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

Monday, August 24, 2015

Medical Implants are SEXY (and profitable)! FDA and Bad Ads.

By Sabriya Rice  | August 19, 2015
Since it launched in 2010, the U.S. Food and Drug Administration's “Bad Ad” campaign has received hundreds of complaints about potentially misleading or imbalanced drug advertisements.

Most recently it condemned a series of social media posts by reality TV star Kim Kardashian, in which she raved about relieving morning sickness with a pill she endorses.

But while drug marketing is subject to “Bad Ad” oversight, watchdog groups, clinicians and policy leaders say there's far less scrutiny for medical devices and other health services.

Modern Healthcare recently spotted an ad on the back of a bus in downtown Chicago that could be a good example.

“Diets don't work, get a lap band,” is the message from Dr. Fredrick Tiesenga, a surgeon with the Elmwood Park, Ill.-based weight-loss surgical center, New Hope.

Tiesenga supports the claims. Diets have about a 5% success rate for morbidly obese people, he said. “That's the same as the number of people who think Elvis is still alive. It's not really evidenced-based medicine to continue to send those people to dietitians.”

Though Tiesenga says the ad is intended for people with extremely high body mass indexes who have tried and failed multiple diets, others say the average observer wouldn't know that just by looking at the ad.

“It's misleading. He's making a definitive statement that diets don't work, which we know is not true. And it doesn't include any qualifiers,” said Dr. Bruce Lee, director of the Global Obesity Prevention Center in the Johns Hopkins School of Public Health.

Behavioral modifications, including dietary changes, are a major part of success after bariatric procedures, which cost, on average, between $20,000 and $25,000 in the U.S.

The worry is that those who are struggling with weight loss, upon seeing a message such as that might feel validated to ditch the diet, thinking they can eventually opt for surgery. “It's a very strong statement,” Lee said. “When I see an ad like that, I'm concerned about what the impact might be.”

Experts say misleading health information can be propagated as federal agencies continue to struggle with both the ability to monitor the deluge of ads and identify what counts as an advertisement.

The issue is not only complicated for federal regulators, but also for patients, said Dr. Yael Schenker, an assistant professor of medicine at the University of Pittsburgh. She coauthored a 2014 report in the American Journal of Bioethics that evaluated the ethics of advertising healthcare services.

“It's hard for people to figure out what is truthful,” she said. “It's very easy to mislead the public about something like healthcare where there is an imbalance in terms of access to information.”

To date, the FDA has received nearly 800 complaints through its Bad Ad campaign. It did not say specifically how many of those complaints ended in warning letters or corrective actions such as civil monetary penalties, injunctions and referrals for criminal investigation.

An FDA spokesperson said: "We don't track this metric, as the goal of the program is to raise awareness of misleading advertising and not to increase enforcement actions."

The FDA says complaints about medical devices are forwarded to the Center for Devices and Radiological Health, which enforces violations against federal ad regulations. The Federal Trade Commission may also take actions separately based upon its own jurisdiction.

But the article last year from Schenker and colleagues urged that without consistent oversight and standards, ads for general healthcare services continue to play on emotional, fear-evoking appeals that don't provide specific information about risks, benefits and costs.

Developing and enforcing new standards will not be easy, but the current health environment contributes to “an incoherent status quo,” they said, one where the industry is working to create high-quality medical systems while competing with marketing messages that might encourage patients to seek unnecessary care and dump clinicians who refuse to give it to them.

“We have to accept that advertisements are intended to be persuasive and are never going to present a complete or exhaustive list of risks or benefits,” Schenker said. “But there needs to be a unique set of criteria and oversight that is different from cars or cereal and other run-of-the-mill consumer products.”

For Michael Carome, director of the Health Research Group at the watchdog organization Public Citizen, the differences in advertising reflect a broader concern about pre-market FDA approvals, which are also different for drugs and devices. “The standards are much lower for devices than for drugs,” he said. “That dichotomy extends to advertising provisions.”

NHS in England: Medical device "hospitality" may land doctors in jail.

