal year, through Dec. 31, Johns Hopkins endowment investments lost about 20 percent of their market value. That is actually a pretty good performance, under the circumstances, certainly better than the benchmarks against which we measure our endowment performance. But such a loss does hurt. We now project that the amount of operating cash generated by the endowment will remain flat in fiscal year 2010 and will decrease in 2011 and 2012.

Some of the other problems we face: This year's Maryland state support for independent higher education has been cut; the state's budget will be very tight for at least the next two years. Federal research funding, especially in the life sciences, has been constrained for several years, as have the facilities and administrative overhead reimbursements that accompany that funding. Though our alumni and friends are loyal, committed and very generous — more than 250,000 of them contributed to Knowledge for the World — the immediate future of philanthropic support is uncertain.

Insurer reimbursements to the School of Medicine for patient care also are under pressure. And, university-wide, we must be even more sensitive than ever to the possibility that the financial circumstances of our students and their families will change during the course of their time at Johns Hopkins.

We have not been idle in addressing these challenges. Some divisions have postponed searches for faculty positions. Some are leaving staff positions unfilled. Some units have frozen or cut operating budgets. Some have adopted new money-saving energy conservation programs.

Recognizing, as we traditionally have done at Johns Hopkins, that each unit's situation is unique, the deans, directors and vice presidents have worked hard to cut expenses within their own areas of responsibility. This approach has served us well and has helped us reach most of the budget targets we need to reach in the current fiscal year, which lasts until June 30.

Looking ahead to fiscal 2010 and the years that follow, we will continue that approach to our problems to the extent that we can. Our decentralized governance is a great strength of our university.

But the problems are very large. We now project that university revenues during fiscal 2010 and fiscal 2011 will be a total of more than $100 million short of previous estimates. I believe it is now clear — much clearer than even a few months ago — that we will have to take some unified, across-the-university measures in response to those challenges. The deans and directors have been working with central administration to chart this common approach. Our priorities are to preserve the excellence of Johns Hopkins in teaching, research and patient care and to address, to the extent that resources allow, changing financial circumstances of returning students. We also hope very much to preserve, to the extent that resources allow, our most important resource: our employees, both faculty and staff. We believe that the measures we have chosen to take will, in fact, help us preserve jobs and keep valuable employees on the payroll.

I have been working closely with President-elect Ron Daniels on these issues. He has been an integral participant in our deliberations, supports the decisions we have made, and will be fully up to speed when he takes office.

Effective July 1, all members of the executive leadership — the president, the divisional deans and directors, and vice presidents — will voluntarily reduce their salaries by 5 percent. Savings will be used to fund divisional priorities, including student aid. Savings from central administration will be added to undergraduate financial aid budgets.

We are instituting the following three measures in university administration, the academic divisions and other non-APL areas of the university. (Because of its different business model, APL will operate under different constraints.)

Starting immediately, and effective through June 30, 2010, we are freezing hiring for both faculty and staff positions. We are also freezing staff reclassifications. In both cases, rare and essential exceptions can be approved by the appropriate dean, director or vice president.

There will be no salary increases, except those that are contractually obligated, in the fiscal year beginning July 1. Exceptions will be considered by deans and directors only if necessary to recruit or retain key talent, to reward faculty in the tenure and promotion process, or to compensate staff for assuming additional responsibilities as a result of more effective conduct of our business, or if the increase is directly related to new revenues such as research grants.

Overtime is to be eliminated, except as approved by a dean or director to fulfill a unit's core mission. Similarly, there will be no use of temporary agency employees or independent contractors to cover unfilled positions, unless approved by a dean or director.

There are no two ways about it: The years ahead are likely to be difficult. But this university has endured heavy weather before. It has a history of facing challenges head-on, dealing with them, and emerging from troubled times ever stronger. I have no doubt that will happen again in this recession.

And while this is a time of serious challenges, it is also a time of important opportunities, opportunities that we should and will aggressively pursue. The stimulus package now close to final passage in Congress will include, for instance, significant funding that can both advance research on critical scientific and medical questions and support much-needed job growth.

There are other opportunities we should seize as well, including improvements to our business practices that increase efficiency and eliminate unnecessary expense. Many of you already are making excellent suggestions for such improvements. Thank you, and keep it up.

I am grateful to everyone at Johns Hopkins for your loyalty and service to the university, in good times and bad. We must be straightforward and direct in addressing our problems but we also must never lose sight of our strengths. And at Johns Hopkins, our greatest asset is you.

Sincerely,
Bill Brody

Headlines@Hopkins: Johns Hopkins University News Releases

Technorati Tags: Johns Hopkins,economy,philanthropy,budget

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Health Insurance Inadequate for Cancer Care

This has been a large lobbying act by drug and device manufacturers not to lose sales to some degree.  Sure there are generics that work as well as name brand drugs and we seem to have plenty, but when it comes to specific new cancer drugs, well those generics of course are not there yet.

