Get an Unsafe, Ineffective Medical Implant & Lose Your Civil Rights!

DeLauro Pushes to Protect Consumers from Unsafe Medical Devices

September 26, 2017 Press Release

WASHINGTON, DC (September 26, 2017) —Congresswoman Rosa DeLauro (CT-03) released the following statement urging Congress to pass the Medical Device Safety Act, which would enhance legal protection for victims of unsafe medical devices. Currently, high risk device manufacturers are protected from being held liable at the state and local levels if their device has received premarket approval from the Food and Drug Administration (FDA).

”One of our government’s most important duties is to keep our people safe from harm, whether it is the food we eat, the medications we take, or the medical devices we use,” said DeLauro. “Too often, that basic mission is going unfulfilled at the FDA. Failure at the FDA has awful consequences, as faulty medical devices have tragically injured, or even killed, thousands of Americans across the country.

“Instead of serving as a steward for public safety, the FDA has put its stamp of approval on these potentially unsafe devices, with manufacturers’ bearing no legal risk when things go wrong,” continued DeLauro. “Even after the FDA knows that these devices put people at risk, it simply will not take them off the market. That is why Congress must immediately pass the Medical Device Safety Act, to arm American families with the necessary tools to hold these companies accountable once and for all. I will not let up in the fight—alongside my colleagues and consumer advocates—to get this life-saving legislation signed into law.”

“The health of thousands of women has been negatively affected by FDA’s lack of proper oversight, specifically with Essure,” said Amanda Rusmisell, Legislative Liaison for the Essure Problems Group. “This product not only impacts women’s quality of life, it also puts an enormous financial strain on them and their families. Despite FDA’s Black Box Warning on Essure and our pleas to take this product off the market, women are still in the dark about its potential dangers— such as hysterectomies, autoimmune diseases, additional surgeries, and life-threatening health effects. That is why the Medical Device Safety Act is so crucial. Women deserve to know about the dangers of this product, and if they are impacted by Essure, they must be able to take action.”

DeLauro is a senior member on the subcommittee responsible for funding the U.S. Food and Drug Administration.

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Bayer Essure Failure Rate 10%: E-Free Act

Fitzpatrick’s E-Free Act Would Take Essure Off the Market

By Jay W. Belle Isle - Oct 27, 2015

U.S. Representative Mike Fitzpatrick (R-PA) is set to introduce a bipartisan bill to Congress regarding the dangerous Bayer HealthCare product Essure. This purportedly “permanent” birth control device not only doesn’t work, but has caused countless women incredible suffering. Fitzpatrick’s E-Free Act would take Essure off the market.

Essure is a flexible, nickel-titanium coil that is surgically implanted into the fallopian tubes. The resulting scar tissue is supposed to render the user sterile. However, studies have shown that the failure rate (i.e., number of women who’ve become pregnant) is almost 10%. Furthermore, the coil often migrates causing perforation damage and the nickel is causing multiple serious allergic reactions.

Fitzpatrick chose the November 4 introduction for the E-Free Act as that is the 13th anniversary of Essure getting premarket approval from the FDA, despite the review panel’s misgivings. The FDA held a committee hearing on September 24 to review Essure’s safety and efficacy, but no recommendations have yet been made to the agency.

Fitzpatrick issued a statement saying, “Bayer is a trusted name in the industry. However, right now, one of their products, the Essure device, is harming women and needs to be removed from the market. I believe it is imperative to the continued success of their brand and the other work they do to immediately end production of a product that poses such a danger to patient safety.”

One of the Congressman’s spokespeople said that his office has heard from hundreds of women complaining about Essure. Bayer’s spokeswoman, Tara DiFlumeri, countered that by stating that more than 10 years of research support Essure’s safety.

“Bayer stands by the positive benefit-risk profile of Essure and we look forward to working closely with the FDA as it considers the advice of its Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee,” she said. Bayer’s highest priority is patient safety and we sympathize greatly with any woman who may have experienced problems following an Essure procedure.”

Sure, there’s more than 10 years of Essure research out there. Internal documents have shown that Bayer “adjusted” some of that research, skewing it such that the FDA would grant premarket approval.

Bayer is no more sympathetic to the women victimized by its irresponsibility than is the FDA, which, despite its claims, turns a blind eye toward the suffering. Victims of Essure were not allowed to speak at the September 24 hearing; only medical professionals and industry representatives were heard.

