Dan Vergano, BuzzFeed: May 11, 2018

President Trump promised to lower drug costs through more generic drugs, improved Medicare rules, and less “foreign freeloading” on US companies’ research.

President Donald Trump unveiled his “American Patients First” proposal to lower drug prices on Friday, in a long-awaited speech on an issue he campaigned on.

“We will have tough negotiations, more competition, and much lower drug prices,” said Trump in the speech held at the White House Rose Garden. “Very soon.”

Prescription drugs cost the US some $329 billion in 2016, according to federal estimates. Price hikes — for EpiPens, cancer drugs, and an antiparasitic medication that jumped from $13.75 to $750 per pill — have raised the political profile of the issue.

The speech comes days after revelations that pharma behemoth Novartis paid Trump’s personal lawyer, Michael Cohen, some $1.2 million last year for access to the president and his administration.

During the presidential campaign, Trump said he would force the government to negotiate lower drug prices. During his presidential transition, he said drug companies were “getting away with murder,” comments that caused panic in the industry.

In his Friday speech, he criticized pharmaceutical industry lobbying, which outmuscles many other industries, and outlined his new “blueprint” for lower drug prices. But Trump stopped short of letting the US government agencies directly negotiate drug prices, including the $675 billion Medicare program. The president described such negotiation as “foreign freeloading” when done overseas, leaving the US with the world’s highest pharmaceutical prices.

Instead, Trump focused on four areas:

—increasing the transparency of drug prices seen in ads and by Medicare patients;

—preventing the manipulation of FDA, Medicaid, and the Affordable Care Act drug quality rules to force cheaper drugs out of patients’ hands;

—promoting lower-cost drugs for Medicare and Medicaid patients;

—and stopping foreign countries from negotiating lower drug prices with pharma, which the administration has argued forces US consumers to pay higher prices…

And some health analysts are critical of Trump’s approach.

“The action plan is too vague. Better negotiation of prices could mean almost anything,” Diana Zuckerman, president of the nonprofit National Center for Health Research, told BuzzFeed News. Focusing on out-of-pocket patient expenses instead of lower prices for the drugs themselves will lead to higher health insurance costs, she said. For example, when drugs cost more than $100,000 per year, as many do now, taxpayers and people buying insurance bear the cost, not just the patients taking the drugs…

Read the original article here.

Matthew Perrone, The Associated Press: April 17, 2018

U.S. health officials on Tuesday proposed steps to improve the government’s system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.

Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

“We want to have better tools for detecting issues that occur post-approval,” FDA Commissioner Scott Gottlieb said Tuesday. “But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening.”

An agency critic said the report contains few concrete changes and “many sections that will please the device industry.”

“FDA’s safety strategies for medical devices are still years away from effective implementation,” said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group. “Overall, the report indicates that the FDA’s approval standards for medical devices remain completely inadequate.” […]

Among other proposals laid out in the FDA’s “Medical Device Safety Action Plan,” the FDA will consider:

— How to quickly require additional safety requirements for certain devices, including training for doctors who work with the complex devices.

— Extra scrutiny of devices for women, following recent problems with vaginal mesh, the birth control implant Essure and surgical tools.

— New ways to encourage manufacturers to improve safety, including quicker approval for devices that appear safer than what’s available.

— Requiring cybersecurity features for electronic devices like implantable heart pacemakers and defibrillators.

The agency will also ask Congress for more money for a public-private system intended to monitor insurance claims, electronic health records and other data sources for early signs of device problems. The project is estimated to cost $250 million over five years to become operational; it is now slated to receive $30 million from device manufacturers.

Read the original article here.

Joyce Frieden, MedPage Today, April 10, 2018

New final regulations on the Affordable Care Act (ACA) health insurance exchanges issued by the Centers for Medicare & Medicaid Services (CMS) have drawn mixed reactions from health policy experts and others.

