Category Archives: In the News

FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem

Dan Vergano, Grid News, August 3, 2022


The departure of the head of the Food and Drug Administration’s tobacco science office for a job in the tobacco industry shines a new spotlight on a long-running problem: the “revolving door” between government regulators and the industries they police.

Matt Holman, whose work at the FDA influenced decisions around the safety of products such as e-cigarettes, left the agency Tuesday for a job with Philip Morris International, whose products — sold overseas — include Marlboro cigarettes and the electronic tobacco-delivery system IQOS.

Agency watchdogs say where there is smoke, there’s an ethics fire. They’ve warned of revolving-door concerns — only well-documented for high-level positions and for the Defense Department — for decades. But there is little hard data on just how big the problem is. A Grid analysis of LinkedIn profile data suggests that at least 2,700 ex-FDA employees now work for the pharmaceutical industry. Another 1,100 current FDA employees have moved the other way, from industry to the agency, according to the profile information.

Former FDA employees are found throughout many other industries regulated by the agency as well: Around 1,200 now work in the biotechnology industry, and more than 600 work in the medical devices industry. Some of the most high-profile examples include Trump FDA chief Scott Gottlieb, on the board of directors of Pfizer weeks after he left the job, as well as the current commissioner, Robert Califf, who went from heading FDA during the Obama administration to Alphabet Inc.’s health subsidiaries, and then back to heading the agency this year. Califf pledged not to work for a pharmaceutical or medical device firm for four years after leaving his current post to win the Senate votes he needed for his confirmation.

In a July 26 memo announcing Holman’s departure, newly installed FDA Center for Tobacco Products Director Brian King said that Holman had recused himself from tobacco-related regulatory decision-making and been on leave before July. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years,” said King.

The numbers are both interesting and not surprising, said Michael Carome of Public Citizen, a public health watchdog group based in Washington, D.C. The count likely underestimates the number of agency employees who have jumped to the industries they once regulated, he added, and obviously doesn’t include industry figures who have moved to the agency, where they briefly stay before returning to their home industry, another area of concern for ethics experts.

“Unfortunately, when you see somebody go from a regulating agency to the regulated industry, the public is naturally going to react like it’s a betrayal, because it does call into question your commitment to the mission of protecting the public,” said government ethics expert Walter Shaub of the Project on Government Oversight. While regulated companies may honestly want the expertise of the people charged with regulating them, said Shaub, “the other thing is that they want to know the inside workings of the FDA.”

“They want to, or one might suspect they want to, create an atmosphere in which employees at FDA know that there’s a lucrative job waiting for them, potentially, as long as they don’t really upset the regulated industry, right? I just think that’s human nature,” he added.

[….]

Regarding Holman, Philip Morris International said the former FDA official “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth,” in a statement sent to Grid.

Holman is barred from communicating with the FDA about Philip Morris for a year, under ethics rules, and about any matter he was personally involved with at the agency for life. In comments to the New York Times, Holman defended his move, noting that he consulted with agency ethics lawyers and viewed Philip Morris International as moving away from cigarettes to less harmful tobacco products, saying he could have jumped to the industry much earlier after 20 years at the FDA if that had been his goal. (He has not yet responded to a request for comment from Grid.)

However, numerous regulatory affairs or drug development employees at FDA-regulated pharmaceutical companies, including Merck, Abbott and Johnson & Johnson, worked at the FDA for more than a decade prior to moving to the industry, according to the LinkedIn data. “The idea that they recuse themselves is really BS, because they are telling the companies how to manipulate the system behind the scenes,” said Diana Zuckerman, president of the National Center for Health Research, herself a former Department of Health and Human Services employee.

Holman’s departure comes as the Biden administration has turned up the heat on the tobacco industry, planning to require slashing nicotine in cigarettes to minimally addictive levels, and moving to prohibit menthol cigarettes. A 2016 law has led to a crackdown on e-cigarettes, threatening small vaping shops and leading to a lawsuit with Juul after the agency last month ordered the e-cigarette maker to halt sales, despite allowing tobacco giant RJR to sell its own e-cigarettes. The agency’s tobacco and food safety programs are now under external review after the recent infant formula shortage and a surge in teens vaping nicotine since 2017.

