While we flit from story to story, post to post, that warn us of the dangers of the day, much of it exaggerated or imagined, the actual harm that is being done to us continues to escalate. And very few in the media are covering it. So much time is spent hashing over politics and “injustice,” but so little to our health, safety, and financial security. Corporate media does not give a crap about us, and we all know it.
Little attention is paid to women’s health, except when the rhetoric serves someone’s purpose, usually political or financial. The results of a study of tampons, the first such study ever undertaken, were recently released. Kind of strange, since they’ve studied just about everything else we put into our bodies and tortured and killed millions of test animals in the process, but no one thought to check to see if contaminated tampons might harm the women who use them or the babies born to them. Apparently, they didn’t want to touch those nasty old menstrual products from which they earn up to 70% in gross profit margin on the yearly sales in the US alone of $2 billion.
The study was performed by a team from UC Berkeley, Columbia University, and Michigan State University. They tested products available in New York City, London, and Athens.
Pesticide use has jumped dramatically since around the time biologist and environmental pioneer Rachel Carson published Silent Spring in 1962. We are bombarded with chemically soaked foods and fibers. Among the crops harboring the most concentrated amounts of herbicides and pesticides is cotton, the main component of tampons. The tissue of the vagina is delicate and more easily absorbs chemicals than the skin on other parts of the body, thereby increasing the danger.
The study found that there is no difference in the amounts of metals between organic and non-organic tampons. Fourteen brands and 18 products lines were tested, from both top sellers and store brands, and measurable traces of 16 toxic metals, including lead and arsenic were found, in every … single … one.
The U.S. Food and Drug Administration (FDA) classifies tampons as medical devices. Surely, they must do extensive testing, I thought. But no. As with so many other consumer products, they rely on the manufacturers, who have nothing but our health and safety at heart.
From the FDA website: “As part of the FDA’s review, manufacturers submit data including the results of testing to evaluate the safety of the materials used to make tampons and applicators (if present); tampon absorbency, strength, and integrity, and whether tampons enhance the growth of certain harmful bacteria or change normal bacteria levels in the vagina.” That’s like trusting a stranger to watch your kid.
Else Proulx wrote for Berkeley Public Health, “Metals have been found to increase the risk of dementia, infertility, diabetes, and cancer. They can damage the liver, kidneys, and brain, as well as the cardiovascular, nervous, and endocrine systems. In addition, metals can harm maternal health and fetal development.”
Women experience their periods for seven years of their lives on average. In addition, there is a mental cost for women who can’t afford these products, and there are approximately 500 million of them worldwide who experience “period poverty.” In some cultures women fashion their own menstrual pads and tampons. When I was young, I had an immigrant friend who taught me how to make pads from rags, and while that practice was normal in her country, most girls in the US used manufactured products when they had their monthly “curse.”
The European Union has much stricter standards than does our FDA. For example, they have banned ingredients in many personal care products that the FDA does not even regulate. Time to clean house and insist that the people we pay to watch out for us, actually do.
As I alluded to above, the government that extracts billions of taxpayers dollars relies on corporate oversight when deciding what is or isn’t good for us. If that’s the best these agencies have to offer, they should be abolished and actual scientists and scholars put in their place. Our bloated and ineffective federal oversight system is out of control, and this is just one example of how far away from their purpose they have strayed. We should be justifiably outraged.
In 2015, then-deputy commissioner at the Food and Drug Administration Robert Califf worked closely with pharmaceutical and medical device lobbyists on an industry-backed bill designed to accelerate the approval process for new drugs. Califf attended frequent meetings with individuals from Johnson & Johnson and other drug companies, as well as Pharmaceutical Research and Manufacturers of America (PhRMA) CEO Stephen Ubl, then at trade group AdvaMed, helping to jointly write legislative text that would become part of Republican Rep. Fred Upton’s (Mich.) 21st Century Cures Act, according to a report from InsideHealthPolicy based on a review of internal emails and documents.
When the 21st Century Cures Act passed the House, PhRMA’s Ubl released a statement praising it for including “reforms which enhance the competitive market for biopharmaceuticals and drive greater efficiency in drug development.” The bill relaxes some methodological standards for drug trials, for example by setting up a way for drug companies to submit “real world evidence” about their products’ safety and effectiveness, rather than information from double-blind randomized clinical trials.
Watchdog group Public Citizen blasted Claiff’s ties to industry in 2016, as he was facing confirmation to become FDA commissioner. “The attitudes he has developed over his decadeslong history of extensive financial ties to pharmaceutical and medical device companies leave him all too willing to promote the interests of regulated industries over those of public health and patient safety,” the group said in a blog post. “These entrenched attitudes do not befit the position of FDA commissioner.”
After leaving the government in 2017, Califf went to work as a consultant and compensated board member for several health industry companies including Cytokinetics, Bitterroot Bio, Centessa Pharmaceuticals, and Boehringer Ingelheim Pharmaceuticals. Since 2017, he has also worked as an advisor for Google and Alphabet’s life sciences research company Verily, according to his financial disclosure. He also returned to a job he held before his stint in the Obama administration at Duke University, where he told Time in 2015 that his salary was contractually underwritten by pharmaceutical companies including Merck and Bristol-Myers Squibb.
Califf has also amassed millions of dollars worth of pharmaceutical company stocks. His holdings include shares worth up to $500,000 in both Amgen and Bristol-Myers Squibb, up to $250,000 in Gilead Sciences stock, more than $2 million in Cytokinetics stock and options, and up to $5 million in Centessa stock options.
