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Pharmaceutical Industry

Pay More, Get Less

  • By
  • Joshua Freedman,
  • New America Foundation
April 30, 2014
The American middle class faces an uncertain future. Staring headlong into a difficult – and changing – world economy that has yet to fully recover from the Great Recession, many middle class families are trapped between low, stagnant wages and an increasingly expensive set of social and economic supports.

Meningitis deaths could have been avoided

December 18, 2012
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This op-ed is co-authored by Jeff Borkan, Chair of the Department of Family Medicine at Brown University School of Medicine.

The media attention and Congressional investigation into the tragic epidemic of spinal meningitis in people who had injections for back pain has focused on unsanitary conditions at the compounding pharmacy that produced the medications. At last count 620 cases and 39 deaths have been confirmed in 19 states because the steroids used in the injections were contaminated with a common fungus. Yet remarkably little has been said about the underlying cause of this tragic outbreak -- the widespread overuse of an unproven procedure (epidural steroid injections) that put the contaminated steroids into the spinal cords of patients in the first place.

The procedure involves inserting a needle into the spinal canal, one of the most vulnerable parts of the human body, and then injecting steroids, which are supposed to reduce inflammation and allow the back to heal. Each year, more than 9 million Americans are treated with spinal steroid injections, and one study found that the number of Medicare recipients undergoing this procedure increased by 159 percent between 2000 and 2010.

How did steroid injections come to be performed so often? Patients assume that most medical treatments are supported by years of careful studies. They think any invasive procedure that might put them at risk of harm is performed only by trained and certified physicians with rigorous clinical oversight.

In the case of spinal steroid injections, nothing could be further from the truth. There is no widely accepted guideline for the use of epidural steroids, and the U.S. Food and Drug Administration has never specifically approved steroids for that use. There is scant medical evidence to show that the use of epidural steroids is any more effective at relieving back pain than routine, conservative care or even sham (fake) injections. There are many possible side effects of this procedure, and while the most serious complications are rare, they can be disabling or life threatening. Yet this unproven, risky treatment is routinely offered on an outpatient basis by physicians who have widely varying levels of training and expertise. While most of those physicians undoubtedly believe they are acting in their patient’s best interest, there is no escaping the fact that they are paid nicely for a procedure that takes only a few minutes to perform.

There's no doubt that regulators should go after the makers of unsafe medications. Slipshod manufacturing practices can't be tolerated when people's lives are at stake. At the same time, we need to rethink our willingness to pay for procedures and tests that have known risks and unknown benefits. Epidural steroid injections are just one of myriad examples of such treatments, and taken together, the overuse and misuse of medical procedures is costing us dearly, both in terms of wasted dollars and wasted lives. It’s time to build a health care system that serves patients rather than profits, and the first step is recognizing tragedies like the spinal meningitis outbreak for what they are, cases of overuse.

For Your Thursday Enjoyment: Health Wonk Review!

August 16, 2012
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Hosted this week by Dr. Jaan Sidorov at the Disease Management Care Blog, it's "A Brainy Health Wonk Review on Health Reform, the Affordable Care Act and Lots More!" Go check it out.

Health Wonk Review will be back on September 13th, hosted by Louise Norris of the Colorado Health Insurance Insider Blog.

Advanced Screening of "Escape Fire" in NYC

July 26, 2012
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On Friday August 6th, the New America Foundation will be hosting an advanced screening of "Escape Fire: The Fight to Rescue American Healthcare." The event will take place in New York City from 6:30pm-8:30pm. Watch the trailer here.

Directed by Matthew Heineman, “Escape Fire” is a stirring documentary about the perilous situation of our current healthcare system, and what can be done to fix it. The film, which has been honored at both the Sundance Film Festival and the Full Frame Festival, is being screened nearly two months before it comes out in theaters. More details, as well as a link to RSVP, are available here, at the event's page:  "Escape Fire - Screening Event"

Drug Regulation, Symbolic Votes, and Hospital Safety

July 16, 2012

Here's our wrap-up of last week's articles by our own Shannnon Brownlee and Joe Colucci:

Letting Big Pharma Review Its Own Drugs — What Could Go Wrong? (The Atlantic Health Channel):

Earlier this month GlaxoSmithKline agreed to pay a record breaking $3 billion fine for a slew of criminal and civil violations. But is a fine really enough? In a piece in The Atlantic, Shannon Brownlee and Joe Colucci argue that we need to stop letting drug companies track the post-market safety of their drugs and establish an external automatic review system. 


12 Ways Health Care Could Be Improved If the House Wanted to Hold More Than Symbolic Votes (The Atlantic Politics Channel):

In the wake of the House's 33rd vote to repeal/defund Obamacare, Joe and Shannon propose a list of 12 things the House could have done to make a better use of tax payers' dollars and actually improve health care. In the article in The Atlantic the proposals range from enacting a less intrusive mandate to funding after school programs to teach kids how to cook. Any of them would have worked better than another "symbolic vote."


