ALL OF MARYLAND CANDIDATE'S FOR GOVERNOR WILL CONTINUE THIS GLOBAL CORPORATE STRUCTURE FOR HEALTH CARE EXCEPT CINDY WALSH FOR GOVERNOR
I listened to a NPR------corporate media all the time----report on the escalating problem of medical procedures and devices passing FDA approval and failing and sometimes killing the American people. The numbers are soaring as the FDA is now working to send these products to market for profit and allowing the failures to be discovered after the fact by harming the citizens of America. This NPR article looked at one medical procedure that was approved by the FDA after a supposed 'clinical trial' of a few hundreds of people. The entire process looked to be filled with false data and sketchy connections with who and how the medical research was conducted and if any of the results were reproducible or if the efficacy was real.
ERGO-----THE ENTIRE PUBLIC HEALTH CLINICAL TRIAL PROCEDURE IS BEING DISMANTLED AND THE GENERAL PUBLIC WILL NOW BE THE TEST SUBJECTS. IF HARM IS DONE-----TOUGH LUCK AND WE WILL ALLOW THE BAD MEDICAL PROCEDURE TO CONTINUE REGARDLESS IN ANOTHER FORM.
This is what a corporate state looks like and it is Trans Pacific Trade Pact already in action as Obama has filled his Federal agencies with the same kinds of people that Bush did-----people committed to global corporate control of all public policy.
THIS IS WHAT YOUR ELECTIONS FOR GOVERNOR AND MAYOR ARE ABOUT-----WE THE PEOPLE MUST WIN THESE ELECTIONS!
What is happening as well is that Obama and your neo-liberal Congress person sent hundreds of billions of dollars to higher education under the guise of building stronger education but what they are building are corporate university research facilities complete with patenting of research done at this university. Most institutions receiving those hundreds of billions to build their corporate R and D? Ivy League universities like Johns Hopkins. What this policy does is make these universities corporations that receive tons of public taxpayer money to subsidize research in the guise of education while it is simply a patent machine for corporate R and D. When you see BIOPARK outside of Johns Hopkins or University of Maryland Medical System in Baltimore (a quasi-institution, not public so they say) ---you are seeing the public subsidizing with what is called education funding the profits of what are now corporations.
More important is combining this with the fact that the clinical trial structure and fast FDA approval of these patented procedures, devices, or medications that are simply rubber-stamped and you have ABSOLUTELY NO PUBLIC OVERSIGHT OF ANY OF THE HEALTH INDUSTRY ACTIONS. Remember, universities----especially public universities ------were the one institutions charged with making sure the data and research of products protected the people. These corporate structures built by neo-liberals like O'Malley and neo-cons like Erhlich are now doing just that.......creating an unaccountable and fraudulent system in our medical research structure.
OBAMA AND NEO-LIBERALS IN CONGRESS-----ALL MARYLAND POLS ARE NEO-LIBERALS------DELIBERATELY SENT MONEY TO BUILD WHAT THEY KNOW WILL HURT AND/OR KILL CITIZENS IN THE NAME OF CORPORATE PROFIT.
This is what Trans Pacific Trade Pact and the Affordable Care Act is all about.....consolidating the health industry into global corporate health systems that are deregulated and unaccountable and that will do harm without a second thought in pursuit of profit. This is what the Maryland Health reform has done these several years under O'Malley and Rawlings-Blake in Baltimore-----created the structures to allow all this to happen and with no oversight or accountability structures.
SEE WHY CINDY WALSH FOR GOVERNOR OF MARYLAND AND HER PLATFORM MUST BE KEPT OUT OF THIS ELECTION????
'The 510(k) loophole
Although the FDA requests clinical data in about 10% of cases, one concern over the 510(k) system is that testing is insufficient and so products that are either unsafe or ineffective could be released to market'.
Please read below to the 510 loophole.....it has made the FDA just as the SEC----working for corporate interests against the people's interests. That is what a corporate state does.
How does the FDA 'approve' medical products?
Thursday 20 February 2014 - 8am PST
Written by David McNamee Medical News Today
You may have seen medical products that claim to be "FDA cleared," "FDA registered," "FDA listed" or "FDA approved" - but what do these labels mean? You would be forgiven for feeling confused.