Some major pharma companies make their own generics that compete with their name brands, I guess this helps with capturing more market share overall.  The statement below was from a study on cardiology drugs, but again the diagnosis, treatment and drug availability all enter in to the picture for each person individually.  I would guess if everyone was taking generics, that wouldn’t leave much room for name brand drugs, so after the patent expires, it would appear it becomes a very generic world after all.  Again, that is talking generalities and not specifics. 

“They were found to be no better than generics by a review of the available medical evidence published in the December 3 issue of the Journal of the American Medical Association. Dr. Aaron S. Kesselheim, the studies lead author said.”

The fear is that some drugs could be put out of reach for patients, but that is already going on big time and when there is no generic, well that is another decision of another type at that point and what is most critical, especially with cancer drugs with new markers and proteins being found and identified almost daily, the development and research changes at right about the same pace, and the cost at that end probably won’t be decreasing for quite a while.  In the meantime, will insurance pay for these treatments, that is the catch 22.  It’s not necessarily about the more common name/generic drugs on the market.  BD  

For people stricken with cancer, having health insurance is no guarantee they will be able to afford the care they need. That sobering fact is illustrated in a new report with the stories of real people suffering needlessly in their time of crisis. As if fighting the disease were not difficult enough, cancer patients too often have to fight our dysfunctional health care system as well.

The report, Spending to Survive: Cancer Patients Confront the Health Insurance System (PDF), was produced by the American Cancer Society and the Kaiser Family Foundation. It tells the stories of hardship faced by 20 cancer patients and survivors while navigating the bewildering world of health insurance and cancer treatment. According to the report, the stories featured in it "are among the more than 20,000 people who have called the American Cancer Society Health Insurance Assistance Service because they are having trouble finding adequate and affordable health insurance or are struggling to pay for health care despite being insured."

Health Insurance Inadequate for Cancer Care and How That Relates to the Economic Recovery Package | OurFuture.org

Technorati Tags: health insurance,healthcare,generic drugs,congress,lobbying,drug manufacturers,medical device manufacturers

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This ER Physician likes PHRs, His Records are implanted in a chip from his military days

This physician has also been on the ground working during hurricanes too, thus he can pretty much tell it like it is.  The article states now it is time for the individuals and physicians to move forward.  He’s not recommending a chip for everyone, but rather some type of personal record.  He wears dog tags to direct people to how to find a reader for his chip, so the chip in this instance could be somewhat of an additional step. 

The PHR is not gaining from the stimulus bill, but as a bi-product will continue to grow.  I like the terminology used here when comparing EHRs and PHRs, the EHR being the front end and the PHR, being the back end.  The PHR is much more valuable when fed the information from an EHR and credible vendors or medical devices that automate the process.  BD 

It should come as no surprise that Maurice Ramirez -- an emergency room attending physician with Florida Hospital's Flagler division -- is in favor of widespread adoption of automated personal health records, or PHRs.

Ramirez was once chief medical officer for a company that was developing such an application, but that's not his only reference point. He has also been on the ground in the wake of many disasters, including the aftermath of Hurricane Ike, which struck Galveston, Texas, last year.

What the medical industry is hoping is that as the stimulus drives more investment in the back end -- that is, EMR systems -- more private sector companies will be willing to invest in the PHRs in the front end. Certainly, demand for these applications will rise as more consumers see what they can do.

CRM News: Healthcare: The Way Forward for Personal and Electronic Medical Records

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Cleveland Clinic and Selected Minute Clinics to Share Medical Records

 As you may or may not be aware, all of the Minute Clinics found in the CVS stores already use an electronic medical records program.  With their system, the chart information can also be shared with Google Health and the HealthVault. Cleveland Clinic is now going to integrate further with clinics that are in the geographical area served by the hospital and with the patient’s permission, records from the hospital can be shared with the physician’s assistant at the Minute Clinic and vice versa.  If a patient had recently been seen at the hospital, all medications, tests, etc. would be available to view a the clinic.  9 stores will be connected before the end of the year.

Also not too long ago, I wrote about the pilot program at Cleveland Clinic with Microsoft HealthVault, whereby patients in the study have been given devices that connect to the software and post and glucose and heart rates to the computer, all one needs to do is hook up to the computer via USB.  BD 

Cleveland Clinic and Microsoft HealthVault to track chronic diseases at home with Medical Devices

MinuteClinic Inc. will collaborate with the Cleveland Clinic at several MinuteClinic locations inside CVS/pharmacy stores in northeast Ohio.

By the end of 2009, the the collaboration will include nine locations, each staffed by a MinuteClinic nurse practitioner and a Cleveland Clinic Health System-appointed medical director.

As part of the deal, Cleveland Clinic and MinuteClinic will fully integrate their electronic medical records to streamline communications around all aspects of a patient’s care. Each Cleveland Clinic-affiliated MinuteClinic will have access to a patient’s Cleveland Clinic MyChart electronic medical record, which includes medical history, prescriptions, treatments and health maintenance information, if the patient gives consent.