Jeremy Hunt: NHS bosses face jail over links to drug firms

By Tim Ross,   @TimRossDT  Senior Political Correspondent
10:00PM BST 22 Aug 2015
Senior medical staff will be forced to declare all gifts and hospitality they receive from drug companies or face the sack and the threat of jail.
In a major crackdown on corruption in the NHS, all hospitals and GP groups will be required to keep a register of hospitality and gifts from pharmaceutical firms to health service staff.
Jeremy Hunt, the Health Secretary, says he was forced to act after the Telegraph uncovered “disturbing” evidence of senior NHS managers being paid thousands of pounds and taken on expensive trips by firms lobbying to get their drugs used.
The transparency, or “Sunshine rule”, will be mandatory from next year and any member of staff who fails to declare full details of perks they receive will face disciplinary action.
If they are found guilty of wrongdoing – such as for accepting gifts or luxury foreign trips in exchange for influencing the NHS to buy particular products – they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail.
The NHS in England buys £7 billion of drugs each year, meaning that the taxpayer-funded health service is a lucrative business opportunity for drug companies and manufacturers of medical devices and equipment.
However, a report from Lord Carter earlier this year found huge variations in the amounts different hospitals pay for particular items –such as latex gloves or syringes - and in the cost and effectiveness of certain treatments, including varieties of replacement hips. This prompted concerns that billions of pounds was being wasted on inefficient systems.
Some NHS managers charged up to £15,000 to organise “advisory board” meetings for drugs companies – often in luxury hotels around the world, the investigation found.
Writing in The Telegraph today, Mr Hunt says it is "shocking" that thousands of sales reps are targeting the NHS. He says he has seen evidence that 65 reps were on site at one hospital at the same time.
Mr Hunt pays tribute to the Telegraph investigation for shedding further light onto the practice and uncovering “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”
A government report by Lord Carter found some hospitals paid 2p for one particular medicine, while one hospital spent £150 on a slightly different variant.
“Even worse, the Telegraph’s investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality," Mr Hunt says. "It’s hard not to conclude that some sales reps have ben ripping the NHS off, and diverting taxpayers’ money away from patient care.”
The minister says he does not want to stop “sensible” collaboration between private firms and the health service “but we must not tolerate abuse”. Only a tiny minority of staff have been accused of wrongdoing “and the overwhelming majority would be horrified” that drugs and equipment were being bought for any reasons other than that they were best for patients and taxpayers, Mr Hunt says.
The Sunshine rule is based on a similar initiative that was introduced in 2013 in America. The Department of Health said corrupt health staff would face disciplinary action, including the sack, and potentially prosecution which could result in fines or even jail.
The Human Medical Regulations 2012 ban the offering of gifts in connection with the promotion of medicines to anyone who is qualified to supply or prescribe medicines. Convictions under these laws can result in a two year jail term. Acts of bribery or fraud are covered by the Bribery Act 2010 and the Fraud Act 2006. Convictions under the Bribery Act can lead to up to 10 years imprisonment and an unlimited fine.

The Sunshine rule registers will be maintained by NHS hospital trusts, and Clinical Commissioning Groups, which oversee GP services and are responsible for purchasing drugs and equipment.

Sunday, August 23, 2015

New Zealand: Stryker strikes out with FAILED metal hips!

One woman's toxic surgery ordeal

9:55 AM Saturday Aug 22, 2015
David Fisher is a senior reporter for the NZ Herald.
Lynne McKay had both her hips replaced in 2007 with metal implants.
• The implants failed, causing her intense physical pain and violent mood swings.
• When the implants were eventually removed in 2012, a company representative attended the surgery and took photographs.
• A Health and Disability Commission investigation found no fault with McKay's medical care.
• About half the 5,000 metal hip implants given to New Zealanders have proved defective in some way but follow-up is left to the companies and surgeons involved.
"When I licked my lips I could taste metal," says Lynne McKay, who has had six hip replacements in six years. "There was a metallic film on top of the water in the toilet and I was having to clean it every day. I was peeing [metal] ions."
The new life she expected to come with her double hip replacement in 2007 never arrived. Instead came fears of madness and near-constant misery, which only partly abated when the metal hips were removed after being recalled as faulty in 2012.