In this feature, we look at what the differences in Food and Drug Administration (FDA) classification actually mean, what you need to be aware of as a consumer and what the future holds for the regulation and classification of medical products in the US.
Though you may see labels on a wide variety of medical products - from implantable defibrillators to smartphone apps - bearing legends such as "FDA registered," in reality these claims are often disingenuous. But regulation over the correct terminology is rarely enforced.
Class 1, 2 and 3 In truth, the only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology (such as defibrillators). These are submitted to a rigorous review process called "pre-market approval" (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient.
The only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology. Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Just 1% of products pass PMA.
Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.
Vitamins, herbs and supplements are not tested by the FDA unless they are an active ingredient in a drug that requires FDA approval - so manufacturers of supplements are not allowed to claim that their products can treat any specific disease, only that they "promote health."
Despite this, some supplement companies are known to illegally claim their supplements are "FDA approved." It is thought that the FDA are unable to intervene in every instance due to limited resources.
Low-risk medical devices, such as stethoscopes and gauze, are known as "Class 1" and are exempt from FDA review.
"Class 2" medical devices are defined as not life-sustaining or life-threatening, though this category covers a wide spectrum of devices, from X-ray machines to some exercise equipment.
The level of scrutiny attached to Class 2 devices is much lower than Class 3. The devices do need FDA "clearance" before they can be marketed and sold, but rather than submit their products for clinical trial, the manufacturers are required instead to convince the FDA that their products are "substantially equivalent" to products that have been previously cleared by the FDA.
Substantially equivalent means that the device has the same intended use and approximate technical characteristics as an existing product.
Products that pass this clearance process may be referred to as "FDA cleared" or "FDA listed," but this is not the same as "FDA approved," which only relates to the prescription drugs and Class 3 devices that have passed PMA.
This approval method for Class 2 devices has been the subject of mounting controversy. The process is known as "510(k)" - named after its section in the law.
The 510(k) loophole
Although the FDA requests clinical data in about 10% of cases, one concern over the 510(k) system is that testing is insufficient and so products that are either unsafe or ineffective could be released to market.
Under 510(k), devices that have passed clearance, but have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA's list of cleared products. Another worry about this process is that the more "substantially equivalent" (but not identical) products are listed, the more a chain grows of FDA-cleared products that increasingly move away from the original product.
But perhaps the most concerning feature of 510(k) is that devices that have passed clearance, but then have later been found dangerous or ineffective and are recalled, are not automatically removed from the FDA's list of cleared products.
This is a loophole that allows any new products bearing the same faults to remain eligible for FDA clearance through 510(k).
In a 2012 report, the Institute of Medicine (IOM) recommended that 510(k) be replaced with an "integrated pre-market and post-market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle."
But these recommendations - though popular with consumer advocacy groups - were rejected by the FDA.
A congressman (now senator) for Massachusetts, Ed Markey, campaigned for the reform of 510(k) and proposed a 2012 bill to close the loophole.
But the bill was not passed. It received opposition from medical device manufacturers and members of Congress who claimed that the existing FDA review processes are already too time-consuming and unpredictable, compared with other countries, so inserting more safeguards and regulatory steps would have the effect of strangling innovation.
Medical News Today spoke to Dr. Michael A. Carome, director of the non-profit consumer rights organization Public Citizen's Health Research Group, about 510(k).
Dr. Carome cites a report that Public Citizen issued in 2012 highlighting "a concerted lobbying campaign intended to weaken the already lax regulatory oversight of medical devices."
"For example, in 2011 the medical device industry spent $33.3 million on lobbying, raising its total to $158.7 million since 2007. This lobbying campaign has been very successful and has generally drowned out calls for stronger medical device regulation from consumer advocates like Public Citizen."
Carome also sees a second obstacle in the FDA itself, "which has been very resistant to proposals to strengthen or replace the 510(k) system."
"The FDA seems beholden to the medical device industry and the mantra that promotion of 'innovation' is the most important goal in the regulation of medical devices," he adds.
More recently, Sen. Markey wrote to the FDA, appealing directly for them to reform 510(k).