The rule makes a number of changes to the exchanges, including:

• Expanding the number of “benchmark” plans from which states can choose to model their coverage of the 10 “essential health benefit” (EHB) categories included in the ACA, potentially allowing states to choose plans with more generous or skimpier coverage than is currently offered on their exchanges.
• Adding several new “hardship exemptions” to allow consumers to avoid paying a penalty for not buying health insurance. One exemption is for consumers who live in an area in which there are no health plans offered for them on the exchange, or only a single plan offered which is unaffordable. Another exemption is for consumers who live in an area in which the only health plans offered provide coverage of abortions, in cases where that conflicts with the consumer’s personal beliefs.
• Allowing states to adjust the “medical loss ratio,” which determines what percentage of a health insurer’s revenue must be used for paying healthcare costs. Currently, according to the ACA, health insurers must spend at least 80% of their revenue on healthcare claims and quality improvement, with the rest going toward overhead and profit.
• Increasing the percentage premium increase which requires review by insurance regulators. Under current ACA rules, review is triggered if an insurer requests to increase rates by an average of 10% or more; the new regulations increase that threshold to 15%.

“The final rule will mitigate the harmful impacts of Obamacare and empower states to regulate their insurance market,” CMS said Monday in a press release on the regulations. “The rule will do this by advancing the Administration’s goals to increase state flexibility, improve affordability, strengthen program integrity, empower consumers, promote stability, and reduce unnecessary regulatory burdens imposed by the Patient Protection and Affordable Care Act.” The release also asserted that the ACA “has led to higher premiums and fewer choices” and that the ACA “has priced many consumers out of the insurance market.”

Premium Increases for Comprehensive Plans

“The plan to allow the sale of policies with skimpier essential health benefits will inevitably cause premiums for good health insurance policies (the kind currently available through the ACA) to increase,” Diana Zuckerman, PhD, president of the National Center for Health Research, an organization that conducts, analyzes, and explains health-related research, wrote in an email.

“If very healthy people can buy skimpy health insurance policies, then people who know that they have health problems will be the only ones buying the better policies — resulting in an increase in costs. In other words, people with pre-existing health conditions such as cancer, heart disease, diabetes, and rare diseases, will be paying much more than anyone else — an outcome that most Americans do not want. The bottom line is that the result of these regulations will be exactly the opposite of the stated goal: rather than making healthcare more affordable, this would make health care much less affordable for the people who need it most.” […]

Read the original article here.

Emily Kopp, Sydney Lupkin, and Elizabeth Lucas, Kaiser Health News: April 6, 2018

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies over 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania who co-authored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent — in varying degrees — about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups — with annual revenues as large as $3.6 million — relied on the pharmaceutical companies for at least 20 percent of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What Drives The Money Flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act — a law that required payments to physicians from makers of drugs and devices to be registered on a public website — but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015 the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as The National Women’s Health Network, based in Washington, D.C., make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.” […]

They Weren’t Always Backed By Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner — pharma or otherwise — decides our mission priorities,” including a scientific advisory board — free of sponsor influence — that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington — plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said. […]

Read the original article here.

Jim Spencer, Star Tribune: February 24, 2018

A Food and Drug Administration (FDA) proposal to let medical device makers summarize malfunctions of certain products instead of filing a report for each incident has kicked off a debate over the public’s ability to judge safety.

Regulators and device industry representatives say the proposal is an efficiency measure limited to malfunctions that do not threaten lives or health and only involves the least risky devices on the market. Summaries that bundle “like events” into summary reports as the FDA proposes let the government, businesses and the public pick up on trends sooner, they say.

“I think it will be very good and not just for our members,” said Shaye Mandle, CEO of Medical Alley, the trade group representing Minnesota’s massive medical technology sector. “I think everybody wins.”

Currently, device makers must file individual reports of device problems with detailed narratives. Depending on the severity of the malfunction, those reports are due within five days or 30 days of a company learning about them from any source.

The move to quarterly filings of single report summaries concerns some patient advocates and those seeking more detailed public disclosure of device problems. They base their worry on existing FDA summary reporting programs that they say keep too many details secret.