Now, Califf may be about to spin through the revolving door once again and take a job as the commissioner of the FDA, a position he held for nearly a year during the tail end of the Obama administration. President Biden nominated Califf in November for the position, and a vote by the Senate Health, Education, Labor and Pensions (HELP) Committee to send his nomination to the Senate floor is scheduled for Jan. 12.
Califf’s nomination was quickly celebrated by the pharmaceutical industry. “Congratulations to Dr. Robert Califf for being nominated as the next commissioner of the U.S. Food and Drug Administration” lobbying group PhRMA said in a statement. “It’s vital that we have a commissioner who understands the important role the FDA plays in promoting public health and providing science-based oversight of our nation’s medicine supply.”
But Califf’s confirmation is not certain. Democratic Sens. Joe Manchin (W.V.) and Richard Blumenthal (Conn.) have said they will vote against confirming Califf because of his ties to the pharmaceutical industry, and Sen. Ed Markey (D-Mass.), who voted against Califf in 2016, also appears to be leaning no. HELP Committee members Maggie Hassan (N.H.) and Ben Ray Luján (N.M.) have told reporters that they are undecided or have qualms. Vermont Independent Sen. Bernie Sanders, also a HELP Committee member, has also vowed to vote against Califf’s confirmation. “At a time when the American people pay the highest prices in the world for prescription drugs and as drug companies continue to be the most powerful special interest in Washington, we need leadership at the FDA that is finally willing to stand up to the greed and power of the pharmaceutical industry,” Sanders said in his statement opposing Califf’s nomination.
Even with these Democratic voting no, however, Califf may be able to squeak through and find the votes he needs to be confirmed because four Republican HELP Committee members have already told reporters that they plan to cross the aisle and vote for him. Each of these Republicans have entrenched pharmaceutical industry ties themselves, according to research provided by the Revolving Door Project and a Sludge analysis of campaign finance and financial disclosure data.
HELP Committee Ranking Member Sen. Richard Burr (R-N.C.) has told reporters he will vote for Califf and praised the former FDA commissioner at his hearing last month. “Dr. Califf’s unique perspective as a former FDA commissioner coupled with his understanding of partnerships with the private sector and academia that assist in fueling innovation will be vital if confirmed as the next FDA Commissioner,” Burr said in his opening statement.
Burr announced in 2016 that he is retiring at the end of 2022, but he has still received at least $173,600 from pharmaceutical and health products industry PACs since 2017, according to OpenSecrets. The industry has given his campaign and leadership PAC more money since 2017 than any other industry, including maximum donations from the PACs of companies including Abbott Labs, Merck, AstraZeneca, and Pfizer. Over the course of his entire Senate career, OpenSecrets says that Burr’s campaigns have taken in more than $1.6 million from the pharmaceutical and health products industry, including donations from company PACs and employees in the industry. That total makes Burr the third-largest Senate Republican recipient of money from that industry ever.
Burr, who is being investigated by the SEC for possible insider trading after dumping stocks following a confidential covid briefing in February 2020, has also sought to profit from personal financial holdings in the industry. A 2020 review of his trades by ProPublica found that Burr and his wife bought and sold up to $1.1 million worth of stock in companies that make medical devices, equipment, supplies, and pharmaceutical drugs.
Another Republican HELP Committee member that plans to vote for Califf, Sen. Tommy Tuberville (R-Ala.), is also an investor in many of the drug companies whose main trade association has applauded Califf’s nomination. In 2021, Tuberville bought and sold stock in Johnson & Johnson, Merck, Regeneron, West Pharmaceuticals, and Bristol-Myers Squibb. Some of these transactions were only disclosed by the senator months after they were made, a violation of the STOCK Act that requires financial transactions of members of Congress to be disclosed within 45 days. His annual financial disclosure shows holdings in several pharmaceutical and medical device companies as of the end of 2020 that he does not appear to have sold since, including Pfizer stock worth up to $150,000, investments worth up to $50,000 each in AmerisourceBergen, Abbvie, Allergan, and Eli Lilly, and smaller stakes in Zoetis, Edwards Lifesciences, and Novo Nordisk shares.
Sen. Susan Collins (R-Maine) has also told reporters that she is voting for Califf. Collins has benefited from $541,000 in contributions from the pharmaceutical and health products industry over the course of her career. The senator’s husband, former lobbyist Thomas Daffron, has up to $100,000 invested in the stocks of drug companies Johnson & Johnson and Merck, according to Collins’s 2020 annual disclosure. Collin’s 2020 campaign was chaired by pharmaceutical company lobbyist Josh Tardy, whose clients in Maine have included Eli Lilly and PhRMA, according to a report from Beacon.
HELP member Sen. Roger Marshall (R-Kan.), who initially told Politico on Dec. 17 that he would support Califf, has taken $102,000 in campaign contributions from the pharmaceutical and health products industry since first running for congressional office in 2016. His pharmaceutical PAC donors have included PhRMA member companies like Amgen, Pfizer, Boehringer Ingelheim, and Teva Pharmaceuticals.
Update, Jan. 7: In a note today, Sen. Marshall’s spokesperson says that he will not be supporting the FDA nominee.
If Califf’s nomination gets out of the HELP Committee, he is expected to easily be confirmed by the full Senate. His last confirmation in 2016 was approved by a vote of 89-4, with seven not voting.