MinuteClinic, Cleveland Clinic to collaborate in Ohio - Minneapolis / St. Paul Business Journal:

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Technorati Tags: Health IT,Senate Hearings,Budget,heatlhcare,medical records,personal health records,integration,interchange,HL7,CCR,Minute Clinic,standards,Cleveland Clinic

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Peanut Corp. of America files for bankruptcy – Chapter 7

This probably doesn’t some as a surprise as in the aftermath, would anyone buy their products again?  When it comes to lawsuits on the issue, King Nut Co. and Kellogg Co. are also involved as they used their products. 

The FDA has even created a widget to post listing all the products.  (See below) You can also share and use the widget as well.  At first the issues seemed to be overseas with food products and drugs, and now we are having our own problems.  Sad that people had to die over the poisoning too.  The sooner the FDA can get a bank of servers taking in quality control numbers and stats from manufacturing plants, the better assurance we may have on the content of the food we eat  The peanut company had even changed labs as one had been to tough on the numbers I read in another article, so again, perhaps adding some technology here with an automated reporting system, both here and otherwise would help, and it would also serve to help FDA enforcement agents as well to be triggered to a factory with issues immediately.  BD 

One of my ideas from a prior post:

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good.

One thing in particular that springs to mind for me here here is perhaps some use of business intelligence for monitoring.  This is not a cure all for the entire process, but technology can aid and offer some nice assistance here.  A reporting function would need to be set up to automatically report back to a central agency on criteria established for each drug or food product.  At the receiving end, anything out of tolerance would be immediately sent to an alert.  Now granted, this should be done locally from every plant, but when you can’t physically have agents in place at every factory all the time, this could offer some real relief and help.

With today’s speed of data transmissions, a server farm could be set up to monitor this type of activity and before an over seas factory began to export to the US, this would be a prerequisite to be established.  Each lot before packaged would send the chemical content back to the central gathering agency and report in, with both the US agency and the local factory itself having the information at hand. 

Again, this comes back to adding some new software and algorithms to the process, but computers could provide this information in a couple of seconds.  Audit trails would also be there to allow for checking back on submissions.  A bank of sophisticated server farms could do the work.  This would also tend to build product credibility as well if everyone knows up front that the chemical content was being reported before the end packaging occurs.  Again, not to replace an actual physical inspection all together, but, it would also stand to make those inspections much more information rich and valuable and create safe consumable products.

We do so much today by remote transmissions with information reporting, why not put in in place and use it where it is vital.  This could also be done globally too, with each country receiving reports on products they import from other countries.  It would sure beat some of the guesswork we see out there today, not to mention illnesses and death from products that are tainted or contaminated.  With the global economy changing every day, it makes sense to know what we are getting and it is impossible to physically monitor all the systems without using some modern day technology.

A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don’t  incur the long time delays in figuring out which lot went where, no more blind shipping documents as they exist today.  Wonder why this process has not been considered yet?  BD 

FDA Product Recall List

ATLANTA (AP) — The peanut processing company at the heart of a national salmonella outbreak is going out of business. The Lynchburg, Va.-based Peanut Corp. of America filed for Chapter 7 bankruptcy in U.S. Bankruptcy Court in Virginia Friday, the latest bad news for the company that has been accused of producing tainted peanut products that may have reached everyone from poor school children to disaster victims.

The Associated Press: Peanut Corp. of America files for bankruptcy

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Technorati Tags: Healthcare,FDA,technology,Congress,Pharma,food poisening,contaminated food,FDA audit trails,peanut butter

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Stem Cells appear to have cured HIV – at least for now there are no visible signs of HIV

Stem Cells are truly miraculous with what can be done with some diseases and health problems becoming a-symptomatic after the procedure.  This procedures was actually very risky and one physician said 1/3 of the patients could die from the procedure as it is shutting down the immune system with the transplant to allow that of the donor to take over.  They also said the HIV virus could be hiding in other areas of the body, but 2 years with no sign is pretty miraculous by all means.   

The related reading below has a multitude of posts on what’s going on with stem cells in many different areas including growing heart valves.    Don’t miss the video from the TED meeting this year as well, amazing stuff with regenerational medicine and will be more coming in the next couple weeks on the topic.  BD   

Regenerative Medicine – Material and Cell Based Regeneration of the Human Body

A 42-year-old HIV patient with leukemia appears to have no detectable HIV in his blood and no symptoms after a stem cell transplant from a donor carrying a gene mutation that confers natural resistance to the virus that causes AIDS, according to a report published Wednesday in the New England Journal of Medicine.

The case was first reported in November, and the new report is the first official publication of the case in a medical journal. Hutter and a team of medical professionals performed the stem cell transplant on the patient, an American living in Germany, to treat the man's leukemia, not the HIV itself.