The FDA may try to get away with silencing Essure victims, but Congress will hear these brave women this week. Below is a press release from Essure Problems, an advocacy group comprised of women injured by Essure:

“Four administrators of the Essure Problems Facebook page, Angie Firmalino, Amanda Dykeman, Lisa Saenz, and Melanie Goshgarian, their congressional liaison and E-Sister Amanda Rusmisell, E-Sister and scientist Tess Shulman, attorneys Marcus Susen and Holly Ennis, and local DC E-Sister Lisa Fouser, will be attending multiple congressional meetings tomorrow and Wednesday. The goal of their meetings is to gain support for Congressman Fitzpatrick’s E-Free Act. Congresswoman Rosa DeLauro has co signed the E-Free Act, and they will be presenting it to congress on November 4th, 2015, on the 13 year anniversary of the approval of Essure. The act asks that the FDA revoke PMA status for Essure and also remove it from the market. The meetings are listed below.

They will also be handing out packets to every single congressman and woman’s office. The packet can be viewed by clicking here.”

Joleen Chambers · Illinois Institute of Technology

The medical device industry has insinuated itself into our local, state and national government by lobbying for legislation that would protect it from accountability for unsafe and ineffective products. In addition, the FDA that is charged with protecting patients by regulating the industry is deeply financially conflicted with both Director Shuren (his wife Allison is a partner in a DC lawfirm specializing in medical devices and FDA clearance) and the members of advisory panels that are salaried by the medical industrial complex. There is no process for harmed patients to be heard.

FDA Scientists Gone Wild: Fraud in Advisory Panels and Clinical Trials?

Are Your Medications Safe?

The FDA buries evidence of fraud in medical trials. My students and I dug it up.

By Charles Seife  February 9, 2015

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

Much of my research has to do with follies, foibles, and fraud in science, and I knew that the FDA wasn’t exactly bending over backward to correct the scientific record when its inspectors found problems during clinical trials. So as part of my investigative reporting class at New York University, my students and I set out to find out just how bad the problem was—and how much important information the FDA was keeping under wraps.

The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct.

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and effective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site in Mexico, there was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out. The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be “unreliable.” Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.

It’s not just one study, either. The FDA found major problems with sites involved in the other three clinical trials that were used to demonstrate rivaroxaban’s safety and effectiveness. RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

The FDA’s failure to notify the public is not merely a sin of omission. In March 2009, the FDA convened a committee of outside scientific experts to mull the “robustness and meaningfulness” of the results from the four rivaroxaban trials, RECORDs 1, 2, 3, and 4. (The agency regularly calls in advisers to get advice, or, more cynically, to get cover, about a decision the agency has to make.) When the agency briefed the committee, it was (to put it mildly) coy about the problems it was finding. It said only that inspectors had found “significant issues” at two clinical sites involved in the RECORD 4 study—and that data from one of them was included in the analysis. Inspections were still ongoing, so it’s not easy to say precisely what the agency knew at that point, but it’s clear that the FDA wasn’t admitting to everything it knew. A bunch of inspections had been completed a month prior to the meeting, and we know for certain that the agency was fully aware of major issues beyond the two it revealed to the advisory committee. In a memo dated three days before the advisory committee meeting convened, the FDA detailed “falsification of data by a subinvestigator” at a RECORD 2 site. The advisory committee was not told.

By itself, this might seem like a miscommunication or an oversight, but the FDA has a history of not notifying the public about the misconduct it finds. About a decade ago, the agency got into trouble over a newly approved antibiotic, Ketek. Inspectors had found extensive problems (including fraud) affecting key clinical trials of the drug. Yet the agency did its best to hide the problems from even its most trusted advisers. As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.” However, when the reports of misconduct at one clinical site began appearing in the press—along with stories of liver damage and blurred vision associated with the new drug—Congress stepped in, demanding information from the agency about the fraud.

But even the Senate couldn’t wring key information about the misconduct out of the FDA. “Every excuse under the sun has been used to create roadblocks,” complained an indignant Sen. Charles Grassley, “even in the face of congressional subpoenas requesting information and access to FDA employees.” The head of the FDA, Andrew von Eschenbach, attempted to explain to Congress why the agency didn’t tell its advisory committee about the problems in the Ketek study: “After considering the fact that the investigation results were preliminary ... FDA decided to hold the Advisory Committee meeting as planned ...” without notifying the committee of the potential problems. But Rep. Bart Stupak quickly pointed to an email, which, he argued, contradicted von Eschenbach's testimony. “So either you are not being forthright with us, when I believe you are, but whoever is doing your work is trying to  lead this committee down the wrong path.” And the correct path showed that site after site involved in study 3014, as well as other key Ketek studies, were tainted as well.