“FDA already has difficulty keeping up with device reports that would generate corrective action in a timely manner,” said Jack Mitchell, director of health policy at the National Center for Health Research. “When companies have submitted summary reports in the past, it has resulted in less transparency, with neither FDA nor the public able to have access to adequate information about patients who have been seriously harmed by medical devices. This proposal would further weaken the current post-market safety surveillance system for devices, which is already passive and inadequate.”

Star Tribune investigations into current FDA summary reporting practices found that the agency allowed Medtronic to summarize a study that revealed more than 1,000 malfunctions of its Infuse bone graft in three sentences within a single “marker report” more than five years after the law required the company to reveal those adverse events individually. The FDA also redacted the total number of injuries and complications as a “trade secret” until the newspaper appealed the decision.

Medtronic says that it should have filed the data sooner, but says it misplaced the study for several years and reported it as soon as it was found. The company says it then complied with all requests the FDA made for information about the study.

Medtronic declined to comment on the new FDA summary program, deferring to its national trade group, the Advanced Medical Technology Association (AdvaMed).

In addition to letting Medtronic summarize overdue malfunction reports, the Star Tribune investigation discovered that the FDA has allowed other companies to offer limited, consolidated and sometimes redacted data on thousands of late individual malfunction reports through an informal process called “retrospective summary reporting.”

An FDA spokeswoman did not respond to a question about redactions. She said she could not speculate on whether individual products such as Infuse would qualify for the new summary reporting program, which lets companies that make products with certain device codes file quarterly reports in a summary format. Nor would she say how or if malfunctions resulting from non-FDA-approved uses of devices would be cataloged. Off-label use can be an issue. For instance, research has estimated that Infuse is used off-label 85 percent of the time. […]

Read the original article here.

Mary Caffrey, The American Journal of Managed Care Newsroom: January 31, 2018

President Donald Trump returned to a popular campaign theme in Tuesday’s State of the Union address when he vowed to bring down the high cost of prescription drugs. But Trump’s only specific solution—calling on Congress to pass a right-to-try law—doesn’t address the broader problem affecting millions of Americans: the annual increases of necessary drugs for chronic conditions, such as insulin for diabetes or anti-inflammatory biologics for rheumatoid arthritis.

“There’s certainly been a gap between rhetoric and reality,” John Rother, president and CEO of the National Coalition on Health Care (NCHC), told The American Journal of Managed Care^®in an interview.

Previously, NCHC ran the Campaign for Sustainable Rx Pricing, which did extensive polling during the 2016 election cycle on Americans’ views on prescription drug pricing. Rother agreed with the overnight observation that the president highlighted the issue for a convenient reason: the president’s own poll numbers are not good, and polls still show Americans are frustrated with high drug prices. A poll taken last fall by the Harvard School of Public Health found that 40% of Americans want Congress to bring down prescription drug prices—a higher score than any other issue surveyed, according to POLITICO.

“One of my greatest priorities is to reduce the price of prescription drugs,” Trump said Tuesday night. “In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

He called on Congress to pass so-called right-to-try legislation, which allows patients to bypass FDA’s Expanded Access program and go straight to the pharmaceutical companies to purchase investigational medications if they are facing a terminal disease. Several states have passed their own versions of right-to-try laws. Diana Zuckerman, president of the National Center for Health Research and a board member of the Reagan-Udall Foundation, told attendees at Patient-Centered Oncology Care® in November 2017 that the Right-to-Try bill that has passed the Senate has far fewer requirements than the FDA’s Expanded Access program; and there are concerns that patients taking these drugs will not track adverse effects, which could threaten the current system of drug development. […]

Read the original article here.

Sydney Lupkin, Kaiser Health News: January 25, 2018

Alex Azar’s job hop from drugmaker Eli Lilly to the Trump administration reflects ever-deepening ties between the pharmaceutical industry and the federal government.

A Kaiser Health News analysis shows that hundreds of people have glided through the “revolving door” that connects the drug industry to Capitol Hill and to the Department of Health and Human Services.

