Pulse on Health by Jeff Hansel

Rare illness? NIH creating list of approved drugs....

The National Institutes of Health (NIH) has "begun screening the first definitive collection of thousands of approved drugs for clinical use against rare and neglected diseases."

"They are hunting for additional uses of the drugs hoping to find off-label therapies for some of the 6,000 rare diseases that afflict 25 million Americans," says an announcement from the NIH.

The federal government's Chemical Genomic Center is coordinating the effort.

Rare diseases often don't get the attention they would if more people (and thus, more advocates) were affected.

The NIH, led by Dr. Francis Collins, is working to find ways to use already-approved drugs in new ways because it's much easier to go ahead an make use of a drug that's already been through the safety-approval process. Each of the already-marketed drugs is a known entity, with known side effects and known safety guidelines.

"The current focus is on collaborating with disease foundations, industry and academic investigators with disease-relevant assays to screen against the approved drug collection…," the NIH reports. Any new use of an already-approved drug would need confirmatory studies.

Still, years could be cut from the developmental process if drugs are already being used to treat another condition and are coincidentally found to help in the treatment of a rare disease.

"Creating a new drug is expensive," the NIH says. "Recouping the investment can be difficult for rare diseases, due to the small number of patients with the disease or, in the case of tropical neglected diseases, the limited ability of patients to pay for treatments."

Thalidomide, which caused birth defects when pregnant women took it for morning sickness, was "repurposed" for use as a treatment against leprosy and for multiple myeloma patients, the NIH reports. 

The NIH also plans to screen existing drugs to determine their toxicity.

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Minnesota needs better drug supply... #RochMN

Minnesotans are being directly affected by apparently widening shortages of prescription drugs to treat cancer, mental illness and other disorders.

We've previously reported about shortages of chemotherapy drugs that have few effective alternatives and are in such short supply that medical centers are calling each other, and shuffling back and forth within their own systems, to keep patients supplied.

Even Mayo Clinic here in Rochester, Minnesota has struggled to keep patients supplied with some essential chemotherapy drugs. I recently received a report of an individual who was just days away from her scheduled treatment, but the one drug shown effective for treating her cancer was not available. 

Now, U.S. Senator Amy Klobuchar, D-Minnesota, is asking a specific drug maker of a drug to treat ADHD to "properly stock supply chain to avoid future shortages."

"U.S. Senator Amy Klobuchar today urged Shire Pharmaceuticals, the manufacturer of a prescription drug commonly used to treat attention-deficit hyperactivity disorder (ADHD) in children, to take immediate action to address the shortage of the drug in Minnesota," says an announcement from the senator's office. "The disruption in the available supply of the ADHD drug treatment, both Adderall XL and its generic version, has left Minnesota hospitals and pharmacies – including Children's Hospitals and Clinics and Allina Community Pharmacies – unable to fill prescriptions, forcing Minnesota patients to pay for more expensive brand-name drugs or switch to less effective treatments."

As anyone who has a chronic health condition knows, switching to a different drug has immediate and sometimes long-term effects. It can take time to get "used to" a different medicine, even if it's only slightly different.

Here is the full text of Klobuchar's letter, as provided by her office:

 

Dear Mr. Russell,

I am writing about a growing problem caused by the lack of availability of the generic version of Adderall XL, manufactured by Shire Pharmaceuticals, that is used to treat attention deficit hyperactivity disorder (ADHD). As you know, Minnesota is a leader in providing high-quality health care, especially when it comes to ensuring the well-being of our public health. However, due to this shortage several Minnesota hospitals and pharmacies are having difficulties filling prescriptions for these products. I urge you to take immediate action to address this shortage so that Minnesota patients, particularly children, can continue to have access to this vital medication.

Attention deficit hyperactivity disorder is the most commonly diagnosed behavioral disorder during childhood and often results in inattentiveness, over-activity, impulsivity, or a combination. It affects approximately 5.4 million children between the ages of 4 and 7 with the rate of diagnosis increasing each year. Children with a history of ADHD are almost 10 times as likely to have difficulties that impact their peer-to-peer relationships.  To ensure that all children are safe and have every opportunity to succeed, it is vital that all forms of treatment and medication be available.