Sen. Kyrsten Sinema, the controversial Arizona Democrat who threatens to derail President Biden’s legislative agenda, received more than $750,000 in donations from the pharmaceutical and medical device industries. After that, she announced her opposition to a Democratic plan to lower prescription drug costs.
Sinema told White House officials that she opposes House and Senate bills that would allow Medicare to negotiate drug costs, sources told Politico this week. Democrats estimate these bills would save $450 billion over the next decade and thereby pay for a large portion of President Joe Biden’s $3.5 trillion spending plan. The budget bill would expand child care, health care and paid family leave and would fund programs to combat climate change, among other measures. Three House Democrats have also balked at the plan, although they have offered a “centrist” alternative that would drastically limit which drugs are subject to Medicare negotiation. Sinema reportedly opposes that proposal as well. During her successful 2018 Senate campaign, Sinema repeatedlyvowed to lower prescription drug prices and drug costs for seniors.
Sinema is a longtime favorite of the pharmaceutical industry and now appears ready to undermine Biden’s entire agenda as Big Pharma wages a lobbying blitz in hopes of torpedoing the bill, which nearly 90% of voters support. Sinema and several House Democrats who oppose the drug pricing plan have received major financial support from the industry. Given a 50-50 Senate and a narrow House majority of 220 to 212 (with three seats currently vacant), their opposition could sink the proposal or even the entire budget bill.
Sinema has received $519,988 from PACs and individuals in the pharmaceutical industry throughout her political career, according to data from the Center for Responsive Politics. She brought in more than $120,000 in pharma contributions between 2019 and 2020 even though she is not up for re-election until 2024. Sinema has also received $190,161 from donors in the pharmaceutical manufacturing space and $62,797 from the medical supplies industry.
Sinema’s office is led by a former lobbyist whose firm worked on behalf of pharmaceutical companies. The senator’s chief of staff, Meg Joseph, was a registered lobbyist and principal at Clark & Weinstock, where her clients included the health insurer Health Net. During her tenure, the company also lobbied on behalf of numerous pharmaceutical companies, including Pfizer, drug distributor AmerisourceBergen Corp., and the biotech firm Genzyme Corp. It also lobbied on behalf of Pharmaceutical Research & Manufacturers of America (PhRMA) and AdvaMed, two major industry trade groups.
Sinema did not respond to questions from Salon. Her spokesman Josh LaBombard told Politico that she is committed to “working directly in good faith with her colleagues and President Biden on the proposed budget reconciliation package.”
He continued, “Given the size and scope of the proposal, while those discussions are ongoing we are not offering detailed comment on any one proposed piece of the package.”
Sinema got major backing from the industry before her threat to derail the Democrats’ drug bill. Center Forward, a Washington nonprofit that has received at least $4.5 million from PhRMA, has run TV and digital ads praising Sinema for the past two weeks, according to The Daily Poster, and sent out pro-Sinemamailers urging recipients to thank the senator for “fighting as an independent voice.” The group’s board includes at least two PhRMA lobbyists who work on drug pricing issues and represent numerous pharmaceutical companies.
Senate Budget Chairman Bernie Sanders, I-Vt., called out Big Pharma’s campaign to defeat the drug pricing legislation during a speech on Tuesday in front of PhRMA’s headquarters in Washington.
“The overriding motivation of the pharmaceutical industry is greed,” he said. “Their overriding goal is to make as much money as they can by squeezing as much as they possibly can out of the sick, out of the elderly and out of the desperate.”
Sinema isn’t the only Democrat who vowed to fight for lower drug costs before rejecting a plan that would do just that. Rep. Scott Peters, D-Calif., in 2019 praised the drug pricing plan but after receiving nearly $230,000 in the 2020 election cycle from the industry, as Salon’s Jon Skolnik reported, had an otherwise-unexplained change of heart. Earlier this year, he led a group of 10 House Democrats in opposing the bill in a letter to House Speaker Nancy Pelosi. “If you institute it, you won’t have cures because you’ll dry up all the private investment that does that research,” he told Roll Call after the reversal.
“That’s absolutely not true,” David Mitchell, founder of the independent nonprofit Patients for Affordable Drugs Now, said in an interview with Salon.
The claim that the bill would hinder development is a Big Pharma “lie” and “scare tactic,” said Mitchell, who suffers from multiple myeloma, a blood cancer treated with a combination of drugs that he said carry a price tag of more than $900,000 per year. “For me, as a patient with incurable cancer, it sounds very much like extortion, like the gun is at your head, ‘pay whatever we tell you, Mr. Mitchell, or you are going to die,’” he said. “It’s bullshit.”
Large pharmaceutical companies see profit margins that are much higher than other industries. A recent analysis by the nonprofit West Health Policy Center and Johns Hopkins Bloomberg School of Public Health found that Big Pharma firms could lose $1 trillion in sales over the next decade and still maintain their current research investments. A recent analysis by the Congressional Budget Office estimated that the Democrats’ bill would reduce the number of new drugs developed by about two per year over the next two decades.
“You’re talking about a tiny impact on new drug development,” Mitchell said. “We can compensate for that by sending more money” to the National Institutes of Health, he continued, “because NIH is the engine of innovative new drug development. It’s the single largest biomedical research agency in the world. All 356 drugs approved by the FDA from 2010 to 2019 are based on research, basic science from the NIH.”
Peters was one of three Democrats on the House Energy and Commerce Committee to vote against the Democrats’ drug pricing bill, along with Reps. Kurt Schrader of Oregon and Kathleen Rice of New York. A different committee later advanced the bill but the opposition appears to have enough votes to sink the measure — and the entire spending plan with it.