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death ... than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud. In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

And the FDA covers up drug-related misconduct in other, more subtle ways, too. For example, the agency publishes the canonical listing of generic drugs in the United States, known as the “Orange Book.” Prescription drugs in this book are often given what’s called a “therapeutic equivalence code.” This code is a two-letter designation that signals the quality of the scientific evidence that a generic is “bioequivalent” to the name-brand drug. The code “AB,” for example, tells pharmacists and physicians that there are solid scientific studies proving that bioequivalence. Another code, “BX,” signals that there isn’t sufficient data to prove the generic is bioequivalent to the name brand.

When the Cetero misconduct was uncovered, key bioequivalence studies for scores of generic drugs turned out to be worthless. By rights, some of those drugs should have had their designation downgraded from AB to BX. But even though the FDA updates the Orange Book monthly, there was no rash of drugs losing their AB rating in the months after the Cetero affair broke. In the year and a half after the Cetero fraud was first announced, I was able to identify a grand total of four generic drugs (in various dosages) that were downgraded to BX, none of which appeared to be linked to the Cetero problem. On the other hand, the one prescription generic drug that I knew for sure had been hit hard by the Cetero fraud—both key studies supporting its bioequivalence to the name brand were declared worthless—had no change in its designation. The FDA apparently allowed the drug to keep its AB badge for months without any valid data backing the drug’s bioequivalence. When asked, point blank, whether the agency had downgraded the bioequivalence code of any products due to the Cetero affair, officials promptly dodged the question. A written statement issued by the agency’s press office in response to my queries noted that the FDA requested additional data from the companies whose drugs were implicated in the Cetero affair and that “If the data were not provided within 6 months or the data provided did not support a finding of bioequivalence, FDA said it would consider changing the generic product’s therapeutic equivalence rating in the Orange Book from AB to BX.” Not a word about a single bioequivalence rating actually being changed.  

Why does the FDA stay silent about fraud and misconduct in scientific studies of medicine?

This, too, is a pattern of behavior rather than a one-off. In the past few weeks, another major Cetero-type case began to emerge—this time, having to do with GVK Biosciences, a firm in Hyderabad, India. The European Medicines Agency, the European equivalent of the FDA, examined more than 1,000 drugs in various dosages affected by GVK’s “data manipulations” and has suggested pulling 700 off the market. You can find the full list on the EMA website; to their credit, the Europeans are being relatively transparent as the crisis develops. Not so much on this side of the pond, alas. So far from the FDA, we’ve heard precious little, even though there are drugs on the U.S. market that rely entirely on GVK’s tests. In a written statement, the FDA admitted that there were some 40-odd drugs whose approval depended upon GVK-run studies. Which ones? The agency is keeping mum, as it did with Cetero and with other similar cases. However, the agency assures us that it inspected GVK's facility and found nothing to be concerned about; if the situation changes, “FDA will take swift and appropriate action to ensure that the drug products available to American consumers are safe and effective.”

Why does the FDA stay silent about fraud and misconduct in scientific studies of pharmaceuticals? Why would the agency allow claims that have been undermined by fraud to appear on drug labels? And why on earth would it throw up roadblocks to prevent the public, the medical community, its advisory panels, and even Congress from finding out about the extent of medical misconduct? The answers the FDA gives are fascinating—they show how an agency full of well-meaning people can do intellectual backflips to try to justify secrecy.

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

Another excuse I’ve heard from the FDA is that it doesn’t want to confuse the public by telling us about problems, especially when, in the FDA’s judgment, the misconduct doesn’t pose an immediate risk to public health. For example, when my colleague and I asked the director of FDA’s Center for Drug Evaluation and Research why the agency wouldn’t name the drugs affected by the Cetero fraud, she told us that the matter “did not rise to the level where the public should be notified. We felt it would result in misunderstanding and inappropriate actions.” But even the most paternalistic philosophy of public health can’t explain why the FDA would allow drug companies to put data on its labels that the agency knows are worthless, or to fail to flag bioequivalence problems in a publication that is specifically designed for the purpose of flagging those very problems.

Charles Seife is a journalism professor at New York University. His most recent books are Sun in a Bottle: The Strange History of Fusion and the Science of Wishful Thinking and Proofiness: The Dark Arts of Mathematical Deception

http://www.slate.com/articles/health_and_science/science/2015/02/fda_inspections_fraud_fabrication_and_scientific_misconduct_are_hidden_from.single.html

FDA, Medical Device Industry Profit and Harmed Women Collide With Pope Francis in DC on September 24

Essure complaints spike nearly 1,400% in 3 years

SEPTEMBER 22, 2015 BY BRAD PERRIELLO 

The FDA logged a nearly 1,400% spike in complaints filed over the Essure permanent female sterilization treatment made by Bayer (ETR:BAYN), according to a review released yesterday ahead of an FDA advisory panel meeting this week.