HIV uses the CCR5 as a co-receptor (in addition to CD4 receptors) to latch on to and ultimately destroy immune system cells. Since the virus can't gain a foothold on cells that lack CCR5, people who have the mutation have natural protection. (There are other, less common HIV strains that use different co-receptors.)

People who inherit one copy of CCR5 delta32 take longer to get sick or develop AIDS if infected with HIV. People with two copies (one from each parent) may not become infected at all. The stem cell donor had two copies.

Man appears free of HIV after stem cell transplant - CNN.com

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Technorati Tags: Stem Cells,healthcare,R and D,Biotech,Clinical Trials,HIV,Blood Cells,Transplant,Cancer

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Steve Ballmer, CEO Microsoft Writes to Congress

This comes after addressing the members of the House of Representatives last week.  Hopefully the lawmakers will get the job done soon!  As we all have heard him speak, it’s “developers, developers, developers”…”nothing happens until someone writes great piece of code”…and we need the “smart” people in key places in government today!

Without the sophistication and intelligence on the side of the government to understand and work with the algorithms created elsewhere, we are in trouble as we have seen in the last couple weeks.  BD

February 11, 2009

Dear Member of Congress:

Microsoft strongly supports passage of the conference agreement announced today between the House and Senate on the American Recovery and Reinvestment Act of 2009 (H.R. 1), and I urge Congress to act now.  We believe the final conference agreement will help families during this difficult economic time, create and save jobs, and begin to put our country back on the path toward long-term economic growth. 

We are experiencing a once-in-a-lifetime economic crisis.  However, this crisis also provides an opportunity to restart the economic engine, shore up our financial institutions, and rebuild investor and consumer confidence.   Investing in people and our nation’s science and technology infrastructure will put us on the right path for the future.

This final package includes significant investments in human capital—in the citizens of our country.  America is second-to-none in turning ideas into innovations.  In today’s knowledge-driven world, innovation depends on workers who are technically sophisticated and have strong critical thinking skills.  To succeed in the knowledge economy, our workers need access to ongoing education and training services.  For the unemployed, new technical skills provide a new start up the economic ladder.  We have to provide lifelong learning opportunities so everyone has the right skills as technology advances and the economy expands.

In the same way, it is critical for the U.S. government to make this long-term commitment to research and development (R&D), and to encourage private sector R&D that will propel our economy forward.  This year alone, despite the tough economy, Microsoft will invest over $9 billion in R&D to help grow our business for the future, drive innovation across the industry, and help keep the U.S. at the forefront of emerging technologies.

The conference agreement includes critical government investment in our nation’s science and technology infrastructure.   These investments will help extend the reach of broadband access to many communities  and improve access for many citizens.   The conference agreement also provides incentives to create jobs in green technology, alternative energy, bioengineering, and advanced computing and technological solutions that will help us address some of our most pressing challenges. 

The agreement also promotes the adoption of information technology to transform healthcare.  We believe information technology can help create a connected health system that delivers predictive, preventive, and personalized care—a system that will improve the health of Americans and help control healthcare spending.  Government support for rapid adoption of information technology is essential and measurable outcomes are needed to help the Administration and Congress achieve the goals of increased access, lower healthcare costs, and improved quality of care. 

I urge you to support the conference agreement and I look forward to working with you as you shape policies that will revitalize our economy and create long-term economic growth.

Sincerely,

Steven A. Ballmer
Chief Executive Officer
Microsoft Corporation

Technorati Tags: Microsoft,Steve Ballmer,healthcare,algorithms,Congress,Stimulus Bill,Economy,Heatlh IT

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Cigna and Aetna face lawsuit – AMA joining the the cause on payment issues

It appears Ingenix is mentioned once more with the legal cases, but those cases are separate but with the same underlying issues of low payments made to the physicians for out of network charges.   We also have the cases of balance billing in California that have also created a lot of havoc and problems for patients as well.  It is a guessing game of sorts, who, what and how much will be paid, and not to mention the flurry of paperwork, time on the phone, etc. that goes along with the processes.  BD 

The American Medical Association is joining several state associations in suing health insurers Cigna Corp., of Philadelphia, and Aetna Inc. over a database they say was rigged to underpay doctors on out-of-network claims for more than a decade.

Doctors want compensation for the time they wasted asking the insurers for more money and for income they lost because of the low payments and the inability of patients to pay their share of the bills, said Lawrence Downs, general counsel for the Medical Society of New Jersey, one of the groups participating in the suit. 

Patients who use doctors who are not in their insurance company's network typically are expected to pay whatever the insurer doesn't. Downs said Cigna and Aetna set their payments too low, leaving patients with a bigger share of the bill.

The lawsuits heap more criticism on data from Ingenix Inc. that already has cost Minnetonka, Minn.-based UnitedHealth Group Inc. $350 million to settle a separate lawsuit involving the AMA.

