Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, December 30, 2015

Harvard public health expert: Patient Safety Needs Federal Regulation

Like aviation, patient safety needs federal regulation

A new federal agency should be established to oversee patient safety at healthcare facilities to reduce medical errors, Lucian Leape, adjunct professor of health policy at Harvard T.H. Chan School of Public Health, said December 10, 2015 at a National Academy of Medicine symposium on advances and challenges in patient safety and healthcare quality.

“We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)” that exists for airplane safety, Leape said in his remarks, according to a December 11, 2015 MedPage Today article. “That’s what we need and we should have said that [in the report], and I’ll say it right now,” said Leape, a member of the committee that created the report. “The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board.”
Now, he said, “The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do. We’ve spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline.”
Expert: More Oversight Needed for Health Facility Safety
Lucian Leape, MD, calls for an 'FAA-like' federal agency
by Joyce Frieden  News Editor, MedPage Today 
WASHINGTON -- The federal government should create a new agency to oversee basic practices at healthcare facilities and cut down on the rate of medical errors, according to Lucian Leape, MD, adjunct professor of health policy emeritus at Harvard School of Public Health, in Boston.
"We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)" exists for airplane safety, Leape said Thursday at an event here commemorating the 1999 release of the National Academy of Medicine's landmark report on medical errors, "To Err is Human."

"That's what we need and we should have said that [in the report], and I'll say it right now," said Leape, who served on the committee that developed the report.
"The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board," he told MedPage Today.
Leape acknowledged that human beings are more complicated than airplanes, but he added that right now, "The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do." Examples of the types of standards the agency would enforce include 100% handwashing, flu vaccines for all employees, and no central line infections, Leape said, adding that this would not involve questioning a physician's judgment regarding a specific patient.
Although "carrots," or positive incentives, would be the preferred way to get health facilities to do the right thing, Leape acknowledged that "sticks" might be needed too. "We've spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline," he said.
Other speakers at the event, which also celebrated the 2001 release of "Crossing the Quality Chasm: A New Health System for the 21st Century," included Dan Ariely, PhD, a professor of psychology and behavioral economics at Duke University in Durham, N.C. Ariely discussed ways to help patients comply more easily with their treatment regimens.

The basic idea, Ariely explained, is that people are more interested in the short term than in the long term, so providers can use that knowledge to motivate people in the short term to do something that will be good for them in the long term. For example, Ariely said, when he was diagnosed with hepatitis C and had to give himself a shot of interferon three times a week as part of a clinical trial, he dreaded doing it because the side effects were extremely unpleasant.
However, he knew that taking the interferon could cure the disease and prevent the need for a liver transplant down the road, so he rewarded himself immediately after each shot with watching a video that he was really looking forward to. "A year and a half later, I was free of hepatitis C. My physician told me I was the only patient in the protocol that took the medication on time," he said.
Another strategy to help with compliance involves "loss aversion" -- the idea that people hate to lose money or something else they value more than they enjoy gaining something, Ariely continued.
In one experiment, "We gave people $3 a day to take their medication on time. What happened? Absolutely nothing," he said. "What if we took away $3 every time they didn't take their medications on time? The [institutional review board] wouldn't let us do that ... but what they allowed us to do is pre-pay people as if they took the medication for 3 months in advance ... and then take the money back, and that worked better."
During a question-and-answer session, Ariely was asked how motivational techniques could be used to help physicians and other providers comply with rules like handwashing. "I don't think it's about small punishments or rewards. These things we need to treat very differently ... they need to be either habitual or ritualistic," he said.

For instance, "Very few physicians don't wash their hands when they go to the OR. But the OR has a tremendous ritualistic element -- the surgeons stand there, people dress them -- there's a whole ceremony around it that's incredibly addictive."
As with the rituals surrounding religion, "It's not just about the action, but providing a higher-order meaning," he said. "A lot of things in medicine should look like that, but if you have 12-minute appointments and lots of paperwork to fill out, it's a little harder to feel a connection to a higher-order meaning."
Audience members also heard from experts in other industries whose structures might also apply to healthcare. For instance, Conrad Grant, head of the air and missile defense department at Johns Hopkins University Applied Physics, Laboratory, in Laurel, Md., compared hospital intensive care units (ICUs) to defensive weapons systems.
"In the ICU [unlike a weapons system], many systems have been designed for individual purposes, and have not been integrated into a coordinated set of systems," he said. "In certain situations, [these systems] may even be working at cross purposes if they are not correctly configured. There are so many straightforward improvements we could make today with an immediate reduction in preventable harm."
Grant gave one example in response to a question about "alarm fatigue" ICU nurses get from having device alarms -- many of them false -- constantly going off. "In weapons systems we also have alarms ... that go off with threats that present themselves or when the conditions of the ship aren't what we want them to be."

"We have carefully tried to engineer that so they're not so repetitive and constant that they become overwhelming," he said. "Part of the way to eliminate alarms is to cross-correlate systems that trigger the alarm ... if you couple it with second sensors that would recognize the same set of conditions and look to see if both of them are showing that same condition before you trigger the alarm, you have some verification."