Essure, the only approved permanent birth control device in the U.S., is a small metal coil that is placed in the fallopian tubes via catheter. The FDA approved the device in November 2002.

In the near 13 years since then, the health regulator said it had received 5,093 complaints, including those of pain or menstrual irregularities after using the device, as well as complaints of the device breaking. Those adverse event reports include 5 fetal deaths in women who became pregnant after using Essure and 4 adult deaths for reasons such as infection and uterine perforation, the FDA said.

There were 152 complaints filed in the FDA’s Manufacturer & User Facility Device Experience database in 2012; last year there were 2,259 complaints filed in the MAUDE database, a 1,386% increase. So far this year there have been 1,363 MAUDE complaints filed with the FDA, the agency said. The FDA cautioned that the complaints it received had limitations such as incomplete or inaccurate data and did not necessarily directly indicate a faulty or defective device.

The FDA’s Obstetrics and Gynecology Devices advisory panel is set to meet Sept. 24 to discuss the risks and benefits of Essure and has invited feedback from presenters, panel members and the public. Some 17,000 women who had the device implanted and claim it has hurt them are members of the Facebook group “Essure Problems,” run by Angela Lynch, who herself experienced problems with Essure. Complaints voiced by the women include chronic pain, heavy bleeding, fatigue and skin allergies.

Lynch, who was 28 when she was implanted with the device, had 3 children and did not want any more.

“Because I had just had a kid I wrote off all my symptoms as hormonal, my body trying to adjust,” she said. “After 2 years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.”

In 2012 she had the device removed and underwent a hysterectomy.

“After 3 days it was like I woke up from a 5-year flu,” she said.

In May, Bayer cited a 364-patient 5-year study of the device published in the Journal of Minimally Invasive Gynecology that indicated no pregnancies after 5 years and that the Essure inserts were “generally well tolerated.” Pelvic pain was reported in no more than 7% of patients, but no study participants reported persistent pelvic pain of any kind at the 3-, 4-, and 5-year follow-up visits, according to Bayer.

The study reported 3 serious adverse events “possibly related” to Essure in the trial, including irregular menstrual bleeding, lower abdominal pain and heavy periods and continuous bleeding. The latter 2 patients ended up having hysterectomies.

Dr. Patricia Carney, the company’s medical director for Essure, said Bayer welcomes the discussion. “We want to understand as a company what is going on,” she said. “We want to know whether there is a link to the product.”

In February a citizens petition lodged with the FDA asked the safety regulator to take Essure off the U.S. market, alleging that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.

In July, the FDA approved using transvaginal ultrasound as an alternate test to confirm if the Essure implant has been placed properly. A month later Bayer cut the ribbon on a new plant in Costa Rica where it plans to make Essure.

Material from Reuters was used in this report.

http://www.massdevice.com/essure-complaints-spike-nearly-1400-in-3-years/

The FDA's Medical Device Problem

The F.D.A.’s Medical Device Problem

By RITA F. REDBERG and SANKET S. DHRUVA              JULY 17, 2015

THE Food and Drug Administration has been regulating the approval of medical devices since 1976, but its regulatory oversight has not kept pace with the increasing complexity of this technology. Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials). And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).

As a result, there have been many warnings about, and recalls and withdrawals of, medical devices that were found to be dangerous only after they were on the market. (In 2009, for example, the Sprint Fidelis defibrillator, which by that time had been implanted in hundreds of thousands of heart patients, was recalled because it frequently malfunctioned, harming many patients and leading to numerous deaths.) And because the F.D.A.’s oversight of medical devices once they are on the market is also weak, it is very likely that many malfunctions and other problems remain undetected.

Incredibly, legislation that the House of Representatives passed last week would severely weaken, not strengthen, the F.D.A.’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.

The legislation, disingenuously titled the 21st Century Cures Act, would make it possible for companies that produce high-risk medical devices to submit evidence of safety and efficacy based on sources other than clinical trials, including case histories (i.e., the experiences of individual patients). In other words, anecdotal evidence, rather than the scientific studies, could be used to approve devices.

This act would also create a new, faster approval process for “breakthrough technologies” that are believed — but not necessarily proved — to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk. The legislation defines “breakthrough” loosely, creating a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.

In general, the proposed law is likely to shift the burden of evidence to clinical studies that are conducted only after the devices have been put on the market. Unfortunately, such studies are often delayed months to years after a device is approved. Many are never completed (and even when they are, their findings are often not publicly available). Although the proposed law alludes to “timely postmarket data collection,” that vague directive needs to be clearly defined — and more important, enforced — by the F.D.A. In fact, according to a 2014 journal article co-written by one of us, the F.D.A. has never issued a warning letter or penalty for a postmarket study delay.

