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. […]

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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.

Evan Lambert, Fox 5 News: September 18, 2017

A parents’ group known as Tireless DC tells FOX 5 that 11 artificial turf fields in the District have failed their most recent round of testing, leading to closures and replacements, and igniting another debate over the safety of synthetic turf.

D.C.’s Department of General Services (DGS) maintains and tests the 50 synthetic turf fields in the city. DGS did not make a list of the 11 failing fields available to FOX 5, but a task order from DGS shared with us shows the city is spending nearly $1 million to replace four turf fields at Janney, Eaton, Ross and Tubman elementary schools.

Q McCray, ABC 7 News: October 27, 2017

There’s no hiding 5-year-old Sam loves playing at Washington D.C. parks, but his mother can’t help but think what if.

“He fell about two and a half feet and broke his leg,” Eliza Graham explained.

Sam fell on one of D.C.’s older poured-in-place (PIP) crumb rubber floor playgrounds.

“No one in the District can speak to whether these playgrounds meet fall safety standards,” the mother of three added.

PIP and crumb rubber were D.C.’s flooring of choice for parks until a moratorium last year for health and safety reasons. One of them being attenuation.

Dr. Diana Zuckerman is President of National Center for Health Research.

“As they get older they get harder,” she said. “It can be extremely dangerous even deadly if a child falls.”

Manufacturers push “Gmax” testing to evaluate if PIP playgrounds are soft enough. Seven On Your Side found out D.C.’s Department of General Services (DGS) has never tested its rubber playground floors.

“Playgrounds do not fall under the Gmax testing for us,” DGS Director Greer Gillis said during a public hearing recently. “That’s one of the things we want to do in regards to playgrounds.” […]

Read the original article here.

Casey Ross, STAT News: September 12, 2017

The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.

The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.

The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.

Those recalls included life-sustaining equipment such as ventilators and infusion pumps, as well as a clinical decision support software used to flag adverse drug events during surgery.

“The FDA is allowing many of these products on the market with relatively loose criteria of what is acceptable, and those are the ones that are most likely to end up causing harm,” said Diana Zuckerman, a co-author of the study and president of the National Center for Health Research.

In a response to STAT questions, a spokeswoman for the FDA acknowledged that its review process needs to be updated to reflect issues posed by software-enabled devices.

“FDA’s traditional approach to medical devices is not well-suited to these products,” the spokeswoman, Stephanie Caccomo, wrote in an emailed statement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.” […]

Errors and Glitches

The study examined 627 software devices recalled over the five-year period between 2011 and 2015. Most of the recalled devices (592) were classified as presenting moderate risk; 23 were classified as low risk; and 12 were deemed high risk.

The high-risk recalls involved equipment used in several different settings. Six of the devices were used in anesthesiology, including five ventilators and one decision support tool. The study reported that the software glitches in the ventilators could cause them to stop working prematurely. The decision support tool, used to flag adverse drug events in surgery, could lead to the use of the wrong patient’s data during a procedure. […]

The Impact of Cures Act

The debate over the FDA’s scrutiny of medical software and digital health products is also being played out through implementation of the 21st Century Cures Act, which includes a provision that exempts certain software devices from the agency’s jurisdiction. Zuckerman said the exemption is a step in the wrong direction at the worst possible time, when rapid innovation is producing increasingly complex devices that require deeper scrutiny.

“Our Congress should not have passed a law lowering standards in a way that could be so harmful to patients,” she said. […]

Read the original article here.

Celia Wexler, Who What Why: September 7, 2017

In 2016, 10-year-old Joshua Hardy lost his long battle with cancer, in part because of a viral infection that resulted from a bone marrow transplant. Hardy’s family tried to get access to a new experimental antiviral drug from Chimerix, the company developing it. The company refused, not wanting to divert time and resources from its efforts to gain FDA approval for the drug. It agreed to make the drug available only after a social media campaign.

Hardy responded well to the drug, but it was too late.

Hardy’s story is one of those featured in the lobbying campaign for a federal Right to Try (RTT) bill, which passed the Senate in August and may soon get a vote in the House.

But the Senate-passed bill would not require drug companies to provide dying patients access to their experimental drugs. Instead, it largely goes after the Food and Drug Administration, and would remove FDA oversight from the process, while insulating the pharmaceutical industry and doctors from virtually any liability if patients are harmed.

RTT pits some desperate patients, along with libertarians and conservative and anti-regulation Republicans, including President Donald Trump and Vice President Mike Pence, against public health advocates, medical ethicists, and some national patient-advocacy groups.

The bill’s supporters frame the legislation as striking a blow for the rights of patients to try any drug without government interference. They predict that more pharmaceutical companies would give patients access to their unproven drugs if they weren’t worried about the FDA looking over their shoulders.

The bill’s opponents contend that any possible expansion of access comes at the cost of eliminating crucial protections for the most vulnerable patients, potentially hastening their deaths and making their end more painful.

Opponents are circulating a letter to the House this week charging that RTT should actually be called the “False Hope” bill. Indeed, given the philosophical bent of its strongest supporters, and their connection to free-market crusaders Charles and David Koch, RTT may be more about advancing a conservative, anti-government ideology than helping the terminally ill. […]

Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval. […]

RTT’s true beneficiaries may be new drug startups that are neither “patient-oriented nor compassionate, trying to create buzz for their product,” Zuckerman said. A biotech startup, she speculated, might be struggling with the high costs of making its product, and be happy to find wealthy, desperate patients willing to pay the freight. This might be particularly attractive since RTT gives patients only limited rights to sue, even if they are seriously harmed by defective products.

Unscrupulous doctors also might benefit, she added, since the law does not place any restrictions on the fees they may charge patients to administer the drug and monitor their progress. […]

Read the original article here.