Cigna and Aetna face suit over payments | Philadelphia Inquirer | 02/11/2009

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California and Balance Billing

The battle of the medical bills where nobody but the insurers win

California sues Prime Healthcare over balance-billing practices

California Supreme Court bans ER 'balance billing'

Prescriptions risk score used to deny health insurance

The 2 New Hot Words in Healthcare: Algorithms and Whistleblowers

Technorati Tags: Health Insurance,HealtHealthCare,fines,overcharges,Inginex,algorithms,formulas,Cigna,AMA,Aetna

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Arizona Data Base for Physicians and Pharmacists to locate the “Doctor Shopping Patients”

So far there seems to be quite a bit of interest in the data base, open to pharmacists and doctors only.  One physician stated he had found one patient who had seen 23 doctors and 18 pharmacies seeking controlled painkillers over an 8 month time frame.

Interesting, is that law enforcement does not have to be notified, in other words it is operating somewhat like a “We Tip” type of service.  A patient can submit a request to view their records though if need be by writing a letter so get a copy of what is on file, that is if they need it, as a precaution as mistakes could be made with cross referencing a name for example, but most of the Doctor Shopping patients and their medications are pretty much know themselves I would guess.  The data base lists drug listed on Schedules II, III or IV of the federal Controlled Substances Act and not other medications that are not under the controlled substance act.  BD

The program, which debuted in December and is overseen by the Arizona State Board of Pharmacy, is designed to cut down on the persistent problem of prescription-drug abuse. But it also has raised concerns among privacy-rights groups that fear computer hackers or unscrupulous health workers will access patients' personal information.

The system, they say, allows physicians and pharmacists to more easily identify "doctor shoppers," people who visit various doctors to obtain drugs that are potentially addictive.

When any Arizona pharmacy or doctor who dispenses medication fills an order for a drug listed on Schedules II, III or IV of the federal Controlled Substances Act, the details are forwarded to the outside contractor that maintains the database and are entered within a week or two. The data include the patient's name, date of birth, prescribing doctor, medication, the date the prescription was filled and the mailing addresses of the pharmacy and patient.

The drugs on the lists include potentially addictive painkillers, sleep aids, medications that contain morphine or certain forms of codeine, and hormone drugs, including steroids.

Doctors and pharmacists must register to access the database. They then can type in the name of a patient requesting a medication to see whether the person had other similar prescriptions filled and when.

Users of prescription drugs being tracked in Arizona

Technorati Tags: prescriptions,drug abuse,controlled substances,heatlhcare,Arizona,pharmacists,physicians,medications

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Michael Moore – New Movie and looking for Wall Street Informers and Whistleblowers

Michael Moore is back in action with another movie in the making, and this time looking for information in the same format as was done for Sicko.  After what we witnessed last week with the SEC, he could have a line forming.  We all know how many charities have been hurt through the recent series of events as well, including many in healthcare.  BD 

“I am in the middle of shooting my next movie and I am looking for a few brave people who work on Wall Street or in the financial industry to come forward and share with me what they know. Based on those who have already contacted me, I believe there are a number of you who know "the real deal" about the abuses that have been happening. You have information that the American people need to hear. I am humbly asking you for a moment of courage, to be a hero and help me expose the biggest swindle in American history.

All correspondence with me will be kept confidential. Your identity will be protected and you will decide to what extent you wish to participate in telling the greatest crime story ever told.

The important thing here is for you to step up as an American and do your duty of shedding some light on this financial collapse. A few good people have already come forward, which leads me to believe there are many more of you out there who know what's going on. Here's your chance to let your fellow citizens in on the truth.”

Welcome to MichaelMoore.com

Hat Tip: Pharmagossip

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SiCKO Health Care Card...

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"Michael Moore, you just saved my home."

PlanetHospital Offers SICKO Viewers an Answer to Their Healthcare Needs: Medical Tourism

"Who's Right about Kaiser -- Michael Moore or SEIU?

Technorati Tags: Michael Moore,Whistleblowers,heatlhcare,Wall Street,economy,Sicko,movie

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Advanced Patient-Centered Cancer Care Goes Digital

In addition to the electronic medical records, an online chat and 24 hour phone line is available.  This can certainly save patients having to bring all their test results from one place to another manually and the educational information could certainly prove to be helpful as well, as this is an area where patients are perhaps not always informed of what their treatment options are, and help explain what treatment plans involve.

There’s also a page that describes various cancer medications on the market and available.

 From the website below:

“What is patient empowerment medicine?

A Patient Empowerment Medicine^SM approach means our doctors offer to educate and empower you and your caregivers to actively and meaningfully participate in your cancer care.