Friday, December 18, 2015

MedShadow: Questions for Robert Califf, MD

Questions for FDA Commissioner Nominee

By Suzanne B. Robotti  @Med_Shadow  MedShadow Foundation
Published: November 24, 2015  FiDA highlight

Many people have questioned whether cardiologist Robert Califf, MD, has the ability to maintain (or rebuild, depending on one’s point of view) the wall between the FDA drug approval process and inappropriate intervention from pharmaceutical companies if he is selected to be the next Commissioner of the governmental agency. Dr. Califf has worked closely with most pharma companies and the very fact that those companies aren’t opposing his nomination encourages speculation that the FDA will slip even further into closer alignment with pharma’s goals.
Questions regarding Dr. Califf’s ties to the pharmaceutical industry are important and need to be fully explored. However, independence is only one worthwhile question for him. I have many more for Dr. Califf or any FDA Commissioner nominee:
What will you do about the 2.3 million people who are rushed to the ER each year due to side effects of drugs prescribed to them? Or those 117,752 deaths due to adverse drug events in 2013? That’s nearly 4x as many fatalities from guns, 33,380.
You state that you want to institute an adverse events reporting system for medical devices, similar to the existing one for drug reporting. Have you ever tried to look up a drug on that system? As a consumer, I have found it to be a nightmare of charts, repetitious and incomplete information. What will you do to improve the FAERS system?
Seniors take multiple prescription and OTC meds daily. About 35% take 5 or more prescription medicines. Older adults are 2x as likely as others to arrive at emergency departments for adverse drug events. Do you see a role for the FDA in reducing medication errors that cause adverse events or an agency effort to decrease the incidence of the over-medication of seniors?
What will you do about doctors giving drugs never tested on children to children?
The US and New Zealand are the only 2 countries that allow prescription drug advertising directly to consumers (DTC). What is your opinion about the benefits vs the risks of DTC drug advertising? Would you consider joining the AMA in calling for an end to this practice?
What is the FDA’s responsibility in ensuring that drugs approved for a specific, narrow group of patients do not become broadly prescribed? Example: opioids and the growing death toll from the overuse and addiction of these painkillers.
Off-label prescribing has been shown to have a significantly higher rate of adverse events, according to a Canadian study published this month in JAMA. Is there a way to control and lower the amount of off-label prescribing? Do you see a need for this?
What about post-approval studies? Why aren’t pharma companies penalized for not getting them done instead of being granted extension after extension? A “common” side effect is one that happens in 1 in 100 users. When a study includes only 100, 250 or 500 people, that side effect, even though common, may not be detected until the medicine has been approved and is in the marketplace. Post-approval studies are the best way to track and inform people about the growing list of known side effects for any drug.
Will you demand that all research, even those studies stopped or not published, be submitted for review during the approval process?

Do you have questions? Write the members of the Senate Committee that is making the recommendation regarding the FDA Commissioner nominee to the full Senate. The committee is named HELP. Write soon as the recommendation will head to the full Senate soon.
All the Senators on the HELP (Health, Education, Labor, & Pensions) Committee are listed in the chart below

If one of your Senators is on the committee, please send your Senator’s health care staffer a message. Also send emails to the leaders of the HELP Committee: Chairman Lamar Alexander’s (R-TN) staffer and Ranking Member Patty Murray’s (D-WA) staffer.
If neither of your senators are on the HELP Committee, please send emails ONLY to Senator Alexander’s and Senator Murray’s staffers. 

Staff members for the HELP Committee are listed at the end of the link above. NOTE: If the list indicates more than one staffer for your senator, send your letter to all of those staffers.
Thank you to the National Center for Health Research for guidance in writing Senators on the HELP Committee.
US Senate HELP Committee

Committee Assignment
Email Address
Barbara A.
Barbara A.
Susan M.
Susan M.
Susan M.
HELP, Chair
Michael F.
Robert P.
Michael B.
Orrin G.
HELP, Rank Member
HELP, Ranking Member

Tuesday, December 15, 2015

Medical Device Industry and FDA Collude

An Industry Takeover at FDA?

Posted in Regulatory and Compliance by MDDI Staff on December 15, 2015 FiDA highlight

A recent controversy highlights the close relationship between FDA and industry, with some critics calling discussion of key legislation by the regulator and the regulated unethical. 
Jim Dickinson is MD+DI's contributing editor.