The time in between was awful. Almost immediately, there was pain. Inside McKay's body, the connection between the ball and the cup created a "grinding" which produced an "ionic soup".
When McKay walked, she heard "click, click" as the ball ground against the edge of the cup. Unknown to her, there were "actual chips coming off the back. And the [metallic] dust". The joints - when they eventually came out - were abraded, ground and scratched.
Her body was "trying desperately to sort it out" by collecting the metal fragments into tumours around the hip area. "There was a tumour the size of a small hen's egg."
Then came other changes. "About two years after having my hips done, in hindsight, I started to experience toxicity."
McKay had yellow, green and blue curtains, which first dulled, and then lost their yellow tones. At first she thought the curtains were fading, then she realised she was losing her ability to see colours. She started to experience hearing loss and tinnitus, and had frequent unexplained rashes.
McKay thought she was losing her mind. "I couldn't hold a thought. I was always in tears. My words weren't coming out right. I was cutting my nose off with all my friends. I thought I had Alzheimer's. I really thought I was losing the plot."
With her life falling apart, McKay tried harder to keep it together. She walked the streets for hours doing letterbox drops to build a massage business, which was suffering. "I was desperate for work. I was begging people. I really lowered my professional life. I was fighting for my life on a lot of different levels without knowing what was going on."
Understanding arrived in 2012, when the Stryker Mitch THR (total hip replacement) System was subject to a recall notice. A blood test showed McKay had high levels of chromium and cobalt in her bloodstream. Normal levels are between zero and 20 microscopic nanomoles per litre. McKay had 326 nmol/l. Cobalt was also high - safe was 0-16 nmol/l but she had a 378 nmol/l reading.
Mackay believes her metal hips poisoned her. It's a belief shared by other implant patients with elevated cobalt and chromium readings. The British Medical Journal raised this in 2012 in a story on regulatory failure around metal-on-metal implants, saying the ongoing uncertainty around the impact of the metal ions would never be tolerated in drug regulation.
There is still argument in medical circles as to whether the high levels have any effect, even though concerns have been raised for more than 40 years. The official position is that the long-term effects are unknown.
For McKay, not knowing is unacceptable. She says efforts should be made to find out the effects of metal ions in her body, rather than adopting a "wait and see" approach.
But then, she's long lost faith that the medical system will listen to her.
Back when she was a believer, the former registered nurse anticipated life-changing results from the metal hips surgeon Rocco Pitto put into her body during surgery at Middlemore hospital in 2007.
She was 50 at the time and life had become increasingly painful. "I got to a place where I could only walk to the letterbox with two walking sticks."
Diagnosed with dysplasia, a condition in which abnormal growths form at the joints, she had both hips replaced in March 2007. In hip replacements, the femur is removed for an artificial replacement; in McKay's case, the metal stem was attached to a metal ball that moved inside a metal cup, mimicking the worn-out original.
The metal hip replacements were enjoying a resurgence in surgical popularity, with the belief they would be more durable and last longer than ceramic or plastic alternatives. But by 2010, concerns were raised widely about the safety of metal-on-metal with the recall of a DePuy-branded device.
In April 2012, the recall notice for McKay's device went out.
The Lancet medical journal raised the alarm with a study showing 6.2 per cent of implants had to be replaced five years after being put in. It compared to 2.3 per cent for ceramic-on-ceramic implants and 1.7 per cent for metal-on-plastic types. British figures showed McKay's implants - the Stryker Mitch THR System with an Accolade femoral stem - had a revision rate of 8.8 per cent over four years. The alert to surgeons in Britain included advice that they screen patients annually for the presence of chromium and cobalt in the body.
In New Zealand, documents released under the Official Information Act show Stryker initially wanted to class the notice as a "safety alert", saying it no longer distributed the device in New Zealand. Medsafe wrote back to say it did not agree and insisted the notice be classified as the more serious "hazard alert", effectively matching the British response.
The letter announcing the recall on the Mitch head went out to surgeons on April 13 2012. Under the New Zealand system, the state has no role to play in contacting surgeons.
Instead, the regulator - Medsafe - asks the medical device company to make contact with the surgeons to whom it sold the implants and for them to notify patients. The OIA papers show Stryker didn't hear back from all surgeons (who it calls "customers" in emails to Medsafe) who used the device until three months later on July 6 2012.
McKay believes her metal hips poisoned her. Photo / Jason Oxenham
In McKay's case, Pitto's recalls were handled through Middlemore Hospital. Furious at the impact on her life over the past five years, she says she developed strong feelings of anger and frustration towards Stryker.
She wanted to sue. She wanted justice: "I had asked for medical photographs to record the damage to my hip. The kids had started to tell me I needed to collect things for class action."
