Blind Shopping. Hip Replacement Costs.

Hip surgery prices hard to obtain:study

By Melanie Evans   Modern Healthcare    FiDA highlight

Posted: February 11, 2013 - 12:01 am ET

Hip replacement surgery prices varied by more than $110,000 across the U.S.—at least, for hospitals and physician offices that provided prices when asked, a newly published survey shows.

Not all hospitals surveyed provided prices, and among those that did, not all could quote the price for hospital and physician fees, and some did so only after repeated phone calls, researchers wrote in Journal of the American Medical Association Internal Medicine online.

“Obtaining pricing information was difficult and frequently required multiple conversations with numerous staff members at each hospital as well as affiliated physician offices,” the study said. More than one-fourth of hospitals didn't quote a price until at least the third call. (Researchers called up to five times for a price.) Often, hospital employees were confused, uncertain and did not return messages, the authors wrote. “It is sobering to compare our experience with the best practices we have come to expect from other service industries.”

Meanwhile, prices “varied nearly 10-fold across hospitals” despite a standardized request. The total price, including hospital and physician fees, ranged from $12,500 to $105,000 among the top-ranked hospitals and $11,100 and $125,798 among randomly selected U.S. hospitals.

Researchers called two randomly selected hospitals in each state plus the U.S. News and World Report top 20 hospitals for orthopedic surgery. Hospitals were asked for the lowest price, including physician fees, for a hip replacement for a 62-year-old woman with no other conditions and no insurance.

Prices may have varied depending on whether hospitals quoted the sticker price or offered a discount or because of amenities or other differences, the authors said.

Nineteen hospitals, including nine top-ranked hospitals, quoted researchers a bundled price for hospital and physician services.

Another 19 hospitals failed to provide any prices, including three top-ranked hospitals. Some hospital patients must first see a doctor. Others said prices could not be provided over the phone. And some said “they had no way to provide such an estimate,” the authors wrote.

Another 57 hospitals and physician offices provided prices separately, which allowed researchers to come up with an estimated price.

Researchers obtained a partial price for the remaining hospitals.

Hospitals may have not responded to the push for price transparency by policymakers and health insurers, which have increased the financial incentives for households to shop around, the researchers wrote.

Last year, one-quarter of U.S. workers were covered by health plans with a deductible of at least $1,000, compared with 6% of workers six years ago, according to the Kaiser Family Foundation. Some health plans now cover surgery with a lump sum, known as a fixed-dollar contribution; patients must pay the difference between the insurance payment and the price of surgery.

“Our results suggest that such efforts at pricing transparency have not been well integrated into the operations at many hospitals,” the paper said.

Read more: Hip surgery prices hard to obtain: study | Modern Healthcare http://www.modernhealthcare.com/article/20130211/NEWS/302119966#ixzz2KcH8gywe

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Knowingly implant a failed medical device for profit.

New York Times     EDITORIAL

What a Company Knew About Its Metal Hips

Published: February 10, 2013   FiDA Highlight

                                   

All-metal hip replacements have failed at a high rate and harmed many patients in recent years. Now there is evidence that a major manufacturer was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.

The all-metal hips, in which a ball and a cup component are both made of metal, were thought to be superior in some respects to traditional hip replacements made of plastic and metal. Some 500,000 people in this country received all-metal devices over the past decade. They were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close, and began failing not long after implantation.

Thousands of patients have had to replace them in painful operations; hundreds more have suffered internal damage. Court documents now show that a major manufacturer, the DePuy Orthopaedics division of Johnson & Johnson, buried the bad news about a model known as the Articular Surface Replacement, the most failure-prone of the implants. The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.

Surgeons have largely stopped using the device; even so, the company is facing more than 10,000 lawsuits in this country related to past implantations. Though the company says the evidence will ultimately show that it acted appropriately, it clearly has a lot of explaining t

U.S. Patient Advocates: Ben Goldacre is here!

Some talks in the US and Canada. COME!

January 30th, 2013 by Ben Goldacre in bad science | No Comments »

Bad Pharma is out in the US and Canada on 5th Feb, which is extremely good news (sorry about the delay, floods and hurricanes apparently..). I’ll be doing a few public lectures in various places, alongside media stuff and other things, there’s a list of open ones below.

If you’re a US podcaster or blogger and you want to chat about bad behaviour in the pharma industry then do please email the three of us (Brian.Gittis@fsgbooks.comben@badscience.net zross@unitedagents.co.uk).