Due to a nationwide ADHD drug shortage, pharmacies are finding it difficult to fill prescriptions for generic version of ADHD drugs.  Patients are being forced to purchase more expensive brand-name products or switch to less optimal alternatives. Because Shire Pharmaceuticals produces both brand and generic versions of Adderall XL, I urge you to work with the FDA, distributors, hospitals, and patients to ensure the supply chain is properly stocked.

While it has been reported that this shortage may be resolved in the coming weeks, I am hopeful that you can provide information to clarify what specific factors have led to this particular shortage, what actions your company has taken and is taking to address this problem, and how we can work together to prevent these disturbances from recurring.

I have introduced legislation that would include reporting requirements that will help address drug shortages, but I hope to work with the FDA, companies like Shire Pharmaceuticals, and with hospitals and consumers to develop comprehensive plans that will prevent shortages in the future.                                                                         

I look forward to working with you on this important issue.

Sincerely,

Amy Klobuchar

United States Senator

 

 

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Proton therapy, bursting at the seams... #RochMN #cancertreatment

Check out the print edition of the Post-Bulletin starting Saturday (April 30, 2011) for coverage of proton beam cancer therapy.

My hope is that you'll take a look at articles scheduled for publication this weekend, Monday and Tuesday. By the time you're through, I think you'll have a pretty good sense of what proton therapy is.

Mayo Clinic is planning to build a $200 million facility here in Rochester, Minnesota to offer a special type of proton therapy called "pencil beam." That type electronically targets cancerous tumors.

We want to give you a real sense for what proton therapy is, since it's a little hard to imagine without visiting the only place in the U.S. to offer pencil beam — MD Anderson Cancer Center in Houston, Texas.

If you've ever had a cancerous tumor, you'll understand that traditional radiation can inflict damage to surrounding tissues. But pencil beam sends protons directly to a tumor, largely avoiding damage to surrounding tissue (and risk of treatment-related cancers later).

Please take a look at our coverage and let us know what you think.

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Alzheimer's Association heads to Goonie's....

The Alzheimer's Association in Rochester, Minnesota plans a fundraiser revolving around humor.

Date: Tuesday, May 3 (2011)

Time: 6 p.m.

Cost: $45

Includes: Dinner served at 6 p.m. and comedy starting at 7 p.m.

Location: Goonie's Comedy Club, 7 Second St. S.W., Rochester.

"Enjoy Food, Fun, and Laughter while supporting the Alzheimer’s Association," says the Rochester Downtown Alliance.

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Discoveries at Mayo Clinic are owned by Mayo... #RochMN

A district court decision means Mayo Clinic must pay Dr. Peter Elkin royalties. But Mayo is indeed the owner of the discovery made in Elkin's research lab while he worked at Mayo.

"Prior to the jury returning its verdict, the Honorable Judge David S. Doty ruled that Mayo Clinic was the sole owner of software developed by Dr. Elkin during his 12 year tenure at Mayo," says a blog post by Mayo Spokesperson Karl Oestreich. "In addition, the jury determined that Dr. Elkin breached Mayo’s employment policies by taking Mayo’s software without authority, that he intentionally interfered with Mayo’s business relationship with Cerner Corporation and that Dr. Elkin willfully and maliciously misappropriated Mayo’s trade secrets."

So, in other words, if you discover something at Mayo, you get a cut of the financial benefit. But Mayo owns the technology you develop and gets to keep the bulk of the money.

Obviously, researchers need the resources to conduct studies and Mayo's laboratory space and financing of staff come in handy in that regard.

So it's hard for a scientist to progress without the likes of Mayo. But it's also true that Mayo relies upon keeping intellectual property in its own control.

Oestreich quotes Steve Van Nurden, chair of the Mayo Office of Intellectual Property, as saying, "while all intellectual property created by employees during their employment at Mayo Clinic is the property of Mayo, our royalty sharing policy rewards employees for their ideas by paying them a portion of net income generated as a result of the successful commercialization of their technology."

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Olmsted Medical Center Foundation goes public.... #RochMN

The 2011 Noel R. Peterson Founders Lecture will be free and open to the public, says an announcement from host Olmsted Medical Center Foundation.

The guest lecturer this year is Dr. Val Ulstad, "cardiologist, educator and Minnesota Council of Nonprofits senior fellow."

According to a description of the planned event, Ulstad will tell the audience that they are the leaders we all hope for.

The description says "adaptive leadership helps map the territory of human behavior, describing what people do and how they behave in groups. More importantly, it reveals what people exercising leadership can do with some deeper understanding of fear and resistance to change."