She wanted to get Stryker into court and sue the company for the grief it had caused.
When McKay went into surgery in July 2012, she says she had no knowledge of - and did not consent to - a Stryker representative being among the gowned and masked surgical team preparing to operate. She says she objected strongly and was even more upset on waking after surgery to see on her notes: "The representative of Stryker Medical was attending today's surgery and also took some photos."
McKay: "That's when I lost it. Those photos were my evidence of what had happened to me." The faulty parts were also removed.
Though Pitto later told a Health and Disability Commission investigation he did discuss consent with Ms McKay, the Counties-Manukau District Health Board has said he didn't need her permission to have a Stryker representative in surgery and didn't ask her. The board also told the Herald - and Ms McKay says it's the first she's heard - that the Stryker photographs were not of the surgery but only of the faulty parts, removed from her body. She can't see the images to assure herself - the board says Stryker has deleted the photographs.
There are no signed consent forms showing permission was granted for either Stryker's presence, or the company's decision to take photographs or for the removal of the faulty parts. In all those cases, the health board says no consent was needed. It says consent is not required when someone is part of a surgical team.
For McKay, it felt as if the system was aligned against her - and even aligned with the company she blamed for the faulty part
In the end, McKay had a further three operations - a total of four hip replacements in 13 months after the recall. The replacement of the first metal hip in July 2012 was a failure - it dislocated less than two months later and needed replacing in November 2012.
One foot after another, neither working properly, "I fought to keep moving," says McKay. The replacement hip went in backwards so was replaced again on May 29, 2013. And then it was the other side. The right hip was revised in August 2013 and she then went into recovery for a year, getting $257 a week from ACC with a small accommodation top-up. Now, at least, "the metal taste was gone and energy levels were back up. But I'm in constant pain." She hisses with frustration.
"I'm sick of saying that actually. I walk like a drunk woman. I've no sense of stability in my hips. It hurts me to walk upstairs. My body is managing the indiscrepancies in core balance muscles but I pay for it in other ways. The body reorganises itself around weak muscles.
"I'm back massaging but I have to do it differently. I do my gardening and my housework on my knees."
McKay doesn't want anyone's sympathy. She's angry with nothing to strike out at. A complaint to the Health and Disability Commission talked of the "benefit of hindsight" and said Pitto's professional practice was appropriate given the knowledge at the time. Pitto declined to speak to the Weekend Herald.
And that's it. The metal hips that went bad inside her body were never approved for use in New Zealand, because our system doesn't require approval for medical devices.
The surgery took place largely in public hospitals, paid for with public money, and the taxpayer has since supported her recovery with a (meagre) salary supplement. ACC has never kept track of how much it cost the public to cover surgery to replace defective products or to cover rehabilitation afterwards.
No public body is taking action to discover the extent of the issue and whether it could have been handled better. When a group of Kiwi patients set off to Britain courts to unsuccessfully sue Stryker for negligence, they did so without Government support.
A spokeswoman for the Counties Manukau District Health Board pointed to a Health and Disability Commission investigation which found "the care provided to Mrs McKay was appropriate in the circumstances.
The DHB acknowledges the distress and pain that Mrs McKay has suffered as a result of the metal on metal hip implant and apologises that she had to undergo further surgery to replace the device."
A spokeswoman for Stryker said the company had "strict policies" guiding the behaviour of its staff in and out of operating theatres and investigated any complaints against them. The company would not provide a copy of its policies and would not comment on the specific case.
The scale of the issue is difficult to gauge. A Medsafe briefing counted about 1200 metal-on-metal devices that were recalled or subject to hazard notices. A further 1300 metal-on-metal devices had failure rates so high that surgeons were advised to check on their patients regularly.
In some cases, the surgeons who carried out the operations have died or retired - Medsafe's hope is that their successors will reach out on their behalf.
Health Minister Jonathan Coleman's office hasn't had any briefings on the issue in the past two years.
A spokeswoman says the regulatory system worked as it was meant to - but that system is about to be completely overhauled. "Health care is always rapidly changing, including emerging technologies, and we need to look at how legislation can better support that."
A law for the new regulatory scheme is expected to be put before Parliament next year and will "regulate the quality, safety and efficacy/performance of all therapeutic products across development and manufacture, market entry, and use".
Among the patients given the 2500 implants that were never good enough, McKay and a small cluster of unknowns have had extreme adverse experiences.
"I worry about what the future holds after being toxic for so long," McKay says. "Sometimes you just have to suck it up and get on with it - but somebody should be accountable."