Also: in the UK I’ve done a gazillion talks, and the most fun things always come from random people. So if from the list below it looks like I’m passing through your town and you want me to do a talk in your university, a pub, or an event, or you think there’s someone I should meet, a campaigner, an academic, a journalist, then please contact jglover@randomhouse.com for Canada, and Brian.Gittis@fsgbooks.com for the US. Do also cc me, ben@badscience.net, and we’ll try to fit it in around the various bits of other work while I’m out there.

Cheers!

You can buy the US edition of Bad Pharma here.

PORTLAND, OR
Sun 17th Feb 7:30pm
Powell’s Bookstore, 1005 West Burnside.
Talk, Q&A, and signing

www.powells.com/locations/powells-city-of-books/

SEATTLE, WA
Mon 18th Feb 7:30pm
Town Hall, downstairs, enter on Seneca Street
Talk, Q&A, and signing:

townhallseattle.org/ben-goldacre-how-drug-companies-mislead-doctors-harm-patients/

NEW YORK CITY, NY
Thurs 21st Feb 7:00pm
Talk, Q&A, and signing
NYC Skeptics at University Settlement, 184 Eldridge Street

nycskeptics.org/events/rationally-speaking-podcast-live-with-guest-ben-goldacre.html

TORONTO, CANADA
Friday, 15th Feb, 7:30pm
Massey College lecture, free and open to the public.

www.masseycollege.ca

MN Congressman Erik Paulsen Follows the Money

Erik Paulsen pushes medical device tax repealwhile getting megabucks from medical industry

By Aaron Rupar Fri., Feb. 8 2013 at 1:42 PM  FiDA highlight

On Wednesday, Republican U.S. Rep. Erik Paulsen introduced a bill to repeal the medical device tax included in Obamacare. In 2012, by a wide margin, Paulsen led the House in money received from medical supply companies.

Following the money suggests there's more to Paulsen's medical device tax view than a concern about stifling economic activity.

Seems like there's probably a connection between those two things, right? But Paulsen denies it.

Asked today by the Star Tribune whether the $110,100 he received from the medical supply industry last year plays a role in his interest in the medical device tax, Paulsen said: "No, none whatsoever." It's unclear whether his nose grew as he uttered those words.

Paulsen's push to repeal the tax is also supported by Amy Klobuchar and Al Franken, and guess what? Last year, Klobuchar received the third most money from medical supply companies of any Senator ($90,025); Franken clocked in at 12th ($30,349).

Of course, we're not exactly breaking news by suggesting financial contributions play a role what legislation various elected officials support. To take just one additional example, around this time last year, Klobuchar and Franken both supported anti-piracy legislation that would've benefited big media. And as we reported, both senators received hundreds of thousands of dollars from big media companies in the preceding years.

Last  year, Paulsen wanted to make up for the $29 billion that would be lost if the device tax were repealed by reducing health care subsidies for the poor. But as you'd imagine, that proposal wasn't popular with Democrats, and this year's bill doesn't specify what would make up for the lost revenue.

 Read my blog:  Failed Implant Device Alliance.  It records all the reasons why the public is now paying for the 'innovation' failures of the medical device industry.  Rep. Erik Paulsen ignores patient harm caused by medical products and thereby puts patients and medical device industry jobs in conflict.  Follow the money:  it is definitely corrupting our healthcare system. Secure Minnesota jobs are dependent upon creating value, not aggressively pursuing profit at all costs to ethics and morality.  Patient safety must be the first consideration and our government leaders pledge to put citizens rights before business interests.

021013 

A Life Adversely Affected: You Kill Me, Boston Scientific!

This video is of a Texas woman who is disabled as a result of a Boston Scientific TVT sling implanted product.  

Keep this video in mind as you read the following:  medical device profit is private, patient harm as a result of failed innovation is often public - taxpayer obligation.  The patient is harmed and in medical and legal purgatory.  Public funds often are necessary to sustain families and the elderly from poverty and neglect.

