Obama is a fox: Califf is the wolf. FDA headed to obsolescence?

Will Commissioner Califf Lead the FDA to Obsolescence? The Answer is Likely Yes. 

by Marcie Jacobs                 December 2, 2015         FiDA highlight

The more I think of Obama and his ways, the more I think he is playing chess. He certainly was playing chess with the ACA by pitting large employers and employees (169 million strong) and insurance companies and policyholders against big medicine and now this with the FDA. He knows the FDA runs counter to his mission so what does he do? He appoints a wolf to guard the henhouse. Why? It doesn't make sense unless he is trying to wake us up to smell the coffee. Any other way he dealt with the corrupt FDA would land him in hot water with his contributors and it wouldn't solve the problem. Most doctors come from the same cesspool as Califf and are practicing allopathic medicine because they can't break free from it. It was too profitable for them pre-ACA and now they believe they are trapped.  In addition, anyone he appointed would eventually do the same as our good ole boy Deputy Commissioner Califf.

From a post by Johanna Ryan, The Ghost of Research Future

"Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory”. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue."

For the sake of argument assume that he does become "The Ghost of Research Future" Ghost is a good word to describe an agency that has already lost its reputation and is about to lose all credibility in the eyes of consumers.  Like medicine, research in this country is being transformed and technology and big data are leading the way. In the future, the management of illnesses will be based on our unique genetic makeup.  Clinical trials will no longer be necessary; they are population-based research; the future of research is individual-based and unique for all of us.  And consumers will demand studies and treatment based on their genome. And they will prevent, treat and maintain their disease based on their own unique biological makeup, not something dictated by corrupt agencies within the government that operate at the benefit of big medicine and big pharma and not for the benefit of patients/consumers. 

Consumers in the new healthcare paradigm will become increasingly hostile towards FDA approvals. If it has the seal of approval from the FDA it has the seal of disapproval from consumers. Consumers will use FDA corruption against them.  Extra, extra read all about it, FDA approves the next new blockbuster drug and no one buys it. Company's revenue drops by double digits.  

So what does Obama accomplish by appointing a wolf? He wakes up the American people on both sides of the aisle and he shows us that the FDA is an organization that can't be trusted. And that lesson is invaluable if you want to stay alive in the 21st century.  It puts the ball in our court. We the People are the ones that will chop down the greed, not the corrupt politicians or the pharma-run cronies at the FDA. It is a brilliant move, force the American people into the battle and soon they will dismiss anything that comes out of the FDA and in doing so they will protect themselves and their families.

In the 21st century, it's all about the individual and their genetics so population-based research (Califf's baby) is out and the FDA is one step closer to obsolescence.  The FDA can control providers, inventors, and corporations, but they cannot control the consumer.  That is why it is up to us to control the market and medical drugs and products as well as what we eat by taking our health care dollars elsewhere no matter who pays.  

Posted 2nd December 2015 by Marcie Jacobs

Here's $200k! (Only requirement: live with pain of a faulty hip the rest of your life.)

Biomet reaches $56 million settlement over faultyhip replacements

Mon Feb 3, 2014 11:30pm EST

(Reuters) - U.S. medical device maker Biomet Inc will pay at least $56 million to settle a multi-district lawsuit relating to defective metal hip replacements, a court filing showed, ending a protracted legal tussle.

The litigation involves Biomet's metal-on-metal hip replacement device known as M2a Magnum. Hundreds of plaintiffs claimed in various courts across the country that the hip device led to injuries.

The lawsuits were combined and jointly heard at the federal court of Indiana, the state where Biomet is headquartered. The multi-district litigation began in 2012.

As part of the settlement, Biomet will deposit $50 million into an escrow account and another $6 million into an attorney fee fund, the filing showed.

The agreement with the plaintiffs shall extend to all pending cases, and any future lawsuit filed in a federal court on or before April 15, 2014.

Plaintiffs who have received a Biomet M2a 38 or M2a Magnum hip replacement system as part of an initial hip replacement that was rectified more than 180 days after it was implanted shall receive a base award of $200,000.

Biomet, however, maintains that the injuries, losses and damages were not due to its hip implants.

"Plaintiffs and Biomet are mindful of the uncertainties engendered by litigation and are desirous of settling and compromising their differences by entering into this settlement agreement," Judge Robert Miller wrote in his order.