Implants approved before risk known

Metal hip implants were recognised as a risk to patients after they were approved for use, says a surgeon who advised the Australian Government on the technique.
Surgeon Peter Devane - a hip replacement and revision specialist - says metal implants and metal caps on affected joints grew in popularity through the 2000s although use varied around the world. New Zealand was more conservative than most.
Devane was part of the system that cleared the devices for use in Australia. Between 1998 and 2008 he sat on the orthopaedic committee of Australia's Therapeutic Goods Association, the body that advises government on which devices can be used. The Australian system approved products under guidelines developed by the Global Harmonisation Task Force, a collection of volunteer regulatory bodies and medical device companies from around the world. At the time, metal-on-metal hips were in the "2b" category which meant they faced few regulatory hurdles because they were considered to be a modification of a previously-approved product.
From about 2007, work began to upgrade the categorisation to reflect a higher risk, but metal-on-metal hips had already gone through. Devane says governments were left playing catch-up. A British Medical Journal article later labelled it regulatory failure.
In New Zealand, the use of the products peaked in 2007. "Then those reports on metal-on-metal started coming out. We were aware of them - regulatory bodies were aware of them. By 2010, metal-on-metal was down to 3 per cent (of hip replacements)."
The comparative low number of replacements here - about 5000 replacements - tempered the surgeons' responses. "We didn't want to create a panic culture because it's not as big a problem (as abroad)," says Devane.
New Zealand's regulator Medsafe doesn't have an "approval process". In a statement, it told the Herald: "The [New Zealand] legislation does not require any form of pre-market assessment of medical devices." Medsafe takes guidance from other regulatory authorities -including the TGA - while medical device companies sell direct to surgeons.

Medsafe has "no mandate to approve medical devices or to monitor their import into the country", the statement said. Instead, companies are obliged to register devices on a database. "A notification on the database does not signify that a medical device has been 'approved' in any way."

Friday, August 21, 2015

Reasonable jury verdict: J&J pays $3M for surgical mesh patient harm

No retrial for Ethicon in $3m pelvic mesh loss


A federal judge today shot down a bid by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial.
A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.2 million, finding in September 2014 that Ethicon’s TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.
Ethicon asked Judge Joseph Goodwin, who’s overseeing 10s of thousands of product liability lawsuits brought over pelvic mesh products, to overturn the verdict or, alternatively, to grant a new trial.
But Goodwin today declined to disturb the jury’s verdict, finding that “[t]he evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”
A reasonable jury, Goodwin ruled, could conclude that the risks of the TVT-O product “are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product.”
“In short, while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the TVT-O’s high risks of injury and how Ethicon could have mitigated those risks through alternative designs,” Goodwin wrote, according to court documents. “Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon. As a result, I cannot displace the jury’s verdict on these grounds.”
Goodwin also cited evidence produced at trial that Huskey’s physician would not have used the TVT-O device had she been warned that it was contra-indicated for active patients like Huskey. The doctor was also unaware of other risk factors from the product, the judge ruled, including that the mesh itself could cause infection and that the amount of mesh material in the product could cause more complications.