 by SHIV GAGLANI on Feb 5, 2013 • 3:38 pm  FiDA highlight

Reporting from FutureMed 2/4/2013-2/9/2013

The next speaker was John Abele, the founder of Boston Scientific and chairman of FIRST (“For Inspiration and Recognition in Science and Technology”), which promotes student involvement in robotics. Abele mirrored Diamandis’ talk and gave an overview of certain elements to consider when thinking about exponential growth and the “law of accelerating returns.” He began by opening up with the prediction that “advances in technology in the next five years will exceed those in the past five years.” There are a number of reasons for this including the improved access to and democratization of information, ability to communicate with experts, more and better materials for modeling and analysis, cheaper and more powerful tools for testing, increased ability to learn new skills, and the long-tail phenomenon that speaks to the rise of niche markets. One of the specific issues within medicine however is that while med tech is also growing exponentially, the rate of medical technology assessment is still growing linearly, leading to a bottleneck of the implementation of potentially life-saving technologies. Abele spoke of an “omission versus commission” problem: regulators often do not approve innovations that may save 10 lives for fear that they will adversely affect one life. Aren’t we effectively killing 10 people by not approving some of these technologies? That question leads to deep philosophical arguments (Kant v Mill, anyone?) that were beyond the scope of the 1-hour talk. Abele wrapped up by discussing the importance of collaboration to applying the law of accelerating returns to medical innovation.

(Mr. Abele,  FiDA fears that it is all about "returns" and profit and not at all about improving the lives of patients.)

A late-breaking story:  (partial copy only)

RELATED CONTENT

  

• View Photo
  Lynn Waits, 55, of Covington, Ga., …
• View Photo
  Susan Harrison, 63, of Lawrenceville, …

ATLANTA (AP) — Soon after her surgery, Susan Harrison had a string of infections that caused intense pain, leaving her weak and unable to pick up and play actively with her young grandchildren. The discomfort and fatigue often kept her from her job as a kindergarten classroom assistant.

For years, Harrison thought it was just an unfortunate consequence of the surgery to repair weak muscles in her pelvic region. But she discovered five years after her 2006 procedure that she was one of thousands of women who say their pain was caused by surgical mesh implanted to fix the problem.

"I felt so bad, I felt sad thinking that I had to spend the rest of my life living this way," Harrison said.

The mesh is most commonly used after pelvic organ prolapse, or when muscles in the area weaken, causing organs to bulge or slip down into the vagina. It can happen because of age, childbirth or other reasons and can cause pain and bladder leakage.

While many women benefit greatly from the mesh surgery, the Food and Drug Administration has warned some can suffer complications, and many women have sued, claiming manufacturers should have warned of potential harm. But some doctors have said the FDA's warning — and the lawsuits against the manufacturers — are misguided. The doctors blame inexperienced surgeons.

Harrison's case is among more than 6,000 federal lawsuits against some of the biggest manufacturers of pelvic mesh products. The cases have been consolidated in a federal court in West Virginia, with some trials to begin this year.

The lawsuits accuse the companies of inadequate testing, failing to disclose potential risks and fraudulently promoting the mesh as a safe medical device. The manufacturers deny those allegations in court documents. Some companies have said in statements their testing was rigorous, that their products are safe and effective and that they're working with the FDA. Some companies declined to comment, citing ongoing litigation.

The lawsuits seek unspecified compensation for pain and suffering, reimbursement of medical costs and punitive damages.

Harrison had most of the mesh removed in October 2011. She said she still feels weak and has bladder leakage that requires her to take extra precautions when she leaves the house, but she feels better than she has in years.

Lynn Waits, a former police officer-turned-nurse from Covington, Ga., had incontinence and pelvic collapse after having two children. She said she experienced bleeding and severe pain immediately following her mesh surgery in 2008.

The incision next to her vagina never fully healed and she could feel the mesh if she touched that spot, she said. She continued to have bleeding for two years until she finally went to another doctor and had the mesh removed in 2010, she said.

She still has shooting pains, a constant achiness and can't take a long car ride without discomfort, which she blames on the mesh. The experience has also changed her marriage.

"Since I had surgery, sex is out. I'm celibate," she said. "Now it's a very platonic relationship. You get used to it."

Kathy Barton's doctor suggested the mesh when she mentioned that she had bladder leakage when she laughed or coughed. Shortly after the surgery, it felt like razors were slicing her organs and a sharp edge of the mesh cut her boyfriend during sex, she said. Even though she eventually had it removed, the 55-year-old west Georgia woman still has pain she believes is caused by the mesh.

When pelvic mesh products were introduced, they were seen as a high-tech improvement over traditional surgery using stitches and a woman's own body tissue, which also can have complications. Since similar mesh was already used in other types of surgery, including for repairing hernias as far back as the 1950s, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices.

The FDA cleared the mesh — often a soft, lightweight porous plastic — for pelvic organ prolapse in 2002, and the agency said in a 2008 public notice that problems were "rare." In July 2011, however, the agency said it erred in its initial assessment and estimated the most common problems occur in 10 percent of women within a year of surgery.

