FDA Could Be Sustainable AND PREVENT Harm

The FDA Could Earn Over $60 Million A Day From Enforcing The Law

Stuart Buck

October 14, 2015

Many clinical trials on medicines and devices are subject to a 2007 federal law that requires the results to be publicly disclosed on a federally sponsored website within a year after the clinical trial is over. The reason for this requirement is simple: to give doctors and patients full information so that they can make educated decisions about a given treatment. If disappointing clinical trial results remain hidden, while only the most positive results are published and presented in the media, doctors and patients can be wildly misled.

Unfortunately, investigators have found that over half the time, clinical trial sponsors fail to abide by the law, sometimes failing to disclose results even after five years have elapsed. Even more unfortunately, the Food and Drug Administration (FDA) has never once imposed the legally authorized $10,000-per-day fine for failure to disclose a clinical trial’s results.

Compliance With Reporting Requirements

The most recent investigation was published in the New England Journal of Medicine (NEJM) in March 2015. The authors identified 13,327 clinical trials that were registered on ClinicalTrials.gov, that were completed between 2008 and 2012, and that were subject to the 2007 federal law requiring full disclosure. A mere 13.4 percent of the clinical trials actually disclosed their results within the 12 months required by law, and even after up to four years had elapsed, only 50.5 percent had disclosed the results or asked for a delay (see Figure 2 in the NEJM article).

In a twist that ought to embarrass academics, industry-funded trials were more likely to disclose results than the National Institutes of Health (NIH)-funded trials, which were in turn more likely to disclose results than academic medical centers. The authors found 6,599 clinical trials that were overdue on reporting results.

Increasing Fda Enforcement

If the FDA imposed a $10,000 per day fine on each of these 6,599 outstanding trials, clinical trial sponsors would be responsible for $66 million in payments in the first day alone, adding up to over $24 billion per year.

Although the $24 billion figure shows the size and scope of the problem, the collective fines would never reach that amount because as soon as the FDA actually begins enforcing the law, the researchers who conducted these 6,599 trials would finally be incentivized to report the trials’ results.

Why doesn’t the FDA enforce the law? Some have argued that ClinicalTrials.gov is an antiquated and difficult-to-use website. True enough, but given that 38 percent of trials do disclose their results at some point, it is clearly not impossible to do so. This is not a reason to leave the federal law completely unenforced.

The NEJM article states that one reason for lack of enforcement is that a new rule on clinical trial report is still pending. But the 2007 law itself requires basic reporting of results; the only point of a new rule is to expand the requirements to include other items, such as protocols. The mere fact that a rule may be expanded in the future is no reason to leave the current requirements unenforced. Yet another possibility is that the FDA does not want to get bogged down in lawsuits from companies or universities that have a valid reason for delay. But this argument would suggest, at most, that the FDA ought to levy a fine only when truly merited, not that the FDA should never enforce the fine at all.

My proposal: as an experiment, the FDA should give the 30-day notice required by statute, and then set aside a single week in which it will levy the $10,000-per-day fine on all overdue trials. Assuming that there are around 6,600 overdue trials that don’t come into compliance within the 30-day grace period, the FDA would end up imposing over $460 million in fines within a week’s time. In so doing, it would make a strong statement that disobeying the law and hiding clinical trial results is no longer acceptable.

And within a week, compliance with the law would likely shoot up astronomically, and we would have more complete knowledge about how well or how poorly drugs actually work. In turn, we could all make better decisions about how to improve our nation’s health.

http://healthaffairs.org/blog/2015/10/14/the-fda-could-earn-over-60-million-a-day-from-enforcing-the-law/

If my knees were a car, my mechanic would choose my next automobile!

Landers: Knee replacements make for strange healthcare economics

Jim Landers

jlanders@dallasnews.com

Published: 12 May 2014 09:15 PM

Updated: 12 May 2014 09:44 PM  FiDA highlight

WASHINGTON — This winter, I had my knees replaced. I used a surgeon and a hospital in my neighborhood of Alexandria, Va., not far from where I work. The surgery and rehab are going fine. The lessons in health care economics are becoming strange.

For each knee, the bills (hospital, surgeon, anesthesiologist) came to roughly $32,000. Michael Toomey, president of Compass Care Engineering in Dallas, says the average in the Dallas area is between $42,000 and $43,000.

My new mechanical knees were the most expensive items in the bills. The hospital wanted $16,097.05 for each of them. My insurance agreed to pay $10,982.72 apiece.

These are Sigma System knees, size 5, made by DePuy Orthopaedics of Warsaw, Ind. DePuy is part of Johnson & Johnson.

The knees are made of cobalt, chrome and polyethylene. There’s a buckle-like piece that fits over the knee tip of my thigh bone. There’s a piece that looks like a peg with a circle on it drilled into my shin bone. Between them is a plastic disc. On the back of the knee cap, there’s a metal dome.

My surgeon chose these knees. The hospital bought them. Insurance (and my out-of-pocket max of $3,000) paid for them.

So, let’s see, if my knees were a car, my mechanic would choose my next automobile. A garage would buy it, and add its own markup. My employer (which is where I get health insurance) would pay for most of it, using an insurance administrator to bargain over the price.

Survey of surgeons

This is standard practice in the medical world. Device manufacturers will pitch their products to surgeons, but the surgeons are often in the dark or heedless of the cost. A survey cited in the January issue of Health Affairs found that 81 percent of orthopedic surgeons could not accurately guess the cost of these devices. And American surgeons replace about 720,000 knees a year.

Baylor Scott & White Health is using a different approach. The surgeons and the supply people meet to talk openly about prices and quality. They agree on a price the hospital system will pay. Medical device makers are then invited to meet or beat that price.