“The plaintiffs presented sufficient evidence on Ethicon’s knowledge of dangerous propensities of the TVT-O and failure to warn about those propensities such that a reasonable jury could conclude that Ethicon was negligent,” Goodwin wrote.

Thursday, August 20, 2015

Forbes: FDA Approval MEANINGLESS!

The FDA Is Basically Approving Everything. Here's The Data To Prove It

Matthew Herper  AUG 20, 2015 @ 5:53 AM 
Remember when the FDA rejected drugs?
We just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.
As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.
Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.
The way BioMedTracker follows new molecular entities is slightly different from the FDA does. BioMedTracker users want to know about every use of a new medicine. That means that the 2015 rejection count includes rejections of Avycaz, a new antibiotic from Allergan ngIf: ticker AGN -1.27% ngIf: show_card end ngIf: ticker , for hospital-acquired pneumonia, and selling Jardiance, a diabetes drug from Eli Lilly ngIf: ticker and Boehringer Ingelheim ngIf: ticker , in combination of metformin. But Avycaz was approved for two other uses and Jardiance is on the market by itself.
So in reality, the FDA approval rate is more like 96%. Eliminating BioMedTrackers counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ngIf: ticker ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.
But it’s worth sticking to BioMedTracker’s definitions, because it allows us to compare this incredibly high approval rate with the past. And that tells a story of an agency that has been giving the green light more and more often.

In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%. In 2009, the NME approval rate fell to 44%, as 28 uses were rejected and 22 were approved. That rate rose to 86% in 2011, partly as some of those rejected drugs reached the market, fell again to 60% in 2013, and in last year rose to 88%. The evidence is that we’re living in a golden age of drug approvals, at least from a drug company’s perspective.
And there’s even more data to back up the contention that the FDA is basically providing a rubber stamp. BioMedTracker doesn’t just track what happens to NMEs, or new drugs. It follows closely every time a company asks the FDA for an approval. (One flaw in the data: while drug approvals are a matter of public record, we only know about rejections, known by the euphemism of “complete response letters,” if drugmakers feel the need to share them publicly.
For this analysis, BioMedTracker also looked at every time that a company asked the FDA to either approve a new drug or approve a new marketing claim for an existing medicine. The numbers parallel what was seen with brand new medicines.
In 2008, companies asked for 134 approvals and got 75 of them, a 56% approval rate. That rate hovered steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%, with 97 out of 126 requests for approval coming back positive. This year’s approval rate? It was 88%.
Again, nine out of ten times, when a pharmaceutical company asks the FDA for a new marketing claim, it gets it. That’s why all of the arguments about Addyi, whose maker, Sprout Pharmaceuticals, is now being bought by specialty pharma giant Valeant Pharmaceuticals ngIf: ticker for $1 billion, were a little silly. The odds of a rejection were low at best.
The FDA points out that one reason that drug approval rates are going up is because it is doing its job, as defined by Congress. The agency has deadlines for when it is supposed to approve new drugs, and it is meeting them. More than that, it has instituted new procedures to make sure it communicates well with drug companies before they file new drug applications. And the FDA has had a program to ask patient advocates what they want. Many sick patients would prefer that the FDA approve a drug with a marginal benefit than reject it.
Right now, it only looks like this trend will continue. A new bill called the 21st Century Cures Act attempts to further speed up approvals and remove red tape.
But the risks of speeding up approvals should be pretty clear, too. In the late 1990s and early 2000s, there was a boom of new drug approvals. In 1999, the FDA approved two drugs that became synonymous with drug safety scandals: Vioxx, which was withdrawn from the market by Merck, and Avandia, made by GlaxoSmithKline, which later had its use severely restricted. The approval boom is good only so long as it doesn’t trigger another drug safety conference.
That’s why we should tread carefully here. Already, the FDA is approving drugs almost all the time. It is doing so rapidly, with appropriately lower standards for rare diseases. How low do we want the bar to go?
And it seems appropriate to also give a warning to biotechnology investors. For any drug facing an FDA decision in the near term, this is good news. Worried about whether the muscular dystrophy drugs being developed by Sarepta and Biomarin will be approved? The odds are probably better than you think.
But we’re also living through an unprecedented biotech boom, with the iShares Nasdaq Biotechnology Index up 360% over five years in part because the regulatory environment for drug companies has improved. Well, this could be as good as it gets. If 96% of new drugs are getting approved, approval rates can only go down. If you’re looking for an indication that we’re hitting a peak, this could be it.
And I think it’s likely that the current approval rates are as much a result of the political environment as anything else. To the extent that they think about the FDA, politicians on the right generally want the FDA to get drugs to patients faster, giving them choices. Those on the left worry more about approving dangerous drugs.