“I get that the pharmaceutical industry owns the Republican Party and that no Republican voted for this bill,” Sanders tweeted after the vote, “but there is no excuse for every Democrat not supporting it.”
Peters has received $860,465 from pharmaceutical PACs and employees, according to CRP data, the second most of any industry. He has already received $88,550 from the industry this election cycle, the most of any House member. On the day he sent the letter to Pelosi, Peters received big donations from the CEOs of Pfizer, Eli Lilly, Merck and Bristol Myers Squibb, as well as from lobbyists at PhRMA.
Schrader, who also signed Peters’ letter, has also received extensive financial backing from the industry. He has received $24,500 from pharma PACs and employees this cycle, the second most of any industry, and got $144,252 in 2020, the most of any industry. Throughout his career, Schrader, whose grandfather was an executive at Pfizer, has received $614,830 from the industry, according to CRP data. His former aide left earlier this year and quickly began lobbying for PhRMA, according to The Daily Poster.
Peters and Schrader did not respond to questions from Salon but they have introduced a supposed centrist alternative that would drastically limit the number of drugs whose prices Medicare could negotiate.
“It’s masquerading as a Medicare negotiation” bill,” Mitchell said, noting that it would exclude Medicare Part D drugs, which make up 83% of Medicare drug spending. The bill would only allow the agency to negotiate a “tiny, tiny sliver” of drugs covered under Part B that are administered by doctors and hospitals, he said, but would exclude drugs that are still in their period of exclusivity, which can last up to 12 years. “To call it Medicare negotiation is a fraud,” Mitchell said.
Kathleen Rice’s opposition to the bill is less easily explained, since she has not been one of the industry’s biggest recipients, collecting a relatively modest $84,000 in campaign contributions from Big Pharma sources, according to CRP data. Furthermore, Rice had twice previously voted for earlier versions of the plan and campaigned on lowering drug prices. In a letter to a constituent who expressed disappointment with her vote, Rice said that she supports “the goals” of the bill and “allowing Medicare to negotiate drug prices” but that she opposed the bill because it is being used “as a tool to offset the cost of a $3.5 trillion reconciliation bill.”
Rice cited opposition from Sinema and Sen. Joe Manchin, D-W.Va., over the bill’s price tag to justify her vote.
“That bill has no chance to become law, as Democrats in the Senate have stated that a bill with such a price tag will not have the votes to pass in their chamber,” she said in the letter, which was obtained by the American Prospect. That’s a strange and striking argument, considering that Rice voted for many other pieces of legislation that will go into a bill she says “has no chance to become law.”
“Rep. Rice believes the House should produce a reconciliation bill that can realistically become law,” Rice spokesman Stuart Malec said in a statement to Salon. “She supports Medicare negotiation, but the H.R. 3 drug pricing language in its current form does not have the support to pass the Senate. And Rep. Rice does not support advancing provisions that will jeopardize the bill’s final passage in the Senate.”
These large donations are only a portion of the pharmaceutical industry’s political spending aimed at defeating drug pricing legislation. Pharmaceutical companies have spent more than any industry on federal lobbying this year, shelling out $171 million so far in 2021, according to CRP, more than twice as much as the next biggest spending industry. Pharmaceutical companies spent $309 million on lobbying last year, the most ever. PhRMA alone has spent more than $15 million on lobbying and last week launched a seven-figure ad campaign to oppose the drug pricing plan.
“They’re pulling out all the stops to block this,” Mitchell said. “What they’re fighting to maintain is unilateral power to dictate the prices of brand name drugs to the people of the United States. They have the power to tell us what we’re going to pay and we just have to say yes. For them, it’s the ability to dictate the prices of drugs to patients like me.”
Patient advocates like Mitchell and advocacy groups like the AARP, Protect Our Care and Social Security Works are pushing back through lobbying and ad campaigns of their own.
“Pharma thinks this is just like every other time they have bent D.C. to their will with money, but it isn’t,” Alex Lawson, executive director of Social Security Works, said in a statement to Salon, noting that grassroots groups have spent years building a broad coalition of support among voters of all political persuasions. “And as for the Dems carrying water for Big Pharma, we are showing them the consequences of that. Their phones are ringing off the hook, there’s daily protests at their offices, and their local media is full of stories about their cozy relationships with Big Pharma.”
Lawson expressed optimism that Biden and Pelosi can get the legislation passed, given the widespread public support for this issue.
“Big Pharma is used to winning,” he said. “They’ve never gone up against a movement this powerful.”
Patients for Affordable Drugs Now has also launched an ad campaign targeting Peters’ and Rice’s districts, highlighting members of Congress for “choosing Big Pharma over patients.”
“We have the best opportunity that we’ve had in two decades to actually enact reforms that will meaningfully lower the prices of prescription drugs to the American people and stop subjecting us to the power of multinational corporations,” Mitchell said. “It’s an uphill fight all the way because we know who we’re up against. I think we have a really good shot of getting it done.”
John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.
So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.
Winkler returned home weeks later and, as he regained his strength, became hopeful about the future. He started making plans to visit colleges with his daughter, and was able to host his parents and new grandchild for Christmas. “He was doing so much better,” his wife, Tina Winkler, said. “We thought he was coasting until he got his transplant.”