One of the lead attorneys representing women suing the mesh manufacturers, Athens, Ga.-based lawyer Henry Garrard, said problems may arise because some surgeons don't know much about mesh, but he said it's the manufacturers' responsibility to educate doctors about their products. For the most part, his clients have not sued individual doctors, he said, because he claims the problems are caused by the mesh products themselves.

A trial for five bellwether federal cases against Bard is set for June and trials for American Medical Systems, Boston Scientific and Johnson & Johnson subsidiary Ethicon are staggered over the next year.

Biomet Failed Metal Hips: Hundreds of Lawsuits

http://bit.ly/X4AqsA

Biomet Metal-on-Metal Hip ImplantLitigation Status Update

Posted on February 6, 2013 by Cal Warriner  

An MDL (multidistrict litigation) was established for the prosecution of individual personal injury lawsuits against Biomet in the fall of 2012. The Judicial Panel on Multidistrict Litigation (JPML) heard attorney arguments on September 20, 2012, at a hearing in New York City. The plaintiffs requested consolidation of the pending lawsuits involving Biomet’s M2a Magnum metal-on-metal hip implants in federal court in New York, Texas, or California, where lawsuits had already been filed by individual plaintiffs. Biomet resisted the establishment of an MDL, but suggested that it be based in New York or New Jersey if the JPML felt that MDL coordination of the individual lawsuits was necessary. The Judicial Panel rejected all of the suggested forums and established MDL No. 2391 before Judge Robert L. Miller, Jr., United States District Court Judge in the Northern District of Indiana. Judge Miller has been a member of the Judicial Panel on Multi-District Litigation since 2003. He was appointed as a federal judge in 1985, and has served as Chief Judge in the Northern District of Indiana since 2003.

As of January 14, 2013, there were 132 individual lawsuits pending in the MDL. Given the large number of adverse event reports filed by patients who suffered harm as a result of being implanted with the defective Biomet M2a Magnum metal-on-metal hip implants, it is anticipated that hundreds of additional lawsuits will be filed by injured plaintiffs in the coming months.

Judge Miller held his most recent monthly status conference on February 4, 2013, in South Bend. The judge is currently considering a number of issues in the litigation, including guidelines on the preservation of explanted hip implants and the forms to be utilized for discovery responses. The Court granted the plaintiffs’ request for another week to prepare a Fact Sheet form that was more comprehensive than the one submitted (but less onerous than the form proposed by the Defendants), in light of the judge’s comments that he would prefer to have a more comprehensive form. The parties are also working on reaching agreements with regard to electronic discovery and predictive coding, the first steps that need to be completed in order for the large-scale production of Biomet’s documents to begin.

At the recent status conference, the court also discussed scheduling issues, including a “science day” to educate the Court on the scientific issues pertinent to the Biomet metal-on-metal hip implant litigation. Those presentations are expected to occur in May of 2013. If discovery proceeds as intended, it is likely that the Court would be in a position to begin the selection of individual cases for case-specific discovery and bellwether trial preparation as early as January of 2014. We anticipate that a number of orders will be entered this month to help streamline the litigation process. The next status conference in the Biomet MDL is scheduled for March 18, 2013.

Howard Sadwin: Video of Medical and Legal Purgatory

Howard Sadwin, too late, sees clearly the trap that he entered when he got his second failed hip.  He has researched the ecosystem of toxic lies & misinformation that are told by medical device sales reps, hospital administrators, FDA regulators and even elected officials.  He traveled to Washington DC June 27 and 28, 2012 to testify and share this information with the public.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm306172.htm

See Howard's Testimony at 1:52:52

 According to Howard, no journalist has yet to go beyond hip trial or personal stories.  It is time to tell the full story to protect our nations' healthcare funding.  Allowing failed devices to compete directly with functioning devices exposes patients to devastating harm.

Pre-emption laws are not events mentioned nor understood.  The media can help expose this flaw.

The FDA was created for our safety and well being yet the pre-emption laws protect PMA approved devices.  The pre-emption laws were to prevent patients from suing manufacturers for every little issue.  They were not created to harbour a manufacturer from prosecution when their device malfunctions, hurting thousands.   (Such as Smith&Nephew’s Birmingham Hip Resurfacing device (Bhr). ) The 5^th amendment gives us the right to Due Process, part of the Bill of Rights protets against abuse of government authority in legal procedure.