But the FDA doesn’t follow the tone set by the President or the party in power, because the FDA is never the center of anybody’s agenda. Instead, its tendency, even if its unconscious, is to protect itself against attacks from the opposing party. A lame duck Democrat and a Republican Congress? You’re going to get an easy FDA. If a Republican wins the White House next year, think about selling your drug stocks.

I posted the article on my Facebook page with this comment:  

Thank you, Helen Haskell for sharing this article. I was trained 9/2010 at FDA/CDRH to be a Patient Representative. I have NEVER been contacted to serve on an AdvisoryPanel. Patient Representatives are NON-VOTING and most devices are cleared as 'substantially equivalent' 510(k)-grandfathered. I would like to see a similar report on medical devices and have a requirement that this information be a part of 'Informed Consent' for the patient.

Monday, August 17, 2015

Sacrificial lambs! U.S. Senate: AMEND 21st Century Cures Act

  • OpEd by 

    • A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?
    I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
    In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
    When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
    Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
    These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
    That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
    The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
    Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
    Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
    The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
    What are patients to do?
    First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
    ■ What is the implant's failure rate?
    ■ How does the tissue react around the implant?
    ■ If the implant fails can it be taken out?
    I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
    Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
    Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (
    If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(
    Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
    For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
    Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
    According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
    Almost everyone has a stake in health-care policy regarding implants.
    We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
    Dr. Kevin Kavanagh of Somerset is board chairman of Health Watch USA.

    My comment:  I trained 9/2010 at FDA/CDRH as a Patient Representative.  In 2008 my brother was implanted with a Tornier elbow that was designed by the Mayo Clinic surgeon that performed the implant.  The elbow failed(pain and loss of function) and was 'revised' by removing two of the components . . . yet it was not reported to the FDA as an adverse event.  Multidistrict lawsuits (MDL's) for metal-on-metal hips(100,000) and pelvic surgical mesh(75,000) have begun to prompt anemic settlements for the PREVENTABLY, severely and permanently harmed patients.  Implanted elbows are rare (@4,000 annually) and can be considered an 'orphan' device and lawyers have little incentive to bring a lawsuit.  The surgeon is not legally required to report an AE (adverse event) unless there is a fatality and the FDA does not investigate anyway.  If patients knew the catastrophic downside and actual patient outcome statistics on implants they would demand the medical device implant industry provide a product warranty on permanent implants.  Marketing statements should align with patient outcomes.  The 21st Century Cures Act is an affront to public health and all the SACRIFICIAL LAMBS that Dr. Kavanagh refers to.  