Azar was confirmed Wednesday as  HHS secretary, joining other former drug industry alumni in top positions.

Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by Legistorm, a nonpartisan congressional research company. On the flip side, the analysis showed, more than a dozen former drug industry employees now have jobs on Capitol Hill — often on committees that handle health care policy.

“Who do they really work for?” said Jock Friedly, Legistorm’s president and founder, who called that quantity “substantial.” “Are they working for the person who is paying their bills at that moment or are they essentially working on behalf of the interests who have funded them in the past and may fund them in the future?”

In many cases, former congressional staffers who now work for drug companies return to the Hill to lobby former co-workers or employees. The deep ties raise concerns that pharmaceutical companies could wield undue influence over drug-related legislation or government policy.

“You’ll take the call because you’ve got a friendly relationship,” said Diana Zuckerman, president of the nonprofit National Center for Health Research and a former congressional staffer. “You’ll take the call because these people are going to help you in your future career [and] get you a job making three times as much.”

A 2012 Sunlight Foundation investigation found that, on average, a chief of staff on the Hill could increase his or her salary 40 percent by moving to the private sector.

Experts say the cozy relationships don’t necessarily mean congressional staffers do favors for lobbyists they know, but the access doesn’t hurt.

When John Stone left the House Energy and Commerce Committee last fall to join lobbying firm BGR, he told Politico that he had consulted with two lobbyists at BGR “for advice on basically everything that came across my desk.”

KHN’s review of Legistorm data indicates that one of the lobbyists, BGR’s Ryan Long, overlapped with Stone on the House panel. Brent Del Monte preceded them both on the committee and then spent 10 years at the Biotechnology Innovation Organization (BIO), a trade group for the biologic drug industry, before joining BGR in 2015. BGR’s clients include PhRMA, Celgene and other pharmaceutical firms.

Like Stone, Long and Del Monte, many ex-Hill staffers working in some way for the pharmaceutical industry came from key committees, including the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Energy and Commerce Committee, which in 2016 shepherded the 21st Century Cures Act into law. The law faced criticism from watchdogs who feared it would make drug approval cheaper and easier but could lead to unsafe approvals.

Tim LaPira, a James Madison University associate professor who co-authored a book about the revolving door published in June, said the practice of leaving government service to lobby for industry isn’t as corrupt as it seems. Rather, as congressional staffs have shrunk over time, they’ve been forced to essentially outsource expertise to lobbyists, he said.

“Don’t tell the private sector to stop doing it. Tell Congress to stop relying on the private sector so much,” LaPira said, adding that Congress spends just 0.5 percent of the discretionary budget on itself.

The number of congressional employees declined by more than 7,000 people — about 27 percent — from 1979 to 2015, according to data compiled by the Brookings Institution, a nonprofit research group.

While there’s a fear that lobbyists are slipping industry-friendly language into legislation, LaPira explained, more often they’re monitoring what’s happening inside government.

The reverse-revolving door, in which former pharmaceutical employees enter public service, is not as clearly understood. Neither is the flow of serial revolvers, who go from industry to government and back.

Some of those Hill staffers, according to financial disclosures, maintain drug industry pensions and stock, Kaiser Health News found. They are not required to divest and are required to disclose those connections only if they hold key positions.

Reverse revolvers may not realize they’re doing Big Pharma’s bidding, Friedly said, but they’ve been so exposed to the industry’s point of view that their implicit biases may seep into their legislative work.

The revolving door operates beyond the Hill, however, LaPira said

In addition to Azar, several former drug industry officials have landed key jobs in Trump’s Cabinet and administration, including Food and Drug Administration Commissioner Scott Gottlieb, a former venture capitalist with deep ties to the pharmaceutical industry.

Gottlieb disclosed serving on boards of several pharmaceutical companies, including GlaxoSmithKline and Daiichi Sankyo, prior to returning to government for his third trip through the revolving door.