Biomet said in a statement late on Monday that it is pleased to reach a settlement and resolve the lawsuits.

The case is Biomet M2A Magnum Hip Implant Products Liability Litigation (MDL 2391), Case No. 12-02391, U.S. District Court, Northern District of Indiana.

(Reporting by Sakthi Prasad in Bangalore; Editing by Supriya Kurane)

http://www.reuters.com/article/2014/02/04/us-biomet-settlement-idUSBREA1305Y20140204

Held hostage by medical device cheerleader: Representative Erik Paulsen (R-MN)

Push to kill medical device tax isseen as way out of shutdown

Article by: KEVIN DIAZ , Star Tribune Updated: October 2, 2013 - 10:14 PM

FiDA highlight

WASHINGTON – A small group of rank-and-file House members trying to break through the impasse in the government shutdown revived talks on Wednesday aimed at repealing a health care tax that falls heavily on Minnesota’s medical device industry.

The effort is being led by Minnesota Republican Erik Paulsen, who has cast himself as the champion of an industry estimated to employ 35,000 in Minnesota. Paulsen said he discussed his proposal Wednesday with Republican House Speaker John Boehner hours before House and Senate leaders were scheduled to meet at the White House with President Obama.

“I said this can and should be part of the solution,” said Paulsen, one of about a dozen House Republicans who have signaled their willingness to drop GOP demands of defunding or delaying the Affordable Care Act, often called Obamacare, as a condition of keeping the government open.

Paulsen sponsored a measure to repeal the medical device tax as part of a GOP government funding proposal that got 17 Democratic votes over the weekend. The Democratic-led Senate stripped the language as part of a broader dispute over Republican efforts to derail the Affordable Care Act, which rolled out this week.

Minnesotans in Congress from both parties have been pressing to undo a $30 billion medical device tax levied under Obama’s health care overhaul. But the two sides have been unable to agree on a way to make up the lost revenue.

Now, with both sides looking for an end to the government shutdown, the repeal effort has been caught up squarely in the protracted politics of the standoff.

Democrats, including Minnesota Sens. Amy Klobuchar and Al Franken, have said they are unwilling to repeal the tax as part of any GOP funding measure that delays implementation of Obamacare as the price for keeping the government open.

“I continue to believe that the current continuing resolution is not the best place to work out a medical device tax repeal that the president would sign into law,” Franken said. “I think the surest way to quickly reopen the government is for the House to vote on the Senate-passed bill to fund the government at its current levels. But I will take a careful look at any proposal that emerges.”

Meanwhile, Republicans have used the issue to attack Minnesota Democrats who voted against the repeal of the medical device tax as part of a GOP funding measure that puts off the health care law.

Despite the discord, Paulsen said the repeal effort represents the best opportunity for compromise. “The number one provision in this entire debate that has brought the most bipartisan support is repealing the medical device tax,” he said. “So we’ve got an opportunity to make that the linchpin as part of a solution.”

Paulsen said he has been in talks with a group of Republican and Democratic House members, including Wisconsin Democrat Ron Kind, an opponent of the medical device tax. Kind, however, has been working on a way to offset any lost revenues that might result.

Optimism from the industry

Industry leaders expressed guarded optimism about the new push on the medical device tax, which already has collected more than $100 million.

“There is reason for optimism that there is a critical mass and bipartisan support for repealing the tax,” said J.C. Scott, chief lobbyist for the Advanced Medical Technology Association.

The House voted last year to repeal the 2.3 percent excise tax on medical device makers like Minnesota-based Medtronic, which has said the tax could cost it $175 million annually. But efforts to win passage in the Senate have been stymied by Democratic concerns about losing one of revenue streams to pay for Obama’s 2010 health care law intended to cover some 40 million uninsured Americans. The repeal measure also has faced a White House veto threat.

White House officials contend that medical device makers will benefit from the new business created by the expansion of coverage to Americans who are now uninsured.

Where state’s senators differ

While Franken and Klobuchar have vowed to get the repeal through the Senate, they differ on a key sticking point: how to make up for the revenue.

Last year’s House-passed bill would have offset the lost taxes by shrinking insurance subsidies for low- and middle-income workers under the health care law. Franken said the GOP plan would undermine the goal of affordable health care.