Sen. Markey was satisfied with the FDA's response, announcing in December 2013 that database modifications proposed by the agency "will help decrease the dangers and increase the awareness of medical devices that may be made based on flawed models."
Dr. Carome feels, though, that the FDA's proposed measures "fail to adequately address the underlying flaws in the 510(k) premarket clearance process."
The central issue remains that new Class 2 medical devices found to be "substantially equivalent" to recalled but previously cleared devices are still obliged - by law - to be cleared by the FDA, despite whatever flaws the devices contain.
"The slightly improved transparency provided by FDA's revised database for 510(k)-cleared devices does not close this dangerous loophole in the existing law that threatens patient safety," Carome concludes.
But what are the Class 2 devices that have caused patient safety concerns?
Carome points to the DePuy metal-on-metal Articular Surface Replacement (ASR) hip implant - an "example of a medical device heavily promoted as being innovative and better than earlier types of devices."
In November 2013, DePuy - an orthopedics company owned by Johnson & Johnson - announced a $2.5 billion settlement to resolve more than 8,000 of 12,000 public liability claims filed in US courts after their metal-on-metal hip was recalled in 2010. The ASR was found to shed metallic debris as it wears, causing pain and injury to the patient.
The Myxo ring In 2008, a surgeon named Dr. Patrick McCarthy at Chicago's prestigious academic medical center, Northwestern Memorial Hospital, was found to be installing a device he had invented - the McCarthy Annuloplasty Ring - into the hearts of cardiology patients without the informed consent of the patients.
"If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered," says Dr. Rajamannan. Concerned patients were even more alarmed when they discovered that the ring had also not been submitted to the FDA for review.
"There are no guideposts for us. You don't learn about this stuff in med school," McCarthy was quoted by the Chicago Tribune as saying, when questioned on why he had bypassed FDA approval.
The ring's manufacturer, a company called Edwards Lifesciences, later falsely claimed that the device was exempt from the 510(k) process and so did not require FDA clearance.
When a concerned colleague of McCarthy's, Dr. Nalini Rajamannan, contacted the FDA, an investigation was triggered, which ultimately saw the ring cleared for use - despite having already been sewn into the hearts of 667 patients.
But further controversy surrounded the FDA's clearance, which simply relied on a clinical study Dr. McCarthy himself had written as evidence that the ring - now rebranded "Myxo dETlogix" - was safe and effective.
Dr. Rajamannan - who was co-author on that study before withdrawing when she learned that the patients involved were not giving informed consent - later wrote a book detailing the controversy and continues to campaign on behalf of patients installed with the Myxo ring.
Speaking to Medical News Today, she says that the concerns over the Myxo device have still not been addressed by the FDA:
"The FDA has written a formal letter stating that they would not be investigating the matter any further. These heart valve rings that are being cleared under the 510k process for Edwards Lifesciences are associated with over 4,000 adverse events and over 645 deaths."
"The other major heart valve manufacturers have less than 20 events for their rings in the FDA database."
What does the future hold for FDA regulation? As we have shown in this feature, the confusion over the various stages of FDA "approval" and "clearance" is not limited to patients. These examples show that FDA classifications and processes can also - naively or wilfully - be misinterpreted by manufacturers and medical professionals.
The concerns from doctors, patients and consumer advocacy groups on the lack of regulation of medical products and the conflicts of interest within those regulatory processes remain.
Dr. Carome recommends that the IOM's 2012 guidelines be implemented and suggests that more of the Class 2 products sped through to market under 510(k) need to be reclassified as Class 3, for which the PMA process is much more stringent.
"Manufacturers do heavily promote their devices as being new and innovative, and many health care providers and patients believe that a 'newer' or 'innovative' device must be better," reasons Carome. "However, in most cases, there is no evidence that the newer medical devices are any better than older devices or other less-invasive treatments that don't involve a medical device."
"It is a real safety problem," agrees Dr. Rajamannan, who adds: "If you are planning to receive a medical device in a US hospital, there is no way to confirm whether the device is FDA approved, investigational or registered."
"The patients in the US are at major risk and the FDA is doing nothing to help the patients."