“Everybody can play, but you have to meet this capitated [maximum] price,” said Pam Bryant, Baylor Scott & White’s senior vice president for supply chain services.

Surgeons can choose among four or five key types, Bryant said.

Texas Health Resources also negotiates as a chain for its joint replacements. But here, the surgeons can choose what they like.

“While there is a great deal of similarity between devices, surgeons have definite preferences based upon training and their individual style of surgery — as well as the individual patient needs, including age, activity and other factors,” said John Gaida, THR’s senior vice president for supply chain management.

“Texas Health strives to make virtually all brands of hip and knee implants available to our surgeons so that the patient needs are always the primary consideration,” he said.

Across the country, surgeons are not clued in on the cost of medical devices often because the hospital can’t share that information. They typically sign a contract with the medical device company that forbids disclosure.

Doctors order

I know little about mechanical knees. My surgeon implants them all the time, so it makes sense to follow his guidance on what would suit me best and last longest.

But we didn’t go over a list of knees and manufacturers. My surgeon asked about my lifestyle, looked at my age and weight, and chose for me.

The hospital did the negotiating with DePuy. Did they get a good deal?

A 2012 Government Accountability Office report covering a small sample of hospitals found that one paid $5,200 for a knee replacement while another paid $9,500 for the same device.

There are several types of knees on the market. There’s a standard, fixed-bearing knee; a rotational knee that can handle more twists and turns; and a rotational/full flexion knee that allows for deep squats.

Prices seem to run between $2,000 and $16,000 for the device. So it turns out that my new knees (rotational) are pretty high-end. I hope they last a long time.

Follow Jim Landers on Twitter at @landersjim.

Medical device industry is "unlike" just about any other consumer industry!

About 80 percent of hip doctors haveno idea how much a hip replacement costs

            BY JENNY GOLD   Washington Post  Wonkblog

            January 7 at 10:20 am

What will a gallon of milk set you back? How about a new car? You probably have a rough idea.

But what about a medical device, the kind that gets implanted during a knee or hip replacement? Chances are you have no clue. And you are not alone: The surgeons who implant those devices probably don’t know their cost, either, a new survey shows.

Medicare spends about $20 billion each year on implantable medical devices, nearly half of it for orthopedic procedures. And as the population ages and more Americans get joint replacements, that number is only going up, which will have a bigger and bigger impact on the nation’s health care spending.

But orthopedic surgeons don’t know much about how much their work contributes to that spending. They were able to correctly estimate the cost of a device only 21 percent of the time, according to a survey of 503 physicians at seven major academic medical centers published this week in the journal Health Affairs. Their guesses ranged from 1.8 percent of the actual price to 24.6 times the actual price. (Researchers could not release the actual costs because they signed nondisclosure agreements with the hospitals.)

Medical residents were worse at guessing — they were correct only 17 percent of the time. Estimates within 20 percent of the actual cost were considered correct. The study did not look at what patients know about cost.

“In orthopedic surgery, we’re never told how much things cost. We never see the cost displayed anywhere, and even if you were interested, there’s no great way to find it,” says Kanu Okike, lead author of the  study and an orthopedic surgeon at Kaiser Permanente Moanalua Medical Center in Honolulu (Kaiser Health News is not affiliated with Kaiser Permanente).

Unlike pretty much every other consumer industry, health care costs are not transparent, even for the surgeons. Each hospital system and purchasing group negotiates deals with device manufacturers and signs a nondisclosure form, promising not to share the details of those prices with anyone else.  That’s because “medical device manufacturers strive to keep their prices confidential so that they can sell the same implant at a different price to different health care institutions,” the study authors write.

But costs matter: For a total knee replacement, the actual piece of machinery that gets implanted can cost from $1,797 to $12,093, depending on the negotiated price. And there’s little evidence that one particular device is any better than another for the patient, says Okike.

The hospital actually has a financial incentive to use cheaper devices — it’s paid a lump sum for the procedure by Medicare (the government’s health insurance program for seniors and disabled people). That means that if a hospital uses a cheaper device, it ends up with a bigger profit.

But hospitals don’t tend to pressure surgeons to use the cheaper device, says Kevin J. Bozic, an orthopedic surgeon at the University of California San Francisco who studies the cost of medical devices. That’s because orthopedic surgeons are big moneymakers. “They don’t want to offend the doctors. They cater to them however they can, which includes not telling them which devices to use,” he explains.

And many orthopedic surgeons are aligned with a particular manufacturer, says Bozic, and receive a consulting fee or royalty for using that particular device. That makes them even less likely to take cost into consideration.

Some hospitals are seeking to make the devices' pricetags more transparent, in the hopes that just knowing what things cost will encourage surgeons to make different choices and lower spending. There are some glimmers of hope, including a national pilot project that makes a surgeon’s payment for each surgery dependent on the cost of the devices they use.

“But at the root of it, the biggest problem is the lack of price transparency across the industry,” says Okike. And device manufacturers aren’t in a hurry to change that without some sort of pressure.

Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.

Failed implant Device Alliance (JjrkCh) comment: 

Consumers must ask the orthopedic surgeon "What is the brand/model you are implanting?" and get a UDI- unique device identifier code.  "What is the warranty for this implanted product?"  "What are the validated clinical (live human) studies of patient outcomes from this specific implanted device?"  So far, the medical device industry has avoided accountability while gaining federal legal entitlements because of the ease of clearance by the FDA.  (The public believes there is a "regulator" for safety and effectiveness.)  If "informed consent" included this information, clarifying the loss of basic civil rights of the harmed patient, there would be no reason to discuss cost.  Who would purchase a car or a toaster this way?  My blog is Failed Implanted Device Alliance.  It compiles information about the safety and effectiveness issue.