Lecture title: "Exercising Leadership: We are the Ones We Have Been Waiting For"

Time: 5:30 p.m. reception (lecture at 6 p.m.)

Date: Thursday, May 19

Location: Doubletree hotel, 150 S. Broadway, Rochester, Minnesota

Cost: Free (light fare of soup and salad offered)

Seating is limited: RSVP by May 13, 2011 to foundation@olmmed.org. 

Questions? Call Michelle Maeder-Hickey, 292-7202

The sixth of the lecture, started through a gift from Dr. Noel and Ann Peterson in 2006, promises to be another popular events. Previous lectures have drawn large crowds. 

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Hear those steam shovels cranking....? #RochMN

The Arizona Republic is reporting that Mayo Clinic plans to add a tower to the Mayo hospital in Phoenix, Arizona. 

"The facility, 5777 E. Mayo Blvd., already has city permission to expand, and the new building could be the base of a new hospital tower. Mayo has been at the site, near 56th Street and Loop 101 in northeast Phoenix, since 1998," Republic reporter Michael Clancy wrote Saturday (April 23, 2011). 

It's unclear from the report when construction for the 14-floor hospital tower will actually begin. But Mayo apparently is planning to create an entryway for that new wing of the hospital (in conjunction with the $200 million proton therapy construction on the Phoenix campus).

"The building would have two floors below grade with small elements above grade, including an entry pavilion and a loading dock," Clancy writes. "In the future, this building could expand as a tower of 14 floors for examination rooms and doctors' offices."

It's getting so I'm having a hard time keeping up myself with all of Mayo's current construction projects:

• Jacksonville, Florida: $15 million simulation center.

• Phoenix, Arizona: Conference center, hospital tower(?), hospital tower entryway and $200 million proton beam cancer-therapy center.

• Austin, Minnesota: $28 million addition of an 85,600-square-foot building "to make it easier for patients of the community to receive care closer to home."

• Rochester, Minnesota: $200 million for the new proton cancer-therapy building and shell space for Rochester Methodist Hospital expansion, $33 million for Mary Brigh Building surgery-center expansion at Saint Marys Hospital, $25.8 million for emergency department renovation and expansion at Saint Marys Hospital.

• Eau Claire, Wisconsin: $6.9 million to expand the Luther Midelfort Northland Emergency Department.

• Northfield, Minnesota: $10 million for a cancer treatment center.

Clancy also notes in his article that Mayo in Phoenix plans a 7,000-square-foot conference center for classroom space and meetings.

Yes, folks, that's more than $500 million in current construction projects by Mayo Clinic alone nationwide — and it doesn't count whatever Mayo plans to do in terms of construction for the Mayo Clinic Gateway at the Mall of America, which mall officials have likened to construction of a Radisson Blu hotel. I wonder, too, whether there are construction projects that I've neglected to include in the list!

Also, here in Rochester, construction remains underway on Olmsted Medical Center's $13.8 million Northwest Clinic.

So if you're worried about job openings, the Great Recession and other issues, my glass-half-full attitude is that the economy will get a pretty good boost out of Mayo and OMC's nearly $300 million worth of construction projects either already underway, in the planning process or expected to begin construction in the next year in Rochester and Austin alone.

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

More Mayo Clinic construction.... #RochMN

Watch this weekend's Post-Bulletin for coverage of cancer-fighting pencil beam proton therapy Mayo Clinic plans to install here in Rochester, Minnesota.

Articles about the Proton Therapy Center at MD Anderson Cancer Center in Houston, Texas are forthcoming after my return from visiting there. We want to help you see what pencil beam therapy is all about, because Mayo Clinic plans to invest about $200 million here in Rochester.

Separately, Mayo announced today that it will build a $15 million simulation center on its Jacksonville, Florida campus to train medical personnel with simulations that mimic real-life situations without the risk of patient injury. The clinic announced, also, a fundraising project, with a goal of starting construction before the end of 2011 if enough funds are raised by then.

The simulation center in Florida will be electronically connected to the ones at Mayo in Rochester and Phoenix, Arizona.

"Ruthe and Nathanial Leek helped create some of Mayo Clinic in Florida's most life-affirming places and programs, including the family birth center at Mayo's former hospital in Jacksonville, the Leek Gallery at the San Pablo Road campus and the Mayo Clinic Humanities in Medicine Program," says an announcement from Mayo in Jacksonville. "Now, the couple's estate is continuing that tradition, providing $1.7 million for a simulation center that will benefit present and future generations by enhancing the quality, safety and affordability of patient care."