If the Obama Administration and its improbable industry supporters have their way, Robert Califf will become, sometime in January, the first FDA commissioner to “capture” the agency from the inside with a full remit of enthusiastic support from its regulated industries.
Califf has been on the FDA payroll as a deputy commissioner since he came from a Duke University cardiology professorship last January—a move seen at the time as setting him up for the commissioner’s slot.
His nomination has been vigorously attacked for the same reason it was quietly aborted in 2009 in favor of Margaret Hamburg—his long career at Duke University consulting with numerous drug companies, far more contact, and much closer, than any prior commissioner.
Califf’s looming appointment would seem a far cry from the impartiality standard imposed on his predecessors, perhaps best expressed in the 1978 words of FDA’s then-chief counsel Nancy Buc—to demonstrate “a healthy tension” between the agency and the industries it regulates by maintaining an “arm’s length” relationship.
That sounds quaint now. It comes from ancient history, being in vogue long before user fees came to FDA in 1993, bringing in their wake radical changes to the previously nervous FDA-industry relationship.
Today fee-empowered companies and their multiple Washington lobbies routinely sit down with FDA and its congressional minders at distances closer than arm’s length.
Among other things, they write legislation together. Behind closed doors.
News about this erupted in December, scandalizing public-interest watchdogs like Pubic Citizen and the National Center for Health Research’s Diana Zuckerman, who told Inside Health Policy the practice would never have been tolerated when she worked on Capitol Hill (1985-95).
“As a senator, President Obama would have spoken out forcefully against this, but this is his administration, so what is he going to do about it?” she asked.
The online publication broke the story after receiving emails and documents from FDA pursuant to Freedom of Information Act requests that showed close collaboration between AdvaMed and FDA in developing the 21st Century Cures Act, which has passed the House despite criticism from former FDA commissioner David Kessler and others concerned that it could weaken FDA product approval standards.
For its part, Public Citizen publicly condemned senior FDA officials, including Califf, acting FDA commissioner Stephen Ostroff, and CDRH director Jeffrey Shuren, for “colluding” with AdvaMed on the bill, which the activist group said in a December 11 news release “would eviscerate the already far-too-weak safety rules for medical devices.”
Califf, it complained, “participated in at least one high-level strategy meeting with the industry regarding these efforts. No one from the FDA should ever have been involved in such a process, which violates the most elementary ethical standards...
“In response to this outrageous news, the U.S. Senate should, at minimum, halt consideration of Dr. Califf’s nomination until it has an opportunity to investigate fully exactly what occurred. We believe that news of Dr. Califf’s participation in this collusion with industry provides still further evidence that his nomination should be rejected.”
IHP reported that FDA and AdvaMed “had jointly written legislative text for Energy & Commerce chairman Fred Upton’s (MI) signature piece of legislation.”
The distinction between the unseemliness of FDA jointly writing legislative text with industry and conscientiously listening to industry’s viewpoints on the bill’s draft language seemed to be lost on both FDA and AdvaMed after the uproar arose.
An FDA spokesperson told IHP that agency officials “routinely meet with a diverse group of stakeholders” that include industry, as well as patient groups and consumer groups.
“With respect to 21st Century Cures, FDA met with industry, patient groups, consumer groups and other interested stakeholders to better understand their interests and concerns. Congress regularly asks us for technical assistance about how to modify language proposed by outside groups, as was the case here.”
An unnamed AdvaMed official was quoted by IHP as saying there’s nothing unusual about Congress seeking input from stakeholders, including regulatory agencies and trade associations during the legislative process. “The fact that an association and an agency might discuss how a particular piece of legislation might be operationalized or might impact them is not uncommon,” the official said.
Even a spokesman for the Energy & Commerce Committee weighed in to placate concerns that something untoward was going on with the 21st Century Cures Act. The committee and its members welcome input from all parties, including stakeholders, outside experts and government agencies, and encourages parties “in and out of government” to find consensus around specific policy proposals.
All just business as usual, no big deal, everyone said.
So who’s right? The public-interest complainers who were kept out of the joint FDA-industry legislation-writing meetings, or the insiders who participated and are happy with the process the way it is?
To my mind, the answer depends on whether you trust the government to do the right thing when it huddles with industry behind closed doors in one scenario while it tries to discharge its statutory, user fee-influenced responsibilities with the same industry in another scenario.
The IHP report said that when asked about information that CDRH director Shuren had attended AdvaMed board meetings, FDA refused to release details of Shuren’s calendar and meetings.
This raises another troublesome issue pertaining to trust: FDA’s increasing secretiveness since it acquired, along with all other government bodies, the ability to exclude the public, including or especially the news media, from its inner daily processes and personnel.
This came about after the 9/11 terrorist attacks and physical security was installed in all government buildings. Prior to this, anyone, including journalists, could just walk in and talk to anyone who wanted to talk to them.
A lot of management-unapproved internal information leaked out this way, feeding trade media with early, pre-decisional news about policy developments, personnel moves, incubating regulatory and enforcement initiatives, turf battles, rumors and gossip.
All that has disappeared.
FDA has been zealous in expanding its “security” screens far beyond the merely physical (bag searches, ID checks, metal detectors, etc.) to impose visitor escort rules under which nobody speaks to anybody without pre-clearance and active monitoring, mugshots, and electronic recording—all for your “protection,” of course.
In addition, all news media contacts, whether phone or email, are screened, diverted, or denied by so-called Public Information Officers for suitability and whether or not they will reflect credit on the agency.
IHP got access under the Freedom of Information Act to emails and documents that did not reflect credit on the agency.
Perhaps the screeners failed to see danger in the documents and emails they released.
I have had some of my requests delayed in processing so long they were useless in a news sense when the requested documents finally showed up years later, and even several that never showed up at all.
This, of course, never happens with requests from user fee-paying regulated industry.
Or does it?