As I said, Maryland TV is plastered with injury law firms gathering patients that are victims of this horrendous system. As we all know, the injury lawyers get all the money in the end and the patients are harmed for life. This is what a third world nation looks like----citizens cannot even seek medical help without being fearful the procedures are happening in their interests and not for profit.
In Maryland, the Maryland Assembly has passed laws that make it as hard as possible for the public to seek justice in medical malpractice and it does not require medical malpractice insurance---meaning doctors prone to bad practices would love to come to Maryland. NONE OF THESE POLICIES ARE DEMOCRATIC----YET MARYLAND IS CALLED A 'PROGRESSIVE' STATE. It is a neo-liberal/neo-con state.
New Jersey Personal Injury Blog FDA Failed to Properly Test Medical Devices before Approval
By Blume Donnelly Fried Forte Zerres & Molinari
on March 9, 2011
CNN recently reported that a review of recall data from the U.S. Food and Drug Administration (FDA) found that the majority of the 113 Class III medical devices that were recalled between 2005 and 2009 for serious, life-threatening dangers, did not undergo the FDA’s more rigorous pre-market approval process, also referred to as “PMA.” Instead, the agency cleared the devices using a less stringent process known as the 510(k) process, under which clinical testing is not required. This discovery brings to light that many medical products that were given clearance, such as automated external defibrillators (AEDs), artificial hip joints, and heart valves, were marketed to and used on consumers without undergoing clinical testing in advance.
Under FDA policy, all Class III devices are required to undergo the PMA premarket approval process, including clinical testing, in order to determine if “sufficient valid scientific evidence” is found that the medical device is safe for its intended use.
However, a report from the Government Accountability Office in 2009 discovered that approximately 66 percent of all Class III devices were approved using the less demanding 510(k) process instead of the PMA because it was “less burdensome”. An additional study, published in the Journal of the American Medical Association’s Archives of Internal Medicine, found that approximately 71 percent of the 113 medical devices recalled between 2005 and 2009 were given approval through the 510(k) process.
Many believe the reasons for the shortcomings in testing are because the agency does not have the necessary funding and staff to conduct a clinical study for all medical devices requiring same. While a medical device’s manufacturer does pay for a fraction of the expenses related to a PMA approval, the majority of the cost falls to the FDA, which is under-funded. Choosing to approve a medical device under the 510(k) process is much less expensive.
The FDA has admitted that the 510(k) approval process needs to be toughened, and has stated it intends to take action to improve the process in 2011. Additionally, the FDA has stated it will evaluate all remaining Class III devices slated for the 510(k) process to determine if the device should undergo the PMA process. As a result, there may be dangerous medical devices on the market that have not received proper government approval.
If you believe that a defectively designed or manufactured medical device may have seriously affected your health or the health of a loved one, contact a New Jersey product liability attorney at Blume Goldfaden. Call 973-635-5400 to schedule a no-cost consultation with one of our lawyers.
Keep in mind that a republican Bush slashed funding for most Federal agencies as a way to make oversight and accountability go away. So, when Obama makes an increase of 2-3% he is doing nothing towards rebuilding these agencies. In fact, much of the funding that makes it to these agencies is simply lost in private outsourcing with all its fraud and corruption.
When they say 'it's the sequestration and the national debt'
WE SAY----NO, IT'S THE FAILURE TO RECOVER TENS OF TRILLIONS OF DOLLARS IN MASSIVE CORPORATE FRAUD THIS LAST DECADE.
This funding status quo simply keeps our Federal agencies in a mode of 'doing no harm' to corporate profits.
STOP ELECTING NEO-LIBERALS! DO YOU HEAR YOUR POLS SHOUTING TO BRING BACK TENS OF TRILLIONS OF DOLLARS IN CORPORATE FRAUD! MARYLAND POLS LOVE FRAUD AND CORRUPTION SO THERE IS NOT A WORD
Once again republican think tanks are crying foul but they are the ones behind all of the dismantling of these agencies creating the fraud and corruption and loss of trillions of dollars. Their figures are right---$900 billion from Medicare will be taken from the patient's care and not hospital profits.