As a patient at CTCA, you will meet with a multidisciplinary team of cancer experts who will explain the role their practice area can play in your treatment. Rather than telling you what you need, your care team will listen to you and provide clear, well-defined choices. Then, they will help you decide on a treatment plan that best suits your individual needs. “

First all-digital cancer hospital enhances commitment to quality care at Cancer Treatment Centers of America

GOODYEAR, Ariz., Feb. 11 /PRNewswire-USNewswire/ -- Cancer Treatment Centers of America (CTCA) has opened the nation's first all-digital cancer hospital in Goodyear, Ariz. The 213,000-square-foot facility is the fourth hospital in the steadily growing CTCA network.

CTCA at Western Regional Medical Center (Western) extends the comprehensive electronic health record (EHR) system launched by CTCA last year. The CTCA EHR is designed specifically to support the unique patient-centered care model found only at CTCA hospitals. CTCA offers cancer patients a fully integrative cancer treatment experience that combines traditional, state-of-the-art medical treatments with scientifically supported complementary therapies.

"Western is the first cancer hospital in the nation to offer a fully digital environment," said Edgar D. Staren, M.D., Ph.D., MBA, senior vice president for clinical affairs and chief medical officer at CTCA. "Our other three hospitals in suburban Chicago, Philadelphia and Tulsa are rapidly approaching fully digital status as well.

Fully "wired" from the ground up, Western opened its doors in December with a fully electronic health record, all systems integrated into the core EHR, and all providers able to contribute to the continuity of care document. Those familiar with the Healthcare Information and Management Systems Society (HIMSS) Analytics EMR Adoption Model(SM) will recognize the level of automation as "Stage 7" or all digital.

Electronic Health Record Advances Patient-Centered Cancer Care

Technorati Tags: EHR,EMR,cancer,Cancer treatment,healthcare,technology,chemotherapy,empowerment medicine

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Allscripts-Misys Stock Repurchase and Larger Credit line

The Allscripts-Misys group was hit with the Wall Street crisis as well and has had to work on financing issues as changes occurred.   It appears the core focus now with the company will be in the area of Health IT.  BD 

The Chicago-based company, formed by a merger in 2008, has approved a repurchase program for up to $150 million in common stock over the next two years.

It also has entered a new agreement with JPMorgan Chase Bank to increase its credit line by $50 million to $125 million and add Fifth Third Bank as syndication agent and co-lead arranger. Under the terms, the credit line may be expanded by another $25 million later.

The company also announced the pending sale of its medication services unit to an unnamed firm. The unit sells prepackaged medications and provides point-of-care medication management and medical supply services.

Allscripts-Misys Makes Moves

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Technorati Tags: CahRHIO,medical records,information interchange,integration,Allscripts,Misys,healthcare,EMR,EHR,IPA,Kaiser Permanente,RHIO

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Medicare Projects did not save money overall

People did learn healthier habits and lifestyles, so not all was in vain, but the big paybacks seemed to be non existent.  BD 

Most of the patients had serious, but common, age-related illnesses including diabetes, heart disease and lung disease. Programs were set up at 15 centers around the country. Only two cut the number of times these patients were hospitalized, and those are still in operation. None saved Medicare any money.

The authors of the study called the results "underwhelming." An editorial in the Journal of the American Medical Association, where the study appears Wednesday, used the term "sobering."

Sobering results for cost-cutting Medicare project - washingtonpost.com

Technorati Tags: Medicare

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Patrick Swayze Writes to Congress – give the NIH the Funds they need

This was published in the Washington Post.  Use the link below to read the entire letter.  We need the research dollars and grants to cure cancer, I agree.  BD

I'm Battling Cancer. How About Some Help, Congress?  By Patrick Swayze

For me, fighting cancer is personal. Ever since I was diagnosed with pancreatic cancer in January 2008, I've been waging an intense, often hellacious battle. It's me (with a lot of love and medical support) against my disease.

But I'm not alone. More than 1.4 million Americans will be diagnosed with cancer this year. In the United States, one out of three women and one out of two men will be diagnosed with cancer in their lifetimes. Look around you; at one point or another, cancer will strike very close to home for everyone. Last week, it struck one of our legal titans, Supreme Court Justice Ruth Bader Ginsburg, who underwent surgery at the Memorial Sloan-Kettering Cancer Center in New York after being diagnosed with pancreatic cancer during a routine checkup. She was already a colon cancer survivor. Both of us hope to be pancreatic cancer survivors, too.

Our individual battles should also be national ones. With Congress about to decide how much money to include for medical research as part of the economic stimulus package, the time has come to take my personal fight to a larger stage. My message to our senators and representatives is simple: Vote for the maximum funding to let the National Institutes of Health fight cancer and other life-threatening illnesses. It's not only good for our nation's health; it's also good for our economic well-being.