“There have been a lot of strange decisions coming out of that office,” said Stanton Glantz, founding director of the UCSF Center for Tobacco Control Research and Education, a longtime tobacco industry critic, referring to the Center for Tobacco Products.

[….]

To read the entire article, click here.

Toxic chemicals lurk at playgrounds

Ariel Wittenberg, E&E News: July 8, 2022


When Diana Zuckerman was growing up, there was dirt underneath the slides. Her children played on playgrounds placed atop sand and mulch. But, today, when she drives around her Bethesda, Md., neighborhood, Zuckerman sees [many] rubber playgrounds.

The sight concerns Zuckerman, because as president for the National Center for Health Research she has testified in front of multiple municipal and even state governments about the toxic chemicals that can lurk in rubber playground surfaces.

The chemicals can include neurotoxins like lead and other heavy metals, as well as carcinogenic chemicals like polyaromatic hydrocarbons, endocrine-disrupting chemicals like phthalates, and chemicals linked to other organ damage like volatile organic compounds and PFAS, or per- and polyfluoroalkyl substances.

“All these rubber surfaces, they can be very pretty, and when you know nothing, you think it’s great because if my child fell on it, it is so spongy and pretty and safe,” she said. “But we actually don’t believe that it’s safe from the chemical exposure perspective.”

Concerns about modern playground surfaces were first raised decades ago, when recycled tire crumb rubber became a popular playground surface. The recycled tires often contained lead and other heavy metals, and public health experts were especially concerned that using the bite-sized material on playgrounds could unnecessarily expose small children, particularly toddlers, who are prone to putting objects in their mouths.

Nowadays, many municipalities searching for new playground surfaces know enough to stay away from tire crumb rubber.

But many continue to install what’s called “pour in place” rubber, flat, spongy rubber surfaces that can contain other chemicals of concern, like polyaromatic hydrocarbons, phthalates, and volatile organic compounds. Those more solid rubber surfaces can also contain additives and binders that could harm the health of children, though the exact chemicals vary by manufacturer.

Artificial turf, long-popular on athletic fields, has also been marketed as a playground surface. Some PFAS are used to manufacture the plastic grass blades (Greenwire, Dec. 8, 2021).

Sarah Evans, an assistant professor of environmental medicine and public health at Mount Sinai Hospital in New York City, says those poured in place rubber playgrounds still pose exposure risks to kids. Children could pick up chemicals on their hands as they play and then accidentally ingest them when they eat meals or snacks at the playground.

“We are very concerned about that,” she said. “And we don’t have a good handle of what is in those products.”

Indeed, the exact risks rubberized playgrounds pose to children are unknown, in part because the federal government’s efforts to investigate the issue have been stalled by both the Trump administration and the coronavirus pandemic.

In 2016 EPA completed a report looking specifically at tire crumb rubber playgrounds meant only to explain the best ways to test such surfaces for chemicals. A second report meant to characterize potential human exposure to tire crumb rubber has never been released.

[….]

In the absence of federal action, industry has continued to say that all playground surfacing options are safe.

[….]

Evans, at Mount Sinai, said she also hears from parents who are concerned that their cities and towns have already installed rubber playgrounds.

Playing outside, even on a rubber playground, can be very important for kids’ development. So, rather than eschew the playground altogether, Evans recommends that parents be extra vigilant if their children play on rubberized surfaces and make sure hands are washed before children eat or as soon as they get home. Kids who play on crumb rubber should shake out their clothes and change when they come home.

 To read the entire article, click here.

These machines to help people breathe were recalled a year ago. Many still use them

Emily Alpert Reyes, Los Angeles Times: June 23, 2022


In Rochester, N.Y., Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.

Her ventilator was among millions of breathing devices that Philips Respironics recalled last summer over safety concerns about numerous models of its ventilators, BiPAP and CPAP machines.

The reason: Polyester-based polyurethane foam used to muffle noise in those machines could degrade, giving off chemical gases and bits of black debris that could be swallowed or inhaled.

The possible risks: headaches, dizziness, nausea, irritated eyes and airways, and “toxic or cancer-causing effects,” according to federal regulators. The Food and Drug Administration put the recall in its most serious category, involving “a reasonable probability” that a product “will cause serious adverse health consequences or death.”

Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.