Reaction to Obama's 2015 HHS funding:
Various health care providers and organizations have responded to the proposal, with many calling for increased funding for health-related agencies and initiatives.
The Federation of American Hospitals criticized proposed funding cuts to Medicare, with FAH President and CEO Chip Kahn saying they would "further threate[n] seniors' access to vital hospital services" and noting that both Republicans and Democrats oppose such reductions (Demko/Zigmond, Modern Healthcare, 3/4). According to National Journal, the group is hoping to persuade Congress against the cuts by touting a new study estimating over $900 billion in Medicare savings over the next 10 years through cost cutting resulting from changes to the way providers deliver care (Ritger, National Journal, 3/4).
American Hospital Association President and CEO Richard Umbdenstock said the proposal contained some "problematic policies" that would hurt hospitals' abilities to improve the health care system and place patients' at risk of losing access to services (Demko/Zigmond, Modern Healthcare, 3/4).
Kasey Thompson, president and chair of the Alliance for a Stronger FDA and vice president of policy, planning and communications for the American Society of Health-System Pharmacists, called for additional FDA funding, saying, "Given that FDA regulates about 25 cents of every dollar of the gross domestic product, it does not have enough money to fulfill its public health mission."
Alliance for a Stronger FDA Deputy Executive Director Steven Grossman added that the group plans to ask Congress for more FDA funding (Lee, Modern Healthcare, 3/4).
The proposed increase in NIH funding also generated backlash. Research! America President Mary Woolley in a statement said that the U.S. "simply cannot sustain [its] research ecosystem, combat costly and deadly diseases ... and create quality jobs with anemic funding levels that threaten the health and prosperity of Americans," adding, "These funding levels jeopardize our global leadership in science -- in effect ceding leadership to other nations as they continue to invest in strong research and development infrastructures" (Viebeck, "Healthwatch," The Hill, 3/4).
This is how crazy things have gotten. California is indeed ground zero for this university as corporation model starting with Stanford and now consuming all public universities. Remember, California had the best education system in the world----I had the pleasure of attending California schools at all levels-----but this move to corporatize has ruined the entire higher education system and they are now creating the tiered higher ed as they are in Maryland with working and middle class being tracked into vocational K-career college.
This is critical to health care because these large universities whether public or private are the source of public protections for health. If the data is corrupt at universities-----no one is watching the health corporations either. So, if you think funding universities by making them corporations is a good idea----THINK OF ALL THE FACTORS CONNECTED TO THIS.
It is interesting to note that Governor Brown-----who will try to run for President as a 'progressive' on his old record as a real progressive in the 1970s---appointed Napolitano-----HEAD OF HOMELAND SECURITY WITH NO EDUCATION BACKGROUND as Chancellor of California Higher Education School System.
THE CONTINUED USE OF INSIDERS FILLING APPOINTED POSITIONS AT ALL LEVELS.
When they talk of 'start ups from this university research' they do not tell you that 9 times out of ten those start-ups that are successful are simply absorbed into global corporations. IT IS A PIPELINE. Keep in mind that these corporate universities sell this corporate structure as funding schools but it is this structure that has student tuition sky high subsidizing this research and patenting process. Maryland has done the same to its universities as this article shows in California and it is where all public funding for education is now going. Johns Hopkins has had so much money funneled to it from our Congress neo-liberals that it owns much of the land in Baltimore's downtown and city center and it is all simply businesses connected to Hopkins. THIS IS HOW YOU BUILD A GLOBAL CORPORATION THAT CONTROLS A REGION----
Patent-reform legislation spurs controversy among universities
Tina Pai/Staff By Tahmina Achekzai
Last Updated April 28, 2014
In 1994, Michael Doyle, then the director of a computer lab at UCSF, patented software that allowed doctors to view embryos online — the first “interactive” application on the web.
A few years later, the University of California licensed a patent to a company Doyle created called Eolas, which, claiming rights to the idea of embedding interactive content on web pages, sued Microsoft in a multimillion-dollar lawsuit.
The university, a co-plaintiff in the case, took a $30.4-million cut in what is now widely regarded as a classic case of “patent trolling.”
This week, Congress is marking up legislation in hopes of combating patent trolls — companies that purchase patents not to commercialize a product but to reap licensing revenue.