What John Winkler didn’t know: Months before his implant, the Food and Drug Administration put HeartWare on notice for not properly monitoring or repairing HVAD defects, such as faulty batteries and short circuits caused by static electricity, that had killed patients. The agency issued a warning letter, one of its most serious citations. It demanded fixes within 15 days, but took no decisive action as problems persisted.
Ten days after Christmas 2014, Winkler’s two teenage children heard the HVAD’s piercing alarm and ran upstairs. They found their father collapsed on his bedroom floor, completely unresponsive. Kelly, 17, dropped to his side and tried to copy how people on television did CPR. She told her brother to call 911, and over the device’s siren did her best to hear instructions from the operator.
When paramedics arrived and assessed her father, one made a passing comment that has haunted Kelly ever since: “Well, his toes are already cold.” He died two days later. Medtronic, the company that acquired HeartWare in 2016, settled a lawsuit by the family last year, admitting no fault. Tina Winkler believes her children blamed themselves for their father’s death. “Those two kids have never been the same,” she said. “I think they feel like they didn’t do things they needed to do.”
But it was the FDA that failed to protect Winkler and thousands of other patients whose survival depended on the HVAD, a ProPublica investigation found.
As HeartWare and Medtronic failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so.
The HVAD was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards. By the end of last year, the agency had received more than 3,000 reports of patient deaths that may have been caused or contributed to by the device.
Among them were reports of deaths the company linked to serious device problems: a patient who vomited blood as a family member struggled to restart a defective HVAD; a patient who bled out internally and died after implant surgery because a tube attached to the pump tore open; a patient whose heart tissue was left charred after an HVAD short-circuited and voltage surged through the pump.
The ineffective regulatory oversight of the HVAD is emblematic of larger, more systemic weaknesses.
For decades, the FDA and its Center for Devices and Radiological Health have been responsible for ensuring that high-risk medical devices are safe and effective. Yet they mostly rely on manufacturers to identify and correct problems. The agency says it can seize products, order injunctions against companies or issue fines, but it rarely does so, preferring instead for companies to make fixes voluntarily.
When federal investigators found repeated manufacturing issues with the HVAD for years, the FDA didn’t penalize the company, even as the company issued 15 serious recalls of the device starting in 2014, the most of any single high-risk device in the FDA’s database. Thousands of patients with recalled models needed to have external HVAD parts replaced or take extra caution while handling their devices and monitor them for signs of malfunctions that could cause injury or death.
Meanwhile, the processes to inform the public through formal FDA notices and messages to healthcare providers repeatedly failed and left patients in the dark about known problems with the HVAD.
“Patients have no idea, and they rely on the FDA to ensure the safety and effectiveness of high-risk devices,” said Dr. Rita Redberg, a cardiologist at the University of California, San Francisco who studies medical device regulation. “How can you not take action on a warning letter with these serious issues with very sick patients?”
In response to ProPublica’s findings, the FDA said it had been closely monitoring issues with the HVAD. It said that after Medtronic acquired HeartWare in 2016, it met with the company more than 100 times to ensure problems were being fixed and to review safety concerns related to the heart pump. The agency also said it initiated formal reviews of new device modifications and continually tracked whether the HVAD had a “reasonable assurance of safety and effectiveness.”
“Our decisions that we made along the way have always been patient-focused,” said Dr. William Maisel, the director of product evaluation and quality at the FDA’s device division. He added that more than 80% of companies fix their problems by the time the FDA reinspects.
That did not happen with the HVAD. In 2016 and 2018, inspectors found that issues detailed in the 2014 warning letter remained unresolved. Medtronic told the FDA last year that it had fixed the problems, but, before the agency could verify the claim, inspections were paused because of the coronavirus pandemic.
In June, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
Medtronic declined to make CEO Geoffrey Martha or president of mechanical heart support Nnamdi Njoku available for interviews. In an email, a spokesperson said, “There is nothing more important to Medtronic than the safety and well-being of patients.”
The email continued, “Medtronic takes this matter very seriously and, over the past five years, we have worked closely with FDA and engaged external experts to resolve the issues noted in the warning letter. FDA is aware of the steps Medtronic has taken to address the underlying concerns.”
The company said it will have a support system in place for the 4,000 patients worldwide and 2,000 in the United States who still rely on the HVAD. Medtronic will station 20 specialists across the globe to help with device maintenance and patient education. A centralized engineering team will also provide technical support and troubleshooting for patients and medical staff. Medtronic said it will also offer financial assistance if insurance doesn’t fully cover the surgery to replace a device with a competing product, but only if a doctor decides it’s medically necessary.
Patients with HVADs have little choice but to hope the devices keep working: The surgery to remove HVADs is so risky that both Medtronic and the FDA advise against it. The device is meant to be left in place until its wearer gets a heart transplant. Or dies.
Warning Signs
In late 2012, HeartWare, then an independent company headquartered in Massachusetts, won FDA approval to sell a new device that could keep heart failure patients alive and mobile while awaiting a transplant.
A competing device, the HeartMate, was already gaining attention, with high-profile patients like former Vice President Dick Cheney, a heart attack survivor who eventually got a transplant after using the device for 20 months.
The patients who received HVADs had already been in grave peril. They had advanced heart failure, serious enough to need blood pumped out of their hearts artificially. Most patients were older than 50, but there were also younger patients with heart defects or other cardiac conditions. The device provided help but brought its own risks. Implanting it required invasive open-heart surgery, and clots could develop inside the pump, which, in the worst cases, led to deadly strokes.