Coleman said her machine underwent some initial repairs, but she is seeking a new one after federal regulators sought more safety testing of the replacement foam used for such fixes. The 68-year-old, who is president and chief executive of the disability rights group Not Dead Yet, has a form of muscular dystrophy and uses her ventilator roughly 22 hours each day.

She is nervous about how it could affect her, but “it’s not like I can stop using it.”

[….]

The devices are commonly used to treat sleep apnea, a disorder in which breathing is repeatedly interrupted during sleep, which can increase the risk of heart problems and leave people dangerously drowsy during the day. The FDA has advised patients who use the recalled CPAP or BiPAP machines to talk to their doctors about whether to stop.

Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven’t had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.

[….]

“They’ve botched the whole thing,” said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, “some of them are still using the Philips because they don’t have a choice.”

Federal investigators have also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the company in regards to events leading to the recall.

Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.

“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”

But the actions that the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use,” Zuckerman said.

The FDA’s Center for Devices and Radiological Health told Philips last month that it was seeking to order the company to turn in a plan that could include not only repairing and replacing the recalled devices, but also providing refunds. In a November report, an FDA investigator found that Philips had failed to start taking appropriate action years earlier when the company first became aware the foam could be breaking down. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity, but the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath and black.”

[….]

This year, the FDA found that Philips’ efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. In March, it ordered the company to notify health professionals, device distributors and users of the recalled machines after estimating that only 50% of patients and consumers who had gotten recalled CPAPs and BiPAPs within the last five years had registered with the company for a replacement.

[….]

In Philadelphia, Meghann Luczkowski likewise worried about what would happen if Miles, her 8-year-old son, were switched to a different ventilator. Miles has a rare form of dwarfism that causes a “floppy airway” that needs to be reopened with mechanical ventilation. He had briefly been put on a different ventilator in the past but couldn’t maintain safe levels of oxygen and suffered “blue spells” in which his skin changed color.

His Philips machine has been “his lifeline,” allowing him to live at home with his family. But Luczkowski said they had begun noticing black buildup when they changed a filter in the machine.

“It’s a very scary thing to hear that the machine that keeps your child alive could suddenly be the thing that’s harming them,” Luczkowski said.

[….]

Concerns have continued to mount. From April 2021 through April 2022, federal regulators have gotten more than 21,000 reports about medical issues potentially tied to the recalled devices — or malfunctions likely to cause injuries if they recurred — including 124 reports linking them to deaths. Cancer has been a stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words “cancer,” “tumor” or “tumour,” said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices.

Those medical device reports, which can be submitted by health professionals and patients as well as manufacturers, do not require verification that the device caused the injury or death; Philips stressed that submitting such reports “is not evidence that the device caused or contributed to the adverse outcome or event.”

However, Zuckerman said “it’s assumed that a lot of deaths and other serious injuries don’t get reported at all.”

In La Quinta, Matthew P. Stone counts himself as relatively lucky. The 61-year-old, who had been using a Philips CPAP machine for sleep apnea, had been able to fall back on an old device from another manufacturer.

But Stone, like others, has been galled by the way the recall has played out. At one point, Stone said, he tried to lodge a complaint with federal regulators and was referred to a Southern California number that kept cutting out before he could leave a message.

“I am so incredibly disappointed,” he said, “at the lack of advocacy by anybody involved.”

To read the entire article, click here.

STAT Report : The need for speed and safety: A primer on the FDA’s drug approval pathways

By Kerry Dooley Young, March 2022

 


[….]

Only about 14% of drugs that advance as far as clinical trials eventually win FDA approval, researchers from the Massachusetts Institute of Technology reported in a 2018 paper in the journal Biostatistics. That’s actually an improvement from previous estimates that put the failure rate at about 90%.

Productive researchers can spend their careers at pharmaceutical and biotech companies without seeing any of their work result in a marketed product.

“I’ve been doing this for 27 years, and I have never once put a drug into a pharmacy,” Derek Lowe, a medicinal chemist and noted blogger, said in a 2016 interview with STAT.

[….]

ACCELERATED APPROVAL

In cases of fatal or serious illnesses such as cancer, the FDA allows sales of drugs through its accelerated-approval program based on promising results that only suggest a significant benefit for patients.