So here's my plea to Congress: Stand up to cancer. Stand up for people fighting serious disease. Stand up and help restore America's economy. Stand up and help build a prosperous and healthy future for our people by giving the NIH $10 billion for research. Stand up to create jobs, fight illness and deliver hope.

swayzewashingtonpost@gmail.com

I'm Battling Cancer. How About Some Help, Congress? - washingtonpost.com

Technorati Tags: Cancer,NIH,R and D,cancer research,grants,healthcare,Congress Stimulus bill

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Limbaugh Worrying about his Medical Records

Well, first of all a lot of his information has been made public by the news in the last few years, but I guess he’s worried about more slipping out there.  I don’t think Rush needs to be as concerned about the software as perhaps he might be about his own activities and how the other information got out there to begin with. 

He further got it wrong suggesting there would be one big data base, which is not the business plan at all, the plan is to make current systems communicate and interchange information.  In a related story today, medical records were taken from a doctor’s car that belonged at the hospital, so go figure that one.  What were those paper charts doing in the car, also being they were paper, is there a back up?  Electronic records are backed up.  Education of all citizens is still one big chore that needs to begin soon and maybe we can start with Rush.  BD 

As the Senate prepares to vote on its paired down version of the recovery package, Rush Limbaugh is still inventing reasons to oppose its passage. Today on his radio show, Limbaugh zeroed in on a $20 billion portion of the bill devoted to increasing the use of health care IT. Limbaugh warned, “Your medical treatments will be tracked electronically by a federal system” and declared that this and similar health care provisions have “nothing to do with stimulus but have everything to do with advancing the liberal agenda”:

Think Progress » Limbaugh Opposes Health IT Provisions, Fears His Medical Records Might Become Public

Technorati Tags: healthcare,stimulus Bill,Rush Limbaugh,medical records

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Cancer Cells Viewed in 3D – CT-Cell Microscope

More new technology to help diagnose cancer cells.  The microscope that can use both traditional and fluorescent stains, which is a first.  The error rate for detection was reduced by a third from those using the technique. 

Also, it can also allow for the detection of pre-cancer cells, which I consider to potentially have a big impact as far as early detection goes.  It is still under investigation use and not yet approved by the FDA.  BD 

“VisionGate’s Cell-CT platform produces high resolution 3D information for automated analysis of intact cells. Cells are injected into a capillary tube that rotates to allow image capture at multiple viewing angles to compute the internal 3D structure, thus enabling spatially defined densitometry of labeled molecular species and nuclear chromatin.”

“The patient is immobile while the X-ray machine rotates. In the Cell-CT microscope, each cell is embedded in a special gel inside a glass tube that rotates in front of a fixed camera that takes many pictures per rotation. The gel has similar optical properties to the tube's so that no light reflects off the glass. In both processes, the end result is that hundreds of pictures are assembled to form a 3-D image that can be viewed and rotated on a computer screen.”

University of Washington researchers have helped develop a new kind of microscope to visualize cells in three dimensions, an advance  that could bring great progress in the field of early cancer detection. The technique could also bridge a widening gap between cutting-edge imaging techniques used in research and clinical practices, researchers said.

Eric Seibel, a UW mechanical engineering associate professor, and his colleagues have worked in collaboration with VisionGate, Inc., a privately held company in Gig Harbor, Wash., that holds the patents on the technology. The machine works by rotating the cell under the microscope lens and taking hundreds of pictures per rotation, and then digitally combining them to form a single 3-D image.

"It's a lot easier to spot a misshapen cell if you can see it from all sides," Seibel said. "A 2-D representation of a 3-D object is never perfectly accurate - imagine trying to get an exact picture of the moon, seeing only one side."

Cancer diagnosis: Now in 3-D (Video)

Technorati Tags: Cancer,Microscope,healthcare,technology

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FDA Finds ‘Natural’ Diet Pills Containing Drugs

Problems seem to keep coming up with drugs and consumables.  I have a suggestion that can be found at the link below.

FDA May Need Major Restructuring – Catch up with Technology

Basically we need to monitor all consumables with a bank of servers that report in and can notify of any food or drug substance out of tolerance to include factories here and overseas.  It’s not 100%, but it will certainly make it difficult to not comply and warnings would be issued to both the FDA and factory.  FDA agents could follow up immediately in person if needed.  Progress won’t be made without some technology and business intelligence in place.  BD  

Grady Jackson, a defensive tackle with the Atlanta Falcons, said he used the weight-loss capsules. Kathie Lee Gifford was enthusiastic about them on the “Today” show. Retailers like GNC and the Vitamin Shoppe sold them, no prescription required.

But the Food and Drug Administration now says those weight-loss capsules, called StarCaps and promoted as natural dietary supplements using papaya, could be hazardous to your health. In violation of the law, the agency has found, the capsules also contained a potent pharmaceutical drug called bumetanide which can have serious side effects.

And StarCaps are not the only culprits. In a continuing investigation that has prompted consumer warnings and recalls by some distributors, the F.D.A. has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs. In the coming weeks, the agency plans to issue a longer list of brands to avoid that are spiked with drugs, an F.D.A. spokeswoman said.