KHN also reviewed the résumés of more than 100 HHS appointees, obtained via a Freedom of Information Act request by American Oversight, a nonprofit founded to hold government officials accountable. Although only a handful of recent appointees were employed directly by drug companies, more than a dozen had worked as lobbyists, consultants and lawyers on behalf of pharmaceutical firms.

The high-level HHS appointees include: Keagan Lenihan, a former lobbyist for drug distributor McKesson who now serves as senior counselor to the secretary at HHS; former PhRMA lobbyist John O’Brien, now deputy assistant secretary of health policy for the agency’s Planning and Evaluation arm; and former Bristol-Myers Squibb lobbyist Mary-Sumpter Lapinski, an attorney in the HHS secretary’s office.

Sen. Elizabeth Warren expressed concerns about the revolving door during Azar’s confirmation hearing before the HELP committee in November. Not long after telling Azar that his “résumé reads like a how-to manual for profiting from government service,” she asked him whether drug industry CEOs should be held accountable when the companies they run break the law. He did not answer yes or no.

His reply: “I’m satisfied with our discussion.”

METHODOLOGY

Kaiser Health News obtained revolving-door and lobbying disclosure data from Legistorm, a for-profit, nonpartisan congressional research firm based in Washington, D.C.

The revolving-door data include congressional staffers’ jobs on and off Capitol Hill. It is current through August 2017 and dates to 2001. For lobbyists who did not directly work for pharmaceutical firms but worked for lobbying firms on behalf of pharmaceutical companies and their trade groups, Kaiser Health News used lobbying disclosure data to identify individuals registered to lobby on behalf of these clients. Reporters then tracked down these lobbyists in Legistorm’s revolving door data and checked them by hand.

The HHS appointee résumés obtained by American Oversight covered individuals appointed from Jan. 20 to July 12, 2017.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Suzanne Robotti, MedShadow: January 16, 2018

MedShadow doesn’t often cover medical devices, but I’ll make an exception to point out this article about Stephen Tower’s experience with an artificial hip. This is a must-read for anyone who has or anticipates getting an artificial hip or knee — or any other body part.

Stephen Tower, MD, is an orthopedic surgeon experienced in performing artificial hip replacements. Yet he found out firsthand that the hip he requested to be put in his body was defective in its design. He then worked for years to bring attention to the harm that the metal-on-metal hip from Johnson & Johnson was causing.

The interesting part of the story is how that device — and almost all medical devices — got approved by the FDA. Essentially, a device manufacturer can file a form claiming that its product is “substantially equivalent” to an existing device. If the FDA agrees, that’s it. There’s no need for testing and no follow-up studies.

In some cases the “substantially equivalent” claim makes logical sense, but doesn’t work in real life — that’s why the clinical trial process exists. The author of the op-ed, Jeanne Lenzer, explored many examples and the history of the FDA in her new book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Save It. […]

I’ll give the last word to Diana Zuckerman, the president of National Center for Health Research (NCHR), an independent nonprofit that scrutinizes scientific and medical data and provides objective health information to patients, providers and policy makers. NCHR does not accept funding from device or pharmaceutical companies.

I asked Zuckerman for an example of a substantially equivalent approval that had particularly bothered her. She told me that the da Vinci Surgical System was “cleared for market” as substantially equivalent to the surgical tools it uses, such as a scalpel. But a robotic surgery system is more than just the tools it uses. The da Vinci robot was described by then-FDA Commissioner Jane Henney as the first of its kind and a product that “could change the practice of surgery.”

Although based on the 510(k) review process that rarely requires a clinical trial, the FDA required the first version of the da Vinci system to be studied in one clinical trial comparing the results to traditional surgery for gallbladder and reflux disease surgery. However, it and all future da Vinci robotic systems for all other surgeries were cleared for market by the FDA as substantially equivalent to the scalpel and other tools, and those later reviews didn’t require any clinical trials at all.

“How can a device be revolutionizing the practice of surgery and yet be substantially equivalent to tools that scientists tell us have been in use for more than 2,000 years? Does that make sense to any logical person?” […]

Read the original article here.