As of December 2021, the FDA had granted 278 accelerated approvals. But many of these were granted to the same medicines for multiple uses, or indications — so in total, only about 160 different medicines have won accelerated approval. Sometimes the designations pertain to different uses for the same drug.

An extreme example is Merck’s Keytruda cancer medicine. The FDA has granted more than 30 accelerated approvals of Keytruda, covering its use in more than a dozen forms of cancer. Keytruda also serves as a good example of why the accelerated approval process has been used so often for cancer medicines — and why there are growing concerns about this speedy pathway.

[….]

Since March 2021, Merck has voluntarily withdrawn two additional approvals granted for Keytruda.

The Keytruda withdrawals follow a public crackdown by Pazdur, the FDA’s top regulator of cancer drugs, on what he terms “dangling” accelerated approvals — cases where companies have not moved to seek the withdrawal of an accelerated approval after confirmatory trials fail.

[….]

Pazdur, who joined FDA in 1999, has been a champion of using accelerated approval, but he is insistent that the industry use the pathway the way it was intended. He’s been wrestling for years with drugmakers about standards for evidence, while also working to speed drug approvals.

“We have a litany of [drug companies] that come in and pose the question to us… ‘What is the lowest response rate that you will take? What is the fewest number of patients that you will take?’” Pazdur said during an FDA advisory committee meeting in 2004.

That’s not what the pathway is for, he made clear. “It wasn’t a license to do less, less, less, and less.”

[…]

AN OPPORTUNITY FOR CHANGE?

Expect intense political clashes in the months ahead as Congress works on a major new FDA law.

[….]

Under President Biden’s new FDA Commissioner, Califf, the agency has asked Congress to give it more tools to compel drugmakers to complete research promised after accelerated approvals. This includes a request to make companies demonstrate that they have adequate plans for confirmatory studies before winning accelerated approvals.

These kinds of steps are needed to restore the public trust in the FDA, said Diana Zuckerman, president of the National Center for Health Research, which closely monitors the agency.

 

“Califf will find it impossible to restore the FDA’s reputation if he focuses primarily on the need for faster approvals and more flexible approval standards,” Zuckerman told STAT.

 

“The commissioner needs to directly address the Aduhelm disaster, because the FDA leadership responsible for that decision are still in positions of power in the agency.”

 

The entire 30 page report is available from Stat here.

Will the FDA change how it vets drugs following the Alzheimer’s debacle?

Max Kozlov, Nature, May 13, 2022


Nearly a year after the US Food and Drug Administration (FDA) gave the green light to a controversial drug to treat Alzheimer’s disease, lawmakers are attempting to amend the process that led to its approval.

The House Committee on Energy and Commerce, which oversees drug safety and biomedical research, announced last week that it hopes to grant the FDA greater authority to rescind accelerated approvals if a company fails to complete follow-up studies on the treatment in a reasonable amount of time.

The provision, which was introduced as part of an FDA funding reauthorization bill, likely to be passed before September, comes on the heels of the agency’s 2021 approval of aducanumab, an antibody drug shown to reduce the accumulation of plaques in the brain associated with the progression of Alzheimer’s. Despite a nearly unanimous vote against the approval by an independent panel of experts, the agency fast-tracked the drug, which was developed by Biogen, a biotechnology company based in Cambridge, Massachusetts. Three advisory-panel members resigned in protest against the decision, and the approval is the subject of multiple investigations by federal regulators.

Aducanumab is not the only reason that this drug-approval pathway is coming under fire: since its inception, the programme has led to 279 treatments reaching the market, with nearly two-thirds in the past decade alone (see ‘Growing momentum for accelerated approval’). The programme’s increasing popularity signals a shift away from its original intent, says Diana Zuckerman, president of the National Center for Health Research, a non-profit organization in Washington DC. “Accelerated approval started out as a special programme for a small number of drugs, and now most cancer drugs are going through accelerated or some other expedited pathway,” she says.

Companies, moreover, have been slow to produce the follow-up studies promised as part of the approval process. The FDA has limited power to compel them to provide the data, but the legislative proposal — which could still change significantly as it wends its way through the House of Representatives and the Senate — could grant it more authority to do so.