The device also came with a steep price tag. Each HVAD cost about $80,000, and, even though HeartWare never made a profit as an independent company, in 2015 device sales brought in $276 million in revenue.
For many severe heart failure patients, the opportunity to survive longer and return to normal life made the device worth the risks and cost.
But patients were unaware the FDA started finding manufacturing issues at HeartWare’s Miami Lakes, Florida, plant as early as 2011, when the device was still seeking approval.
Among the findings, a federal inspector expressed concerns that engineering staff “were not completely reviewing documents before approving them” and found one employee assigned to monitoring device quality had missed several required monthly trainings. HeartWare leadership promised quick corrective action, according to FDA documents.
For example, HeartWare knew of 119 instances in which batteries failed unexpectedly, which could leave the pump powerless, stopping support for the patient’s heart. But the company didn’t test the batteries in inventory for defects, or the batteries of current patients, even though one person’s death had already been linked to battery failure.
The company also received complaints that static electricity could short-circuit its devices. It learned of at least 27 such cases between 2010 and 2013, including four that resulted in serious injuries and two that led to death. HVAD patients would need to avoid contact with certain household objects like televisions or vacuum cleaners — anything that could create strong static electricity. HeartWare added warnings to the patient manual and redesigned its shield to protect the device controller, but the FDA found that the company didn’t replace shields for devices already being used by current patients or produced and sitting in inventory.
Continuing quality control concerns led to the FDA warning letter in June 2014. The document labeled the HVAD as “adulterated,” meaning the device did not meet federal manufacturing standards. The agency gave HeartWare 15 days to correct the problems or face regulatory action.
Still, investment analysts who followed HeartWare believed the warning posed little risk to the company’s business prospects. One described it as being “as benign as possible.”
The 15-day deadline passed, and the FDA never penalized the company.
The agency told ProPublica it had provided additional time because HeartWare was a relatively new manufacturer and the HVAD was a complicated device. It also said it avoided punitive action to make sure patients with severe heart failure had access to this treatment option. “We’re talking about the sickest of the sick patients who really have very few alternatives,” Maisel, the head of device quality, said.
But the HeartMate, the competing device, was available and already being used by the majority of patients. When Medtronic stopped HVAD sales, both companies said the HeartMate could fill the gap.
Inspectors continued to find problems at HeartWare facilities in 2015, 2016, 2017 and 2018. In the most recent report in 2018, inspectors identified seven separate violations at the HVAD plant, including three previously cited in the 2014 warning letter. The company was still mishandling newly discovered defects like pins connecting the controller to a power source that could bend and become unusable, and controllers built with incompatible parts that could chemically react and “attack” the plastic exterior.
Again, the inspection report said the company “promised to correct” the issues.
“What penalty is there for noncompliance? There isn’t one,” said Madris Kinard, a former public health analyst with the FDA and the CEO of Device Events, a software company that analyzes FDA device data. “There’s nothing the FDA is doing that penalizes, in any true sense of the matter, the manufacturer.”
By the time sales were halted last month, the HVAD had become the subject of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death.
One recall came with a warning sent to health care providers in December that said pumps were failing to start up properly. The pattern of malfunctions was almost as old as the device itself, the company later admitted when it halted device sales in June. But even recent patients were completely unaware of the problem.
“A No-Brainer”
When children asked Latoya Johnson Keelen about the cable that came out of her side and connected to a controller on her hip, she told them she was Iron Woman.
For a while, she felt invulnerable with the HVAD on her heart.
Johnson Keelen, who lives in the Atlanta suburbs, learned she needed the device after delivering her fourth child, Isaiah, in early 2018. Doctors diagnosed her with postpartum cardiomyopathy, a rare and mysterious form of heart failure that afflicts mothers during pregnancy or after birth. Black mothers in the South have among the highest rates of the illness. Some mothers quickly regain heart function, some only partially recuperate and others never recover.
Tests showed that Johnson Keelen, then 42, was suddenly in end-stage heart failure.
Her body’s immune response at the time was too strong for her to receive a heart transplant. Doctors gave her two choices: an HVAD or end-of-life hospice care.
“It became a no-brainer,” she said. “I just had a baby. I just gave birth. I’m not ready to plan for a funeral.”
Johnson Keelen, a woman of faith, believed God would heal her, either through a medical advancement or a miracle. She thought the HVAD was the answer.
Living with a life-sustaining medical device was difficult at first for the fiercely independent mother. She had to leave her job as a public health communications specialist, ask her older sons to change her bandages and lean heavily on her new husband, only a year into their marriage.
But, for about three years, she found comfort in the soft humming of the HVAD’s spinning rotor at night. It served as a lullaby for her new baby when he lay on her chest.
She said she was never told about the manufacturing problems the FDA repeatedly found at HeartWare’s facilities or about device recalls, including one sent to patients in December 2020. The notice said the device sometimes wouldn’t restart properly, which had led to two patient deaths at that point. It warned that current patients should always keep at least one power source, a battery or an AC or DC adapter, connected at all times to avoid the need for a restart.
Two months after that notice, Johnson Keelen was getting her kids ready for school when the HVAD’s low-battery alarm blared. She had unplugged the battery to replace it without realizing her wall adapter was disconnected.
Once before, Johnson Keelen had simply plugged the charger back into the outlet and her device restarted. But this time it wouldn’t.
As an emergency alarm sounded, she called the ventricular-assist team assigned to her case, and a specialist directed her to switch out the device controller.
Nothing changed, and panic crept into the voice on the phone.