Even if a postmarket clinical study deems a medical device dangerous, it still can be difficult to remove it from the marketplace. In 2005, for example, an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence, the F.D.A. did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.

Once a medical device is developed and approved, its manufacturer often makes small changes intended as enhancements (such as using a different size wire or new material). Currently, the F.D.A. is the arbiter responsible for ensuring that these changes result in a safe and effective device. But alarmingly, the 21st Century Cures Act would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.

The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health.

Rita F. Redberg is a cardiologist at the University of California, San Francisco, Medical Center. Sanket S. Dhruva, a cardiologist, is a clinical scholar at Yale University.

http://www.nytimes.com/2015/07/17/opinion/the-fdas-medical-device-problem.html?emc=edit_tnt_20150717&nlid=50639700&tntemail0=y&_r=0

Medical device warranty: an antidote to industry entitlements? Congress is selling out!

The 21st Century Cures Act — Will It Take Us Back in Time?

Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

June 3, 2015   (FiDA highlight)

In May 2015, the 21st Century Cures Act was introduced in the U.S. House of Representatives, with the goal of promoting the development and speeding the approval of new drugs and devices.1 Championed by the pharmaceutical, biotechnology, and device industries, the bill was approved unanimously (51 to 0) in committee and continues to be debated. If enacted into law, some of its provisions could have a profound effect on what is known about the safety and efficacy of medical products, as well as which ones become available for use.

Some aspects of the bill could indeed enhance the development of and access to new drugs. The legislation calls for annual increases in the stagnating budget for the National Institutes of Health (NIH) amounting to about 3% per year for 3 years when adjusted for inflation. It would also provide an additional $2 billion per year for 5 years to create an “NIH Innovation Fund.” Together, this support would help counteract the effects of sequestration and budget cuts that have reduced the purchasing power of the NIH to its lowest level in years. Given the crucial role that NIH-funded research plays in generating the findings on which so many new drugs are based,2 this boost would be a welcome development. Another useful provision could make deidentified data from NIH-funded clinical trials more available to researchers.

Other proposed changes could lead to less salutary outcomes for patients and the health care system. An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two thirds of new drugs are approved on the basis of studies lasting 6 months or less3 — a potential problem for medications designed to be taken for a lifetime. Once the Food and Drug Administration (FDA) starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments.

Nonetheless, as introduced, the 21st Century Cures Act instructs the FDA to consider nontraditional study designs and methods of data analysis to further speed approvals. Adaptive trial designs and the use of Bayesian methods hold promise in some kinds of evaluations, particularly in oncology. However, more problematic proposals include encouraging the use of “shorter or smaller clinical trials” for devices and the request that the FDA develop criteria for relying on “evidence from clinical experience,” including “observational studies, registries, and therapeutic use” instead of randomized, controlled trials for approving new uses for existing drugs. Although such data can provide important information about drug utilization and safety once a medication is in use, there is considerable evidence that these approaches are not as rigorous or valid as randomized trials in assessing efficacy.

The bill would also encourage the FDA to rely more on biomarkers and other surrogate measures rather than actual clinical end points in assessing the efficacy of both drugs and devices. The FDA already uses surrogate end points in about half of new drug approvals.3 Some biomarkers are accurate predictors of disease risk and can be useful measures of the efficacy of a new drug (such as low-density lipoprotein cholesterol for statins). But though a drug's effect on a biomarker can make approval quicker and less costly, especially if the comparator is placebo, it may not always predict the drug's capacity to improve patient outcomes. Bevacizumab (Avastin) delayed tumor progression in advanced breast cancer but was shown not to benefit patients. Similarly, rosiglitazone (Avandia) lowered glycated hemoglobin levels in patients with diabetes even as it increased their risk of myocardial infarction. In 2013, patients began to receive a new drug for tuberculosis approved on the basis of a randomized trial relying on a surrogate measure of bacterial counts in the sputum — even though patients given the drug in that trial had a death rate four times that in the comparison group, mostly from tuberculosis.4 These provisions in the legislation would not immediately change FDA approval standards, but they would give the agency greater discretion, backed by congressional support, to approve drugs on the basis of less rigorous data.