Days before his appointment in February, FDA commissioner Robert Califf pledged to make accelerated-approval reform a priority for the agency. Researchers who spoke to Nature agree that reforms are needed to protect the integrity of the programme, and that the proposed legislation is a good start. But they also recommended more agency oversight and other changes that would further prevent pharmaceutical firms from abusing this route to the market.

“Instead of the drug companies living up to and working to ensure that they are employing the accelerated-approval pathway as intended, we have too many that are willing to take advantage of the loopholes where they can find them,” says David Mitchell, president of Patients for Affordable Drugs, a non-profit organization in Washington DC, who serves as a consumer representative on the independent panel that reviews cancer drugs for the FDA.

The need for speed

The FDA created the accelerated-approval pathway in 1992, largely in response to the HIV–AIDS crisis, to get urgently needed drugs to the market without delay. Instead of demonstrating efficacy through clinically-meaningful endpoints, such as patient survival or reduction of symptoms, drug candidates reviewed under this pathway often rely on what are known as surrogate endpoints, which may be faster or easier to track than conventional clinical-trial endpoints. For example, tumour shrinkage is a common surrogate used in cancer-drug clinical trials, but this metric is not necessarily linked to a direct benefit to patients.

Gregg Gonsalves, an epidemiologist and global health specialist at Yale University in New Haven, Connecticut, was among the group that persuaded the FDA to adopt this programme. “We pushed for this accelerated approval pathway because people were dying,” he says. “I’m HIV positive, so I get the desperation and need for hope.”

The pathway has turbocharged the number of immunotherapies and cancer treatments on the market. But some of these drugs cost hundreds of thousands of dollars per year, despite, in many cases, limited data showing their clinical utility. Gonsalves argues that the programme has been co-opted by the pharmaceutical industry to speed approvals. Cancer treatments approved through the pathway have made it to market on average about three years earlier than they would through standard routes. And a single study using surrogate endpoints could be enough to get a treatment on the market.

Part of the problem, says Caleb Alexander, an internal-medicine specialist and epidemiologist at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, is that drug companies aren’t upholding their end of the bargain with timely post-market studies confirming the benefits of the drug. Some researchers question whether companies are given too much time to produce such data. A 2021 analysis found that 13% of drugs granted accelerated approval between 1992 and 2016 hadn’t been converted to full approval within five years — and remained on the market for a median of 9.5 years without the data needed for conversion.

[….]

Post-market trials can take a long time, especially for slowly-progressing conditions such as neurodegenerative diseases, says a spokesperson for the Rare Disease Company Coalition, an organization in Washington DC that represents 21 pharmaceutical firms.

It is also difficult for companies to recruit participants, because people would much rather be guaranteed an approved medicine than risk getting a placebo. Instead of demanding that a company stop selling a drug that hasn’t been converted to full approval, says Zuckerman, the agency often requests that the company voluntarily withdraw it from the market. “The FDA loses an enormous amount of leverage once a product is approved,” says Alexander.

[….]

How effective the proposed rule changes for the US FDA would be is unclear. Although they would make it easier for the agency to withdraw approval, they would also lengthen the bureaucratic process of rescinding approvals. This defangs the provision, Zuckerman says. She would have preferred to stick with an earlier proposal, which would have automatically revoked approvals once confirmatory trials were one year overdue.

Zuckerman also recommends that the FDA commissioner’s office create a separate independent advisory group to review agency approvals that go against advisory panel recommendations — as happened for aducanumab. “The vast majority of advisory-committee votes recommend approval, so when they don’t recommend approval, there’s usually a really good reason,” she says.

Alexander suggests using health-care coverage as leverage. The US Centers for Medicare & Medicaid Services (CMS) in Baltimore, for example, decides which treatments will be funded for tens of millions of US residents. Earlier this year, concerned about the efficacy of aducanumab, the CMS stated that it would cover the annual US$28,800 cost of the drug only for people enrolled in clinical trials.

Although that decision is nearly unprecedented, Alexander thinks that the CMS should consider a lower reimbursement rate for other accelerated-approval treatments that have not yet gained full approval. Such a move could “light a fire underneath manufacturers” to complete their trials, he says. “Why should taxpayers be on the hook for paying the full price of a drug when we don’t know the full scope of its safety and effectiveness?” he asks.

[….]

Reform won’t be simple. Once a medicine enters the market, Mitchell says, “drug companies aren’t anxious to find a reason to take it off”.