Why The ‘Best’ Hospitals Might Also Be The Most Dangerous (TIME Ideas):

We've all seen them—the U.S. News Rankings of everything from colleges to cars. How do their hospital rankings look? In her latest article for TIME, Shannon argues that, based on new rankings by Consumer Reports, many top-name hospitals fail to measure up in terms of safety. Hospital rankings would be a lot more useful if they considered how medical care affects most patients, not whether a hospital performs some cutting-edge procedure on three patients per year.

We need universal Phase IV clinical trials!

July 5, 2012
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PharmedOut, a project of the Georgetown University Medical Center, had its third annual conference a couple weeks ago in DC. The meeting was called “Missing The Target: When Practitioners Harm More Than Heal,” and it addressed some of the most important issues in health policy—issues that have been disturbingly absent from the public discussion. While the news media and members of Congress have spent the last several years discussing insurance coverage (or, more often, what the most recent vacuous coverage-related talking point means for the political horse race), issues of patient safety have been left on the sidelines. The PharmedOut meeting was a welcome opportunity to return to focusing on patients.

One of the most compelling moments came during Dr. Amy Friedman’s talk. Dr. Friedman is a transplant surgeon, and frequently speaks to groups of surgeons. She asks them a number of questions during these presentations—her favorite of which is “True or false: All medical devices used in the US have been proven safe and effective.” A large majority of the surgeons she talks to know that the answer is “true.”

The trouble is, of course, it’s not.

I can understand members of the public getting that wrong--after all, the Food and Drug Administration is responsible for making sure that all foods, cosmetics, pharmaceuticals, and medical devices are safe, and that the latter two are effective. But it's inexcusable for doctors to be so ignorant of the weaknesses in our regulatory system.The fact is, there are gaping holes in device approval processes, to the extent that many medical devices in use today have never been tested for effectiveness.

When the FDA started regulating medical devices in 1976, the agency established rules that assumed any device already in use was  safe and effective (unless it was already known not to be), and those devices continued to be sold. That grandfather clause included a number of basic and obviously safe devices, like tongue depressors and scissors, but it also covered higher-tech devices like the implantable pacemaker (invented 1958).

The FDA also waives testing requirements for "low or moderate risk” devices that are "substantially equivalent” to devices already on the market, in what’s known as the 510(k) process. For those devices, the device maker doesn't have to get approval from the FDA to sell it--they just have to give the FDA notification before they sell it. That means minor modifications to existing devices don’t require new clinical trials. When used intelligently, the rule is entirely appropriate--there's no need to redo clinical trials for small tweaks to products that can't affect the safety or effectiveness of the device. As the FDA has applied it, though, the 510(k) rule has become a giant loophole, and the vast majority (over 90%) of newly approved devices are approved through that pathway.

The problem is simple if you think of medical devices as undergoing evolution: each new device is slightly different from its parent (known as the "predicate" device). Once it's on the market, the modified device can be used as a predicate for another modification. Over time, compounding small changes can get you a tool or implant that bears no resemblance to the original device that actually went through clinical trials. Worse, some of the original predicates are those devices the FDA grandfathered in, and may never have gone through clinical trials.

The holes in the approval process have caused real harm. Take the example of metal-on-metal artificial hips: DePuy ASR hips were approved based on substantial equivalence to another hip with a metal head and a ceramic or polyethylene socket joint, so they were never tested prior to market. It was only after thousands of people received the hip that it became clear that the metal-on-metal joint was scraping off bits of cobalt-chromium alloy into patients’ bodies—and worse, the hips were failing early and often. If clinical trials had been conducted, thousands of patients might have been saved the pain and hassle of a failed hip and an extra operation to fix it.

There’s a better way to do device approvals—a middle ground between requiring randomized trials for every minute change in a device’s design and letting device manufacturers run completely free. We should be tracking what happens to patients after they receive new or experimental devices. We should develop a national, automated database that registers each patient who receives a recently-approved device, and monitor those patients for device-related complications for several years. During that time, all patients receiving the new device should be informed that their device is still semi-experimental, and that they are part of a Phase IV clinical trial to find out more about what the device actually does. If that information makes patients want to use older, better-understood devices, that's not a reason to claim regulations are holding back progress in medicine--it's giving patients complete information, and letting them choose the care they want. Forcing patients to use new, unproven devices (by failing to tell them about the experimental status) is no more ethical than denying patients new treatments in favor of old.

Tracking outcomes in a large-scale database works: a similar registry was a key part of the Australian research that discovered problems with DePuy hips. Reporting doesn't don’t have to be intrusive or an administrative burden, either. Wal-Mart and Amazon collect data on every transaction, every day, to better understand their customers and manage their inventory; customers hardly even notice. Even the data analysis can be largely automatic.

Tracking new, untested devices is a no-brainer. There are legitimate privacy concerns with such a database, but large datasets with  medical, personal, and financial information are routinely scrubbed so researchers can’t find private information about any individual. There’s no excuse for continuing to let Wal-Mart do better at understanding what affects its sales than researchers and doctors do at understanding how to make patients healthy.