The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a “serious or life-threatening infection” in patients with an “unmet medical need.” In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as “preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.” Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

The 21st Century Cures Act goes still further in altering the requirements for approving medical devices — an area long criticized for lack of rigor as compared with drug evaluations,5 though regulatory oversight has improved in recent years. As proposed, the new law would redefine the evidence on which high-risk devices can be approved to include case studies, registries, and articles in the medical literature, rather than more rigorous clinical trials. Another section would allow device makers to pay a third-party organization to determine whether the manufacturer can be relied on to assess the safety and effectiveness of changes it makes to its devices, in place of submitting an application to the FDA. Thus certified by the external company, a device maker would be authorized to continue to assess its own products on an ongoing basis.

Informed consent by patients in drug trials has traditionally been sacrosanct, with exceptions made only when consent is impossible to obtain or contrary to a patient's best interests. But another clause in the proposed law adds a new kind of exception: studies in which “the proposed clinical testing poses no more than minimal risk” — a major departure from current human subject protections. It is not clear who gets to determine whether a given trial of a new drug poses “minimal risk.”

Embedded in the language of the 21st Century Cures Act are some good ideas that could streamline the development and evaluation of new drugs and devices; its call for increased NIH funding may prove to be its most useful component. But political forces have also introduced other provisions that could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.

Over the past 80 years, this country's regulatory approach has embraced steadily improving criteria for accurately assessing therapeutic efficacy and risk. Patients and physicians would not benefit from legislation that instead of catapulting us into the future, could actually bring back some of the problems we thought we had left behind in the 20th century.

http://www.nejm.org/doi/full/10.1056/NEJMp1506964?query=TOC&

Healthcare lobbyists outnumber Congress 5 to 1. Are the voters revolted yet?

Polluted Political Games

MAY 28, 2015  Nicholas Kristof                                                                                                                                       I’ve admired the Clintons’ foundation for years for its fine work on AIDS and global poverty, and I’ve moderated many panels at the annual Clinton Global Initiative. Yet with each revelation of failed disclosures or the appearance of a conflict of interest from speaking fees of $500,000 for the former president, I have wondered: What were they thinking?

But the problem is not precisely the Clintons. It’s our entire disgraceful money-based political system. Look around:

• Gov. Chris Christie of New Jersey accepted flights and playoff tickets from the Dallas Cowboys owner, Jerry Jones, who has business interests Christie can affect.

• Senator Marco Rubio of Florida has received financial assistance from a billionaire, Norman Braman, and has channeled public money to Braman’s causes.

When problems are this widespread, the problem is not crooked individuals but perverse incentives from a rotten structure.

“There is a systemic corruption here,” says Sheila Krumholz of the Center for Responsive Politics, which tracks campaign money. “It’s kind of baked in.”

Most politicians are good people. Then they discover that money is the only fuel that makes the system work and sometimes step into the bog themselves.

Money isn’t a new problem, of course. John F. Kennedy was accused of using his father’s wealth to buy elections. In response, he joked that he had received the following telegram from his dad: “Don’t buy another vote. I won’t pay for a landslide!”

Yet Robert Reich, Bill Clinton’s labor secretary and now chairman of the national governing board of Common Cause, a nonpartisan watchdog group, notes that inequality has hugely exacerbated the problem. Billionaires adopt presidential candidates as if they were prize racehorses. Yet for them, it’s only a hobby expense.

For example, Sheldon and Miriam Adelson donated $92 million to super PACs in the 2012 election cycle; as a share of their net worth, that was equivalent to $300 from the median American family. So a multibillionaire can influence a national election for the same sacrifice an average family bears in, say, a weekend driving getaway.

Money doesn’t always succeed, of course, and billionaires often end up wasting money on campaigns. According to The San Jose Mercury News, Meg Whitman spent $43 per vote in her failed campaign for governor of California in 2010, mostly from her own pocket. But Michael Bloomberg won his 2009 re-election campaign for mayor of New York City after, according to the New York Daily News, spending $185 of his own money per vote.

The real bargain is lobbying — and that’s why corporations spend 13 times as much lobbying as they do contributing to campaigns, by the calculations of Lee Drutman, author of a recent book on lobbying.

The health care industry hires about five times as many lobbyists as there are members of Congress. That’s a shrewd investment. Drug company lobbyists have prevented Medicare from getting bulk discounts, amounting to perhaps $50 billion a year in extra profits for the sector.

Likewise, lobbying has carved out the egregious carried interest tax loophole, allowing many financiers to pay vastly reduced tax rates. In that respect, money in politics both reflects inequality and amplifies it.

• Lobbyists exert influence because they bring a potent combination of expertise and money to the game. They gain access, offer a well-informed take on obscure issues — and, for a member of Congress, you think twice before biting the hand that feeds you.

The Supreme Court is partly to blame for the present money game, for its misguided rulings that struck down limits in campaign spending by corporations and unions and the overall political donation cap for individuals.