Still, many researchers and drug-safety advocates are eager to see change. “We started out trying to fix a pendulum that was too far in one direction,” says Zuckerman, “and look how far we’ve come in this direction now.”

To read the entire article, click here.

Danica Patrick reveals she had breast implants removed after suffering complications

Katie Kindelan, Good Morning America, May 2, 2022


Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants.

Patrick, who turned 40 in March, shared in an Instagram post that she had her implants removed this month, nearly eight years after undergoing breast augmentation surgery.

“I wasn’t sure I was ready to share this…. but then I remembered that true vulnerability is sharing something you’re not really ready to. So here it is,” Patrick wrote on Instagram, before going on to describe the complications she said she faced.

Patrick said she first noticed complications about three years after getting breast implants, including weight gain and hair breakage.

Nearly two years ago, at the end of 2020, Patrick said the “wheels came off” with her health.

“I had cycle irregularity, gained more weight, my hair wasn’t looking healthy at all and my face was a different shape (weird I know),” she wrote, adding that she also faced dizziness, adrenal fatigue, hypoglycemia, leaky gut and more. “So I went down the rabbit hole to figure it out. I did every test that could be done.”

Patrick wrote that she went to multiple doctors, took thyroid medications, tried a 90-day protocol to heal her gut and at one point was taking “up to 30 pills a day” to improve her health, all to no avail.

Ultimately, Patrick said she came to the conclusion that she had breast implant illness, a term coined by clinicians and patients to describe symptoms reported by women after breast reconstruction or augmentation using implants, according to the Food and Drug Administration.
After undergoing surgery to remove the implants, Patrick said she quickly noticed improvements to her health.

“Within hours after surgery this is what I noticed – my face had more color and less dark circles … my face started producing oil again,” she wrote. “I could take a 30% deeper breath into my chest already, and I had so much energy when I woke up.”

[….]

What to know about breast implant illness

Breast implant illness is not yet a recognized medical term but is described by experts as a “diagnosis by exclusion,” according to Diana Zuckerman, Ph.D., president of the National Center for Health Research, who has studied the health impact of breast implants for over 30 years.
“Diagnosis by exclusion means that there is no test for it, but there are tests for other things that have the same symptoms or similar symptoms,” Zuckerman said. “And if there is no other reason for this array of symptoms, then there are doctors who will call it breast implant illness.”

There are as many as 40 symptoms of breast implant illness, but the most common symptoms include joint and muscle pain, fatigue, memory problems or brain fog, hair loss and difficulty breathing, according to Zuckerman.

She said Patrick’s story of taking years to get to a diagnosis is not uncommon for women who suffer health complications due to breast implants.

It can take years for breast implants to start causing complications, which makes it more difficult to link complications back to breast implants, according to Zuckerman, who was not involved in Patrick’s care. She also noted that many of the symptoms of breast implant illness can, and are, attributed to other things.

“When [women] go to the doctor and say, ‘I have joint pain. I’m really tired,’ the doctor will say things like, ‘No wonder you’re tired, you have a young child,’ or, ‘No wonder you’re tired, you’re 45 years old. You’re not 25 years old anymore,” said Zuckerman.

“So there’s been this, some might call it gaslighting, but this sense that these are common symptoms and they could be anything,” she said. “But, what is distinct about them is there are so many women who are experiencing them, and there are very good studies showing when women have these symptoms and they have their breast implants taken out, almost all of them get better.”

Breast implant surgery is considered an elective procedure that is done not only for cosmetic reasons but also for women undergoing breast reconstruction after a medical procedure such as a mastectomy.

Saline-filled and silicone gel-filled are the two types of breast implants approved for use in the United States, according to the FDA.

Breast implants may cause damage if they leak in the body, or because they can cause scar tissue to build in the body, according to Zuckerman.

“When women have a breast implant, their body almost always forms a scar tissue capsule around the implant,” she said. “The body is basically protecting itself by surrounding this foreign body, this breast implant, with scar tissue, and that scar tissue can get very thick and can get very hard and be a bad symptom in that it can be painful.”

Zuckerman said that the popularization of social media has helped women with similar symptoms connect and share their experiences, leading to greater awareness and more diagnoses of breast implant illness.