Mayo's aggressive construction schedule includes an update to the Saint Marys Hospital ER in Rochester, an expansion of the Mary Brigh surgical center at Saint Marys, the proton beam center in Rochester with expansion-ready shell space for Rochester Methodist Hospital; a second pencil beam center in Phoenix; and, now, the simulation center in Jacksonville. 

Don't forget Mayo's cancer center being constructed in Northfield, Minnesota and the as-yet-undisclosed amount of money to be spent at the Mall of America in Bloomington for the Mayo Clinic Gateway at the Mall of America. 

Mayo officials obviously feel their pursestrings are less worrisome than they were just a couple of years ago, when the clinic was pinching every penny to turn its break-even financial performance around.

Now the nearly $8 billion non-profit has the ability to invest in the communities it serves, and it's taking advantage of that opportunity.

The financial impact in communities like Austin, Minnesota (where Austin Medical Center-Mayo Health System is getting a makeover); Rochester, Jacksonville, Phoenix, Bloomington, Northfield and elsewhere is sure to give locals a positive outlook for their economies.

Here's a shout out to the Mayo folks in Jacksonville, who can expect a whole new system of medical education. Mannequins will be used to simulate trauma cases. Actors will mimic the emotional impact when a physician must, inevitably, announce that a patient has not survived. 

We've witnessed that activity at the Mayo Clinic Multi-disciplinary Simulation Center here in Rochester. Now it's coming to Jacksonville too.

Key to many of Mayo's construction projects are philanthropic gifts, such as the one from Richard O. Jacobson, who gave $100 million toward the proton center in Rochester.

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Creating photosynthetic creatures....?

Researchers at Harvard Medical School say they have successfully injected photosynthetic cells into zebra fish embryos without injury to the developing organisms, "a first step toward inducing photosynthesis in new life forms."

An article titled "Toward a Synthetic Chloroplast" was published in the open-access scientific journal PLoS ONE this week (April 20, 2011).

"The zebrafish cells divided normally, and the cyanobacteria survived until pigments in the developing embryos began to block light," an announcement from the medical school says.

If successful, the researchers hope to use the knowledge for growing "designer molecules such as nutrients, medicines and biofuels." They report that a naturally-occurring example of the same phenomenon was discovered by Canadian researchers in the wild in salamanders hosting algae that disappear as their embryos turn opaque. 

The researchers are quoted as saying that cyanobactera have "great potential as synthetic biological devices."

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel

Living longer because of cleaner air....?

Scientific American says U.S. residents of major cities like Philadelphia live longer because of air-quality controls put in place to protect public health during the 1970s.

"…when fine-particle air pollution dropped by 10 micrograms per cubic meter, life expectancy rose by 31 weeks…," says a Scientific American blog post, describing a 2009 New England Journal of Medicine study of metropolitan dwellers.

"Where fine particle counts dropped even more—by 13 to 14 micrograms, such as in New York City, Buffalo and Pittsburgh—people lived some 43 weeks longer on average," Scientific American says. That's nearly a year of extra life.

Often, there's a focus in medicine on treating individual health problems. But quality of life can be improved and lifespan increased on a much broader scale by taking actions such as providing clean, publicly available drinking water; pasteurizing milk and decreasing the amount of pollutants put into the air.

According to the Minnesota Pollution Control Agency, "recently released maps developed using satellite-derived remote sensing show Minnesota to have some of the lowest concentrations of fine particle pollution in the United States."

Importantly, "still, levels of fine particles and other pollutants are elevated in the Twin Cities metropolitan area and other Minnesota cities. Researchers continue to find serious health effects at ever lower levels of air pollution."

Much of the pollutants in Minnesota air (like nitrogen oxides, sulfur dioxides, volatile organic compounds and fine particulates) come from "burning fuel in vehicles, off-road equipment, electric utilities, and other industrial and residential sources," the MPCA says. 

Pulse on Health
By Jeff Hansel, member Association of Health Care Journalists
Health Reporter for the Post-Bulletin newspaper, 18 1st Ave. S.E. in Rochester, Minnesota 55904 
Twitter Hansel's Pulse: @Jeff Hansel