Klobuchar said Wednesday that she is committed to repealing the medical device tax. However, she said, “the president has made clear that he will not accept changes to the Affordable Care Act as a condition for opening the government.” That doesn’t prevent a repeal in future negotiations, she said, adding that “the best way to get there is for the House to take up the Senate bill to reopen the government so we can have those negotiations.

Paulsen said House members are working on new revenue measures. “It’s definitely something that’s being conducted by rank-and-file members looking for a way out and a solution with bipartisan support,” he said.

Even if enough Democrats come on board, Paulsen’s greatest challenge may be convincing other Republicans.

“I would call it a win,” Paulsen said. “It would be a major accomplishment that helps the economy.”

explanthis

Oct. 3, 13

1:12 PM

The medical device industry is poorly regulated. I have been a patient advocate on the federal level for nearly 5 years, testifying at FDA meetings about the high rate of failure of implanted hips, knees and surgical mesh. The industry has fought UDI (unique device identification), legal protections for harmed patients, transparency of doctor/device mfg. financial relationships and independent outcomes registries to adequately inform patients and their providers. Right now, in WV federal court there are nearly 50,000 harmed women fighting for their civil rights and compensation for 'morbid disfigurement' from multiple manufacturers of surgical mesh. The 2.3% tax is warranted and capitulation to this entitled industry by our elected representatives is undemocratic. Research on 'Failed Implanted Medical Devices'.

Exposing device/physician financial relationships!

For doctors and med firms, a new eraof disclosure

•                Article by: JIM SPENCER , Star Tribune Updated: July 28, 2013 - 11:53 AM

FiDA highlight added

New federal law will expose ties to medical device, drug companies.

WASHINGTON – The nation’s medical device makers and drug companies will begin collecting this week what is expected to become a massive stockpile of data on their financial relationships with doctors, researchers and teaching hospitals.

A new federal disclosure law mandates that an array of pharmaceutical and medical manufacturers report payments to physicians, hospitals and other health care businesses that are more than $100 a year. Payments can include travel expenses, entertainment, consulting fees and research support.

The new rules emerged after six years of legislative and regulatory battles to address growing concerns that health companies were gaining inappropriate influence over research, education and clinical decisions. The provisions were eventually folded into the Affordable Care Act in 2010.

“Patients should have the right to know if their physician is getting paid by a certain drug company or has a financial interest in something that they are prescribing,” said Sen. Amy Klobuchar, D-Minn., who co-sponsored the 2007 bill to require disclosures.

Executives within Minnesota’s multibillion-dollar medical technology sector, as well as other health-related companies, say they hope the data will dispel worries that their financial ties with doctors and researchers lead to unethical behavior or unsafe patient outcomes.

“We need to restore public confidence in why a company like [ours] would be interacting with doctors,” said Tom Schumacher, vice president of ethics and compliance at Medtronic Inc.

Those ties lead to innovation and better care, said Chris White, the general counsel for the Advanced Medical Technology Association (AdvaMed). “The public needs to understand the value of these relationships,” he said.

A recent case that highlighted worries over doctor payments involved Fridley-based Medtronic, one of the world’s largest device makers.

The U.S. Senate Finance Committee alleged in October that Medtronic heavily influenced the content of medical-journal reports about its spinal fusion product, Infuse. The committee questioned whether doctors who supervised the studies understated Infuse’s risk and overstated its benefits while receiving $210 million in royalties and consulting fees from Medtronic over a 15-year period.

Medtronic has denied that it improperly influenced peer-reviewed reports or sought to minimize potential harm.

Sen. Chuck Grassley, an Iowa Republican who was the principal sponsor of the original bill, said Americans need a way to assess whether there’s an unethical relationship between a doctor advocating a product and the company that makes it.

“[Infuse] is an example of what this is aimed at, but it isn’t just aimed at Medtronic,” said Grassley, adding that his staff has found many other instances.

Dr. Eugene Carragee, a Stanford University surgeon and editor of the Spine Journal, was among those who revealed the links between Medtronic and the Infuse scholarship. “If your main mission is taking care of patients, you have an obligation not to be so financially vested in the outcome of the ­equipment you’re using,” ­Carragee said.

The new law doesn’t outlaw payments or business deals between companies and doctors or teaching hospitals, but it makes those transactions easily accessible to all Americans.