The Number of the Day

June 12, 2012

The number of the day:  11%

That's right, kiddos.  The number of the day is 11%--the probability of randomly picking Grumpy if Snow White, the Seven Dwarves, and Prince Charming all sit down for tea... or, in this case, the 11% of people in the US, according to the CDC, who are taking five or more prescribed medicines. 

You read that right.  One in nine Americans is taking five or more prescription drugs.  In the medical world we call that "polypharmacy," and it makes the doctor's job a lot harder. Each new medicine that is introduced into your body increases the chance of drug-drug interactions with undesirable side effects. While practitioners receive extensive training on how these drugs interact and which ones not to combine, there still remains a risk associated with polypharmacy. The more possible interactions, the more likely it is that a doctor might miss one. That becomes even more likely when the evidence on drug interactions can be flawed, incomplete, or falsified. Having so many people on so many drugs is practically begging for errors to happen.

Such a suggestion is made by Jeanne Lenzer in a recent article published in the BMJ.  Lenzer cited a report from the Institute for Safe Medication Practices (ISMP) which "calculated that in 2011 prescription drugs were associated with two to four million people in the US experiencing serious, disabling, or fatal injuries, and 128,000 deaths."

Leading this pack of oft-misused drugs are anticoagulants like warfarin, which the authors report "prevents ischemic strokes in approximately 1% of high risk patients a year, but causes major bleeding in an estimated 3%."  Other harm-causing drugs include an antibiotic (levofloxacin); a cancer drug (carboplatin) and a hypertension drug (lisinopril).

Numbers like 11% suggest that we need to re-evaluate the safety and effectiveness of many "standard" practices.  Numbers like 11% contribute to the staggering 128,000 deaths associated with prescription drugs--that's 10 times the number of people killed in drunk driving accidents each year.  It's not surprising, then, that ISMP calls prescribed medicines "one of the most significant perils to human health resulting from human activity."  We have Mothers Against Drunk Driving, but maybe it's time for Mothers Against Profligate Prescription.

Big Win for Public Health - F.D.A. Style

April 17, 2012
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In case you missed it, the FDA came out with new rules last week to limit the use of antibiotics in farm animals. While at first glance this might seem unrelated to health issues in humans, it actually matters quite a lot. The connection works like this: the indiscriminate use of antibiotics to produce the food we eat contributes to the creation of antibiotic-resistant disease strains. When humans then get infected with these strains, antibiotics are ineffective at treating the new strains, thus posing a fairly significant public health risk.

This risk is not insubstantial. According to the New York Times, “at least two million people are sickened and an estimated 99,000 die every year from hospital-acquired infections, the majority of which result from such resistant strains.” Further, the use of antibiotics for farm animals is not an isolated occurrence – as Ezra Klein pointed out in the Wonkbook newsletter this week, “70 percent of the antibiotics used in this country – 70 percent! – go into livestock production.” The director general of the WHO, Margaret Chan, has warned that the overuse of antibiotics could “end medicine as we know it.”

So the overuse of antibiotics is bad for humans, bad for public health, and leads to up to $40 billion of avoidable care costs per year. It should be pointed out that many doubt the efficacy of the new rules, but even with these concerns, it’s a welcome first step towards reducing improper antibiotic use in farm animals and reducing avoidable care costs for those humans among us.

Some would argue that $40 billion might not seem much compared to the overall costs of health care, estimated at $2.6 trillion dollars in 2010 alone. That's barely over one percent of medical spending--but one percent matters! (It meets Zeke Emanuel's threshhold, at least.) The fact is, the medical spending problem is enormous, and we need small, common-sense changes in addition to large-scale payment and delivery-system reform if we want to make a difference.

Combating "Pharmapayola"

January 31, 2012
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Shannon Brownlee has a new piece up over at TIME Ideas. This time, it's a preview of the whole mess of information patients will soon be able to get about their doctors' financial relationships. It doesn't look pretty.

"As of this year, doctors who accept gifts and payments from drug and device makers will see their names on the web, the result of the 2010 Physician Payment Sunshine Act, one of the most controversial provisions in the health care reform law. Companies will be required to report any gift or payment to a doctor or academic researcher over $10, whether it’s in the form of stock options, speaking fees, box seat tickets, knickknacks for the doctor’s office or travel to a medical conference. Doctors will also be required to disclose payments and gifts."

While those payments don't necessarily meet the classic definition of payola (they are not a literal quid pro quo), the evidence showing its effect on prescribing habits is clear: Docs who take money from Pharma use their funders' products more often. Given the already-rampant misuse and ineffective use of prescription drugs and medical devices, that's ample reason to be concerned. When the data come out, check your doctor: you may be surprised.

The Latest Big Pharma Scandal

  • By
  • Shannon Brownlee,
  • New America Foundation
January 31, 2012 |

Imagine yourself in front of your computer, looking up information about a drug prescribed by your doctor. Your Internet search tells you that there is a cheaper, maybe even a generic version available, but you have just paid top dollar for the brand name drug. You also learn that another treatment may be safer than the prescription you just filled. Now imagine you discover that your doctor gets paid by the manufacturer to promote the drug to other doctors.

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