F.D.A. Finds ‘Natural’ Diet Pills Spiked With Drugs - NYTimes.com

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Business Intelligence for the FDA on the way

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

Technorati Tags: Healthcare,FDA,technology,Congress,Pharma,food poisening,contaminated food,FDA audit trails

 

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Medical Quack on the Web this Week – Feb. 9, 2008

Thanks again to everyone who stops by and send a friend.  Here’s a few updates with some of the post featured on some major publications.

Keep posted as I have some real dynamite interviews coming up in the next couple weeks as well!  BD 

Technorati Tags: Medical Quack,Fox News,Chicago Sun Times

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Proxense RFID and Encrypted Biometric Tracking for Hospitals and more…

Last week I had the opportunity to talk with Matt Davio from Proxense, a new RFID/Biometric solution provider. Their product line can not only track assets, but also patients and clinicians. Proxense has it’s own server to work with present day EHR charting systems.

At the end of the post, there is an excellent video that goes though the entire process with some nice visuals of the processes at work.

Overall the company has 32 patents in place for it’s technology. The RFID tracking is using proprietary frequency. The company is also looking to partner with EHR vendors to enhance currently security. I asked about something I thought was similar a few years ago with a company that offered the ability to pay by biometric fingerprint and Matt told me this is not the same as the biometric information is stored and encrypted on the device and not stored on a server, as was the case with the other technology I had remembered.

St. Charles hospital in Bend, Oregon has signed on to serve a the beta testing facility for the entire network. Initially 3 components will be installed and 2 others added later. The small device, a PDK, (personal data key) which could be in several formats, a card, fob, etc. is called the PROX. It contains the encrypted information. If it is lost, nobody else can access the information as it is tied to your fingerprint. The chip is also secure, in other words, if it is in any way opened, the chip is broken, and useless to the hacker to obtain any encrypted information stored.

The PDK is battery operated.

“The PROX holds ID information, medical records data, and more, and provide a simple and efficient interface for systems and records access. The product has many solutions somewhat built in to one system.”

First of all and probably of most interest to physicians is the solving of the “single sign” on issue. In other words when configured, the physician is automatically logged on to the system, no more having to remember all those passwords, just be in the proximity of the sensors.

Matt also informed me that there are also other uses outside of healthcare for the product, such as a contract recently secured with Bally. Soon, through the technology, we will have a “smart” slot machine that will remember your game preferences and recognize you when you approach the machine. In essence, Matt stated the technology of course has immediate use with healthcare, but is not limited to the industry and other variations are certainly open to discuss.

The solution sounds pretty solid as the Pentagon is also starting a beta project with Proxense in late summer or early fall, and we all know how important security is at the Pentagon.

The visuals in the system are enhanced with the use of Windows Presentation Foundation and the communication system is utilizing technology from Windows Communication Foundation. The links below give some information regarding the technology and more information can be found at Microsoft as well.

• Windows Presentation Foundation (WPF)
• Windows Communication Foundation (WCF)

McKesson is the system used currently at the Bend, Oregon hospital and it require a small bit of modification to interface with ProxMed. Proxense is providing the bridgework for the EHR system through out the facilities.

Additionally down the road, plans have been discussed to link with Allscripts and eClinicalWorks systems to handle connecting the ambulatory EHR systems in use at physicians' offices to the hospital.

Next is the PHR connection with the ProxRec module for the PHR connection. The hospital builds the API connection to work with the Proxense Server to synch to a PHR.

“This module defines a very progressive records storage and access model, providing the plumbing needed to enable Central Records Storage/Access (CRSA) systems such as Microsoft HealthVault and Google Health.”

The auto display automatically pulls the correct chart and logs in the physician in the examining room, for example. This I would see as a huge times saver for the doctors not having to log in each time and also it would ensure the correct chart is on the screen.

The Prox key can also serve as secure access for the patient to their PHR. One a patient is established, whether it be at the hospital or at one of the connected facilities, they are recognized throughout the entire system, so in other words, the biometric log on can be used in each facility, thus eliminating duplication of effort with writing and entering the same data at multiple healthcare facilities.

After speaking with Matt and learning about Proxense, it certainly appears the product stands to not only bridge information, but also add the desired security we all want with our medical records. For one, as a patient, I could certainly appreciate not having to fill in the same information over and over.

With the availability of recent tests for each patient from various facilities, this could also stand to cut down not only time in having the information, but the cost and inconvenience to the patient sometimes of manually having to take the information from one facility to another as well. Hopefully we will be hearing more on the progress being made with the product as it grows.

Thanks Matt for taking some time to explain Proxense and sharing some additional details on how the security, convenience, and PDKs all come together for very complete solution. BD

Related Reading:

http://www.transformationenablers.com/blog/archives/2009/01/startup_hopes_i.html

Technorati Tags: Proxense,RFID,Biometric,Security,Single Sign On,hospital,Security Server,Prox,PHR,EHR,medical records,date encryption,PDK,personal digital keys

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