Still, President Obama could take one step that would help: an executive order requiring federal contractors to disclose all political contributions.

COMMENTS

“President Obama could bring the dark money into the sunlight in time for the 2016 election,” notes Michael Waldman of the Brennan Center for Justice at the New York University School of Law. “It’s the single most tangible thing anyone could do to expose the dark money that is now polluting politics.”

I’ve covered corrupt regimes all over the world, and I find it ineffably sad to come home and behold institutionalized sleaze in the United States.

Reich told me that for meaningful change to arrive, “voters need to reach a point of revulsion.” Hey, folks, that time has come.☐

http://www.nytimes.com/2015/05/28/opinion/nicholas-kristof-polluted-political-games.html

Write to cures@mail.house.gov by June 13, 2014. Here's why!

21st Century Cures – Patients 

“There are 7,000 known diseases. We have treatments for only 500 of them. We have work to do.”1 

For patients and their families, the gap between the number of diseases and the number of treatments is not a statistic; it is their daily struggle. Despite the medical breakthroughs of recent years, for many diseases, treatments or research simply do not exist. 

Through legislation such as the Food and Drug Administration Safety and Innovation Act and the PREEMIE Reauthorization Act, which included the National Pediatric Research Network Act, the Energy and Commerce Committee has sought bipartisan solutions to facilitate and accelerate patient access to innovative treatments. Although progress has been made, significant work remains. That is why we launched the 21st Century Cures initiative, and the involvement and guidance of those patients on the frontlines and their advocates is critical. Our goal of accelerating the cycle of discovery, development, and delivery of promising new treatments and cures is shared by many, but perhaps most of all by patients and their families. 

The committee appreciates that certain aspects of the discovery, development, and delivery cycle have different meanings for different patients. Depending on the condition or disease at issue, the state of biomedical research, and the translation of such research into treatments and cures, varies. We want to hear about the state of biomedical research and therapeutic innovation for specific diseases and better understand how Congress can help move the ball forward. 

To help the committee’s effort, we are seeking input from the patient community on the following questions: 

􏰀 What is the state of discovery of cures and treatments for your disease? Are there cures and treatments now or on the horizon? 

1 Statement of Margaret Anderson, Executive Director of FasterCures, at the 21st Century Cures Roundtable held on May 6, 2014, http://www.youtube.com/watch?v=Fr4Re7sfDzE&t=33m21s. 

• 􏰀  What programs or policies have you utilized to support and foster research, such as patient registries, public-private partnerships, and venture philanthropy?
  
• 􏰀  How can Congress incentivize, coordinate, and accelerate basic research for diseases we know relatively little about?
  
• 􏰀  How can we work together to better translate advances in science into safe and effective new therapies for patients?
  
• 􏰀  How do you coordinate your research and outreach with other patients?
  
• 􏰀  How do you learn about new treatments and cures? How do you communicate with other
  patients regarding treatments and cures?
  
• 􏰀  What can we learn from your experiences with clinical trials and the drug development process?
  
• 􏰀  What is the role of government in your work, including any barriers to achieving your goals and advancing breakthroughs?
  
• 􏰀  How should regulators evaluate benefit-risk? How do you work with regulators regarding benefit-risk? Can this process be improved?
  
• 􏰀  What is the role of public and private funding in the research and development of cures and treatments?
  
• 􏰀  Are there success stories the committee can highlight and best practices we can leverage in other areas?
  
• 􏰀  How have you worked with other patients to support one another?
  
• 􏰀  What is the financial burden of your disease? How would better treatments and cures help
  save money for your family and the federal government?
  
• 􏰀  How can Congress help?
  Public input is critical to the 21st Century Cures initiative, especially from the patient community. With the staggering gap between the number of diseases and available treatments, there are undoubtedly countless untold stories that will provide guidance and perspective in this effort. We request all submissions and suggestions be sent to cures@mail.house.gov by June 13, 2014. 

http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140516PatientsWhitePaper.pdf

Take Action Now! Tell Congress NO on 21st Century Cures bill.

Congress is working on a bill called 21^st Century Cures that would lower the standards for approving drugs and medical devices.  They say it will benefit patients, but it was written primarily by industry.  Unfortunately, a key vote will be tomorrow  morning 5/19/2015!

The National Center for Health Research has drafted a letter to the House of Representatives for individuals to sign with their name and city/state/zip code.  Please spread the word to friends and relatives that care about safe medical products!   

I can’t emphasize enough how important it is that Congress hear from as many individuals as possible NOW!