The UC system holds nearly 4,000 U.S. patents that have led to thousands of inventions and hundreds of startup companies. The University of California leads the nation’s universities in patent development, but pending legislation may change that.
Politicians vs. trolls
Traditionally, researchers apply for patents that give them full ownership of their idea or invention and then sell the rights to outside companies, hoping to take their discoveries from the lab to industry. But when the inventions seem to have little hope for commercialization, “patent trolls” may step into the picture.
Trolls, more formally known as patent-assertion entities, will find and subsequently sue businesses they accuse of infringing patent rights. Serving as a middleman between inventors and businesses, trolls collect licensing fees, a portion of which the inventors may receive.
According to the 2013 White House Patent Assertion and U.S. Innovation Report, suits filed by patent trolls tripled from 2010 to 2012, at which point they comprised 62 percent of all patent-infringement cases.
Experts say that because it costs millions of dollars to ascertain what a patent covers, companies faced with these lawsuits may choose to settle rather than to fight.
In November, Sen. Patrick Leahy, D-Vt., introduced a bill hoping to increase transparency within the patent system and to curb the emerging trend of patent trolling.
The bill would require any patentee who has filed a lawsuit to disclose any financial interests. It also requires the Federal Trade Commission to exercise authority over the misuse of demand letters: notices to companies claiming restitution for breach of license.
Though the legislation is designed to serve as a deterrent to patent trolls attempting to sue other parties, universities worry it will invariably impede their efforts to enforce their own patent rights.
Earlier this month, the Association of American Universities — of which the UC system is a part — signed a joint letter addressed to Leahy outlining its concerns. The letter was also signed by the Association of University Technology Managers, made up of representatives from “technology transfer” offices at many universities who guard university research.
“Much of the legislation that is currently under discussion in Washington goes far beyond what is necessary simply to prevent that abuse of the patent system,” said David Winwood, the vice president for advocacy at the Association of University Technology Managers.
Of particular concern among both universities and members of Congress is the possible addition of a fee-shifting provision, which would require the losing party in a lawsuit to cover fees and expenses incurred by the opposing party.
Carol Mimura, UC Berkeley’s assistant vice chancellor of intellectual property and research industry alliances, explained that the threat of incurring additional fees could discourage universities from filing lawsuits against actual infringers.
“The provision favors large, deep pockets, not the little guys,” Mimura said in an email. “Big companies and deep pockets create a David and Goliath situation that discourages investment, as opposed to encouraging it.”
While the university protects its employees, co-inventors are sometimes undergraduate students who are not protected and would have to pay for the damages. As a result, she said, they may be discouraged from filing patents — and, consequently, inhibited from advancing “innovation.”
Gary Falle, UC’s associate vice president for federal government relations, argues Congress needs to take a more “balanced approach” when addressing patent abuses.
“The UC is the lead in the nation in the number of patents (awarded annually), and we want to make sure that is protected,” said Falle. “We just want to make sure that the patents the university is awarded are able to move into technology, commercialization and innovation.”
Trimming the troll
Yet Robin Feldman, a law professor at UC Hastings College of the Law who researches patent trolling issues extensively, believes the legislation is vital to the abused patent system.
Feldman suggested universities might have underlying incentives in opposing the legislation. She noted that universities, while not filing patent lawsuits directly, may deliberately ally with nonpracticing entities to increase revenue.
“They do appear to be feeding the patent trolls at least to some extent,” she said. “There’s so much pressure on universities to find funding sources, and it is difficult for them to resist the temptation to sell to those who won’t make any products.”
Still, according to Mimura, UC Berkeley only licenses patents to commercial entities in accordance with university patent policy. And, despite what history may suggest, Mimura said the University of California does indeed support patent reform and has even reached out to Sen. Dianne Feinstein thanking her for support of patent reform.
In regard to current legislation efforts, the UC system only wants to shift the discussion in the right direction, Falle said.
“We believe that addressing bad behavior by stopping those who send multiple demand letters in the hope of extracting fees out of fear will be the focus of reform — not shutting down the entire patent system that is the goose that laid the golden egg,” Mimura said.