An ambulance took Johnson Keelen to a hospital where medical staff used several backup controllers to try to start the pump.
Still nothing.
Doctors and nurses tried to keep calm, but Johnson Keelen could see fear and shock on their faces. Without the HVAD, her only options were a transplant or a completely new pump.
Doctors scurried to locate a donor heart and airlifted her for an emergency transplant. But while running tests, the medical team was stunned to find that Johnson Keelen’s miracle had occurred: Her heart was once again pumping blood on its own.
She had a new choice. She could avoid the risks of transplant rejection and open heart surgery during the pandemic by leaving the device on her functioning heart, while cutting the wires, removing the external components and sealing the pump.
She chose to trust her newly functioning heart, and leave the decommissioned HVAD inside her.
Three months later, when Medtronic said it was stopping HeartWare sales and implants, its announcement cited the problem with pumps not restarting among the reasons.
Company-Led Oversight
If evidence suggests a medical device may be linked to a serious patient injury or death, hospitals and other health care facilities must submit a report to the manufacturer and the FDA. Device companies must also submit reports if they learn independently of any incidents.
By the end of 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA.
Any details that could identify patients, like their age or gender, are removed from the publicly available reports. Most only have limited details about circumstances surrounding deaths or injuries. But it’s clear from the reports on the HVAD that some of these outcomes could be linked to problems previously identified by FDA inspectors.
Doctors attempted CPR for two hours after an electrostatic shock short-circuited one patient’s device in 2014, a few months after the FDA inspection that year. An autopsy revealed voltage had caused “deep charring” of the tissue inside the patient’s chest.
Friends found another patient dead in the kitchen, with groceries still on the counter, in 2018 after their device, which did not have the recommended static shield, short-circuited.
Last year, paramedics found a patient with the device disconnected from power. They struggled to restart the device, but it wouldn’t plug back into the power source because the connector pins were bent. The patient would die at the hospital.
In most cases, the FDA turned to the company to investigate whether a malfunction caused or contributed to the incidents.
But the FDA has long known HeartWare and Medtronic could not be relied on to properly submit HVAD incident reports.
In 2014, the FDA cited HeartWare because in at least 10 cases, there were no documents showing the company attempted to investigate.
In 2016, the agency wrote another citation when the company was late in reporting more than 200 cases, some more than a year past their 30-day reporting deadlines, and failed to report malfunctions that occurred during clinical trials.
The FDA told ProPublica the agency increased its monitoring of HVAD reports, and Medtronic hired new employees to submit timely reports. But by 2018, its backlog had only grown, with 677 late case filings. Again, the FDA did nothing beyond telling the company to fix the problem and further increasing its monitoring.
In an email, Medtronic said it “has robust systems in place to monitor the safety of all of our products, including the HVAD device.”
The email said, “When any potential safety issues are identified, those issues are thoroughly investigated and relevant information is shared with regulators and healthcare providers.” The company didn’t respond to the pattern of late reports and incomplete investigations identified in FDA inspections.
Maisel, the director of FDA device evaluation and quality, once criticized asking companies to investigate their own devices. In 2008, as a practicing cardiologist, he testified to the U.S. House oversight committee about his concerns.
“In the majority of cases, FDA relies on industry to identify, correct and report the problems,” he said. “But there is obviously an inherent financial conflict of interest for the manufacturers, sometimes measured in billions of dollars.”
Maisel has since had a change of heart. When asked about his 2008 testimony, he told ProPublica that he now believes the regulatory system “generally serves patients well” and “most companies are well intentioned.”
HeartWare’s track record of questionable investigations was glaring in John Winkler II’s case.
A report submitted by HeartWare that matches the dates and details of Winkler’s case shows the company decided there was “no indication of any device malfunctions.” It told the FDA that the device couldn’t be removed from the body because the hospital said his family declined an autopsy. HeartWare added that the evidence of the device’s role in Winkler’s death was inconclusive.
Yet little of this appears to be true. Documents reviewed by ProPublica show an autopsy of the heart and lungs was performed a day after the death. Tina Winkler said she was told the pump was removed from her husband’s body and was available for inspection.
A year after John Winkler’s death, HeartWare recalled 18,000 potentially faulty batteries produced between 2013 and 2015. Tina Winkler came across the notice online and found her husband’s battery serial numbers on the list. The company never contacted her about it or any further investigation, she said.
Rewards, Not Penalties
As deaths and recalls mounted, HeartWare and Medtronic touted additional FDA approval to treat more patients and their attempts to develop new cutting-edge devices.
With the company on notice under the 2014 warning letter, HeartWare geared up to begin human trials on a smaller heart pump, called the MVAD or Miniaturized Ventricular Assist Device. It would be powered by a new algorithm to more efficiently pump blood. Industry analysts predicted robust sales.
In July 2015, implantations were set to begin on a select group of 60 patients in Europe and Australia. But they were abruptly stopped less than two months later after only 11 implants. Patients experienced numerous adverse events, including major bleeding, infection and device malfunction, according to published data.
HeartWare’s stock price plummeted from about $85 to $35 by October 2015. The next year, Medtronic bought HeartWare for $1.1 billion, replacing much of the company’s leadership shortly after.
Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD.
According to the accounts of six anonymous former employees in the lawsuit, the details mirror the scandal surrounding Theranos, the former blood test company charged with fraud for raising more than $700 million by allegedly lying about its technology.
Where Theranos made empty promises of a test that only needed a few drops of blood, the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
“Nothing really worked right,” one former HeartWare manager said in the lawsuit, citing “improper alarms, improper touch screen performance, gibberish on display screens — just so many alerts and problems.”