Diana Zuckerman, Ph.D.
President

National Center for Health Research

Cancer Prevention and Treatment Fund

1001 Connecticut Ave, NW, Ste. 1100

Washington, DC 20036

(202) 223-4000

www.center4research.org

www.stopcancerfund.org

NCHR Twitter / NCHR Facebook

CONSUMER VERSION

Dear Representative XXX,

As patients and consumers from across the country, we are writing to share our very strong opposition to several sections of the 21^st Century Cures legislation.  A few of the issues of particular concern to us follow.  We are not lobbyists, we are American taxpayers, and we hope you will improve the bill to better reflect the needs of regular people like us. 

Subtitle D: Modern Clinical Design, Section 2062 and 2063

FDA standards have developed over the last 100 years so that Americans could trust that medical products are proven safe and effective in scientific studies on humans.  Randomized clinical trials are the gold standard to make sure that a new drug, device, or vaccine is safe and effective.  This section encourages the FDA to lower its standards to even include anecdotes that the bill calls “clinical experience.”  Please remember that clinical experience resulted in tragedies such as thalidomide and the Dalkon shield.  

Whether the FDA is reviewing a drug for a new use, for long-term studies after a drug is already approved, or for a new drug, the FDA should compare the drug to make sure its benefits are greater than its risks for most patients.  That means it needs to be studied on hundreds of men and women, of different ages and different races.  

In medicine, physicians are looking for “evidence-based medicine” not the opinions of a few doctors.  That’s why this section is so dangerous for patients: it would allow the use of individual experiences or summaries of studies (instead of the details of the studies)

 Sections 2121: Approval of Drugs for a Limited Population of Patients

We all worry about antibiotic resistance, but this section tries and fails to address it.  It discourages the FDA from relying on randomized clinical trials that evaluate the impact of a drug on real patients, and instead encourages the FDA to rely on preliminary data.  That might be justifies for patients who would otherwise die without an experimental drug, but unfortunately there is no way for the FDA to prevent these drugs from being promoted and prescribed for all patients.  Millions of patients could die as a result.

4.      Section 2123: Encouraging the Development and Use of New Antimicrobial drugs

This section would pay a bonus to hospitals to prescribe new antibiotics and anti-fungals.  But, these drugs should be used only when needed, to preserve their effectiveness as long as possible.  Many frail elderly patients are put on antibiotics whenever they get sick, in order to prevent pneumonia.  If Congress encourages hospitals to prescribe these new drugs, it encourages overuse and inappropriate use.  The result: fewer effective antibiotics and a Medicare system that goes broke even sooner than many have predicted.

5. Subtitle L, M, and N:  Medical Devices:  

FDA standards for medical devices are lower than for drugs, resulting in patients harmed from artificial hips, unsafe stents, contact lens solution, surgical mesh, and many other common devices.  The device sections in this proposed legislation would lower the standards even more.  How does that make sense? 

Section 2221, Third-party Assessment:  When a company wants to make changes to a medical device that is already on the market, FDA scientists should decide if the changes will change the safety and effectiveness of that product.  Companies should not be allowed to choose to pay a 3^rd party to decide if FDA needs to review those changes.  That is just common sense.

Section 2222,  Medical Device Approvals: This section lowers the standards FDA uses to approve high-risk medical devices such as heart, brain, and spinal implants.  It would allow approval based on case studies, which include only one or two patients.  But the experience of a small number of patients is not necessarily typical of what will happen to most patients, especially patients of the opposite sex or different age.  It would also allow evidence from peer reviewed medical journals instead of evidence from the actual patient data.  Unfortunately, studies in medical journals can be inaccurate, incomplete, or biased.

Health Software: Electronic medical records and other health software help doctors make medical decisions about their patients.  That’s why it is important that the software works well and won’t crash when the patients’ lives are at stake.  FDA should evaluate these devices at least as carefully as they evaluate hip and knee implants, for example.

6.   Section 3041:  Reducing Transparency in the Sunshine Act for Physicians Payments

We are glad that Congress previously required companies to make public their payments to physicians.  That law helps patients know if their doctors have a financial relationship with a company that makes a drug or device that the physician is recommending.  So we are very disappointed that Congress has already proposed a loophole for fees or gifts to doctors that are intended for “continuing medical education” purposes at fancy resorts or other meetings. It also would exempt expensive gifts such as medical textbooks and journals. Although we want doctors to be up-to-date in their education, we believe doctors make enough money to buy these themselves.  

As patients and consumers from across the country, we ask you to pause before passing this bill.  You’re moving too fast on a law that will affect every single person in this country.  We deserve a better bill and a more careful review of the fine print that could save lives if done correctly, and cost many lives if it isn’t very carefully evaluated and revised.

Sincerely,