Wednesday, August 12, 2015

The FDA/CDRH FAILURE: unsafe & ineffective high risk devices cause PREVENTABLE patient harm

Evidence Limited for Most High-risk Device Approvals

Marcia Frellick
August 11, 2015

The quality and amount of evidence used by the US Food and Drug Administration (FDA) to support bringing high-risk devices to market varies greatly, new research indicates.
A study by Joseph S. Ross, MD, MHS, from the Yale University School of Medicine in New Haven, Connecticut, and colleagues, published in the August 11 issue of JAMA, found that nearly all devices the authors studied from 2010 to 2011 were cleared on the basis of two studies: one pivotal study (studies that served as the basis of FDA approval) and one nonpivotal study. Nonpivotal studies are typically conducted to assess device feasibility, enrolling a limited number of patients to examine performance and guide premarket development and clinical use.
"[M]ost devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication," the authors write.
In the United States, the FDA most often grants marketing approval through the premarket approval pathway for high-risk medical devices, which the authors describe "as those that support or sustain human life, prevent illness, or present potential, unreasonable risk to patients."
The premarket approval pathway requires that premarket clinical evidence provide reasonable assurance the device is safe and effective.
The FDA has been expediting patient access to new technologies by being more flexible with premarket evidence requirements for devices, but concerns have been raised that the studies supporting approval lack adequate rigor and are prone to bias.
The current study shows that between 2010 and 2011, the FDA granted initial marketing approval for 28 high-risk therapeutic devices through the premarket approval pathway.
Ten of those devices (35.7%) were recalled at least once, with 1 (3.6%) being the subject of a class 1 recall, meaning it presented the highest risk (reasonable probability of serious health problems or death). One device was voluntarily withdrawn from the market.
Emphasis Shifts to Postmarket Studies
"As the FDA adopts more flexible premarket evidence requirements for devices in an effort to expedite patient access to new technologies, the information generated from post market studies will become increasingly important in guiding regulatory and clinical decisions," the authors write.

However, they note that only about 13% of postmarket studies were completed between 3 and 5 years after FDA approval.
No postmarket studies were identified for 17.9% of devices, and three studies or fewer were identified for 13 (46.4%) of devices overall.
"Our findings of limited premarket evidence generation and few FDA-required postmarket studies highlight the need for continued study, either through manufacturer-initiated or investigator-initiated studies, to advance postmarket understanding of device safety and effectiveness," the authors write.

About 85% of the postmarket studies the authors identified "were not initiated in response to FDA requirements, and 40% were conducted without manufacturer support."
Dr Ross has received grants from the Pew Charitable Trusts and is supported by the National Institute on Aging and the American Federation for Aging Research. He and a coauthor receive support through Yale University from Medtronic and Johnson & Johnson; from the Centers of Medicare & Medicaid Services; and from the FDA to develop methods for postmarket surveillance of medical devices. Another coauthor is supported by the National Heart, Lung, and Blood Institute Cardiovascular Outcomes Center. Another coauthor reports he chairs a scientific advisory board for UnitedHealthcare. Another reports having received a contract (through the University of Colorado) from the American College of Cardiology.

JAMA. 2015;314:604-612. Abstract

What is the quality ranking of your surgeon? Why can't you find out?

Why is it so hard to know how good a doctor is? 

  AUG 10, 2015   (WNPR 48 minute audio program)
There are lots of tools to help us gauge the quality of nearly any product or service we wish to buy, from cars to computers to restaurants. Yet there's no easy way to assess the quality of the doctors who take care of what's most important to us -- our health. 
The Journal of Patient Safety reports that at least 200,000 people die each year from preventable medical errors, up from 1999 when a landmark report, "To Err Is Human," told Americans that more people die every year from medical errors -- 98,000 -- than from car accidents.  
Yet, more than a decade later, many hospitals still don’t track the complication rates of individual surgeons -- or if they do, few hospitals share information that could help consumers make an informed decision. 
Investigative journalists at Pro Publica set out to do what many hospitals are not: examine the data of nearly 17,000 surgeons nationwide to force improvements in the 11% of surgeons who account for about 25% of the complications. But their “surgeon scorecard” has its critics, who say the methodology is flawed, and the data not comprehensive enough to measure the true skill for any single doctor.
Hospitals have had a long time to work on this problem. At a time when data is abundant and the call for transparency is loud, are hospitals ready to open this conversation?
If you've been harmed by a medical error, you can access Marshall Allen's questionnaire here.
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John Dankosky is the host of Where We Live. Chion Wolf is the technical producer.