Leadership proceeded with human testing anyway, the suit alleges.
Months later, at an investor conference, HeartWare leadership acknowledged the pump and algorithm led to multiple adverse events. For two patients in particular, the algorithm would direct the pump to speed up so fast that it would try to suck up more blood than was available inside the heart for prolonged periods of time.
HeartWare and Medtronic settled the investor suit for $54.5 million in 2018, admitting no fault.
None of the allegations slowed the FDA as it gave Medtronic additional approval and support for its heart pump technologies.
In September 2017, the agency approved the HVAD as “destination therapy” for patients who were not heart transplant candidates and would rely on the device for the rest of their lives.
“We’re really excited about our HVAD destination therapy approval,” a Medtronic executive said on an investor earnings call. “That’s a real game changer for us in that market.”
Two years later, Medtronic announced it was developing a fully implantable version of the HVAD that would no longer need a cable coming through the waist to connect to power.
Even though issues with the HeartWare device had been unresolved for five years at that point, the FDA accepted the pitch into its new fast-track approval process for high-risk devices.
“Slipped Through The Cracks”
After Johnson Keelen’s pump failed in February, she found a news story about the recall notice sent to medical providers two months prior.
It said the company had identified a problem with pump restarts that could cause heart attacks or serious patient harm. Nineteen patients had been seriously injured so far, and two people had died. The recall warned that patients should be careful to avoid disconnecting the device’s power sources.
“I kept seeing Medtronic on record saying they notified patients,” Johnson Keelen said. “Who did they contact? No one told me.”
Her doctor later told her she must have “slipped through the cracks,” she said.
The current system for informing patients of new safety concerns with high-risk devices relies on a communication chain that can easily break. The device company contacts the FDA and health care providers that work with device patients. The FDA typically issues a public notice, while health professionals contact their patients.
But the agency admits most patients don’t know to look for formal FDA postings. And, experts say, the medical system can lose track of who needs to be notified, especially if a patient moves or switches primary care physicians.
Tina Winkler still wonders why she was never told about FDA-known safety issues with the HVAD. She said her husband’s medical team “had to teach me how to clean his wound, how to change his batteries and what to do if alarms go off. And they never mentioned any of this.”
She said, “If we had all the facts, there’s no way he would have gotten that device implanted in his heart.”
When FDA inspectors find serious safety issues with a medical device, inspection reports are not posted online or sent to patients. The public can obtain reports through a Freedom of Information Act request, but the agency’s records department has said new requests can be stuck behind a year-long backlog.
Patients can find warning letters online in a searchable database of thousands of letters from different FDA divisions, including the center for devices. But HeartWare’s 2014 letter is no longer available for public review because the website purges letters older than five years.
There are also few documents available in state courts about faulty products, because of restrictions on lawsuits related to medical devices. The restrictions date back to a 2008 Supreme Court decision in a case against Medtronic. The court found that U.S. law bars patients and their survivors from suing device makers in state court, essentially because their products go through such a rigorous FDA approval process.
Two recent patient lawsuits against HeartWare and Medtronic, including one filed by Tina Winkler, were moved from state court to federal court. In both cases, Medtronic filed to dismiss the cases because of the U.S. law that protects device companies. Medtronic and the families reached private settlements soon after.
Winkler and an attorney for the other family said they could not comment on their settlements.
Johnson Keelen, with a decommissioned HVAD still attached to her heart, wonders what that means for her and other patients’ chances of recourse.
“Why isn’t anyone now stepping up for the patient?” she asked. “They are now liable for taking care of us because we relied on them.”
“Run Its Course”
Deserae Cain, 33, is one of the 4,000 patients still relying on a HeartWare device.
She was implanted with the heart pump in late 2017, after suddenly being diagnosed with heart failure. Scans showed her heart was three times normal size. It took time for her to come to terms with needing a life-sustaining device — not long before her diagnosis, she had been going on five-mile runs. In the four years since, though, Cain has built a life around the HVAD with her fiance in their Dayton, Ohio, home.
They know the device can malfunction. In 2019, the pump failed for almost an hour as doctors at a nearby hospital struggled to restart it. Cain just tried to stay calm, knowing anxiety could threaten her unsupported weak heart. Months later, she needed an emergency experimental procedure to clear out blood clots developed within her HVAD.
Then, in 2020, Cain developed a widespread infection. Doctors told her she needed surgery to clean out and replace the pump.
Cain asked her medical team if she could switch to the alternative HeartMate device, which other patients told her presented fewer problems, she said. Doctors said the HVAD was better suited for her smaller frame.
But her new pump had problems soon after the surgery.
The device’s suction alarms, which alert when the pump is trying to pull in more blood than is available within the heart, sounded multiple times a day, for hours at a time, she said. Baffled by the issue for months, her medical team eventually turned off that specific alarm.
Soon after, her ventricular-assist specialist called her about a patient’s death linked to the belt that holds the device controller, she said. The belt had ripped and the equipment had fallen, yanking on the cable that connected the controller to the pump. Cain replaced her belt but it quickly frayed and had to be replaced again within six weeks.
Then, in June, she found out about Medtronic’s decision to stop sales and implants. Cain received a letter from her hospital mentioning a Medtronic support program, but it provided few specifics.
Cain wondered if things would be any different than before. Anxious about her future, she asked: “Are they just going to let it run its course until there is none of us left?”