Starting Thursday, drug and medical companies must track transactions with doctors, teaching hospitals and some other health-related businesses. The first round of data must be submitted to federal regulators by the end of the year and will be made public by next September.

The new law comes with fines of up to $1.15 million for companies that fail to disclose. It also requires senior managers to sign off on the data, making them personally accountable to the Centers for Medicare & Medicaid Services, the agency compiling the information.

The federal disclosure law is much broader than a Minnesota one that since 1993 has banned certain gifts and required drug companies to reveal certain payments to doctors. The federal rules require disclosure of various forms of compensation to doctors or their immediate family members, including consulting fees, speaking fees, gifts, charitable contributions, royalty or license fees, stock options or other investment incentives. This includes payments of more than $10 or payments under $10 that together top $100 in a year.

“Virtually every interaction with a covered recipient has to be kept and analyzed,” said AdvaMed’s White.

Medtronic has spent more than a year and an estimated $10 million preparing to track interactions with an estimated 60,000 physicians.

Medtronic had to integrate and make adjustments to computer systems to make sure they capture information consistently. In particular, it meant identifying doctors who might have done business with different departments or company locations.

Schumacher said some doctors have told the firm they are uncomfortable with the change, saying “it’s not worth the stigma of having their income posted on a website.”

A greater concern may be that doctors don’t realize those dealings with will now be tracked.

The American Medical Association has a website devoted to the change and the AMA president posted tips in a blog.

Schumacher believes that may not have been enough. “I’m not sure the physician community knows this is coming,” he said.

At Advanced Circulatory, a 25-person company in Roseville, CEO Mike Black had to create a system for gathering payments and other valuable transfers to doctors or their immediate families. That includes more than software: It means making sure salespeople get information they never had to gather before.

Black estimates that the adjustments will cost his firm $20,000 a year to implement.

He already has heard from doctors who don’t want to participate in his company’s symposiums because they are afraid the free lunch might land them in a government database. Black worries that the new law will cause doctors “to shy away from perfectly legitimate educational opportunities” about his products, which are used to increase blood circulation.

Black has his doubts that many Americans will make use of this new trove of information. “I don’t believe the average consumer is going to take the time to go look at a database for a particular device or a

particular company,” he said.

Grassley counters that even if individuals don’t, the media will. Concern about negative publicity will discourage doctors from giving biased information, the senator said.

Doctors may not like it, Carragee acknowledged, but the law should help ensure that “research done with industry financing will have to be vetted.”

That’s “how science is supposed to work,” Carragee added.

Jim Spencer • 202-383-6123

gemie1

Jul. 28, 13

12:27 PM

Excellent! The patient has a right to know the relationship between a doctor and the manufactures of drugs and medical devices. A patient or a consumer has the right to know that their doctor does not have a conflict of interest when prescribing medical care.

3

0

explanthis

Aug. 1, 13

1:05 PM

The legislation is commendable if data is accurately compiled and shared with patients. The resistance to transparency is understandable, given the easy access that pharma and medical device industry operatives had to doctors for so many years. The conflicted doctors that miss this cozy relationship are not the doctors I wish to support with my trust and tax dollars. Thank you, Jim Spencer and StarTribune for reporting on this important story.

President Obama: Faulty Medical Devices

This is a joyous day!

President Obama has been re-elected.  

In his 2012 State of the Union Address President Obama indicated that he was aware of faulty implanted medical devices and that targeted regulation is necessary to strengthen the U.S. free market.  

“We've all paid the price for lenders who sold mortgages to people who couldn't afford them, and buyers who knew they couldn't afford them. That’s why we need smart regulations to prevent irresponsible behavior. Rules to prevent financial fraud, or toxic dumping, or faulty medical devices don't destroy the free market. They make the free market work better,” Obama said.

Removal of  conflicted regulators from decision-making and rescinding industry entitlements  heightens assurance to patients that implanted devices are safe and effective.  Patients with access to accurate post-market data from CMS and hospitals make informed decisions and patient harm is reduced.  Businesses that produce valued implants will thrive.  

Let's get to work!

Harmed patients blocked by Supreme Court & Citizens United

Alliance for Justice: Overturn Citizens United.

Harmed patients cannot access justice.  The system is rigged.