Patrick wrote on Instagram that she watched “over 100 stories on YouTube” of women with breast implant complications.

“Social media has really made the big difference here,” Zuckerman said. “It wasn’t until Facebook and other social media options became available that women could really share their stories.”

“We’ve certainly known women who’ve spent tens of thousands of dollars on tests and specialists, and nothing helped and then they went online and found a Facebook page or some other social media, and they started reading these stories of other women that sounded just like them,” she said.

[….]

Zuckerman, a member of the working group that advised the FDA on implant safety, said she advises women who are thinking of getting implants to make sure they also have the resources to get them removed later on if needed.

“Don’t get them unless you can afford to have them taken out,” she said. “A lot of women spend all this money getting them put in, and then when they get sick, they don’t have the money to get them taken out. It costs just as much, sometimes more, to have them taken out.”

To read the entire story, click here.

What’s Wrong with the FDA?

Shannon Brownlee and Jeanne Lenzer, Washington Monthly: January 20, 2022


If Robert Califf, the White House nominee for commissioner of the U.S. Food and Drug Administration, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. Meanwhile, about a third of Americans refuse to get vaccinated for COVID-19, in part because they distrust government and scientific institutions.

In the case of the FDA, at least some of that mistrust is deserved even if the COVID vaccines are generally safe. (We’ve both taken them.) The most recent FDA disaster erupted in June, when officials approved the Alzheimer’s drug Aduhelm over the objections of the agency’s biostatistician and an 11-member committee of expert advisers. The data submitted by Biogen, the drug’s manufacturer, failed to show that Aduhelm is effective. It also poses a significant risk of harm, including brain bleeds and swelling in about a third of test subjects. Agency higher-ups decided to overlook these shortcomings and put the drug on a fast track for approval.

[….]

The Aduhelm debacle and other FDA blunders can be traced to declining scientific standards at the agency and increasingly cozy ties with the companies it regulates.

[….]

All of which suggests there’s not much chance that Califf would be the reformer the FDA needs. With eternal hope that the full Senate will reject him or, if he’s confirmed, he and the White House will pursue a reform agenda, we talked to several experts about their priorities for fixing the agency. In their view and ours, the following represent the top five actions that need to be taken.

1. Enforce commitments made by drugmakers.

The FDA awards expedited or fast-track approvals for drugs with a promise by the manufacturer that it will conduct further, more rigorous studies. However, by 2018, according to a recent review, companies followed through on only 38 percent (166 of 437) of drugs.

[….]

2. Rescind the approval of drugs that cause harm but don’t benefit patients.

When follow-up studies show that drugs are ineffective or dangerous, the FDA needs to pull them. Right now, drugs are still being prescribed to patients even though rigorous clinical trials have shown they don’t work. The agency recently allowed four out of six widely used (and heavily advertised) cancer drugs to stay on the market after their follow-up studies failed to show any benefit. Only five of 54 costly, toxic cancer drugs approved by the agency between 2008 and 2012 improved survival rates.

[….]

3. Restore rigorous scientific standards.

Many experts, including multiple FDA insiders, have complained about the progressive decay of scientific standards at the agency. This has only gotten worse since 2016, with the passage of the 21st Century Cures Act, which gives the FDA enormous leeway in what kinds of studies it demands of companies in order to get their drugs approved. The FDA needs flexibility, says Steven Goodman, associate dean of clinical and translational research at Stanford, “but it has been erring on the side of lowering the scientific bar.”

For most drugs, companies should be required to produce two randomized clinical trials, the gold standard of medical science, showing that the drug provides meaningful benefit. Fewer drugs should be approved based on a “surrogate marker,” often an imaging study or blood test that is affected by a drug but may have little to do with whether or not patients benefit. “Too many FDA decisions have been based on wishful thinking rather than medical evidence,” says Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based public health think tank.

4. Clean house.

Somebody needs to jam the revolving door at the FDA. Physicians, scientists, and administrators come to the agency from industry, push industry-friendly decisions, and then leave government for new, lucrative positions in the private sector.

Take Patrizia Cavazzoni, the head of the FDA Center for Drug Evaluation and Research, who oversaw the approval of Aduhelm. Before joining the agency in 2019, Cavazzoni spent nearly two decades in high-level positions with the pharmaceutical giants Pfizer, Eli Lilly, and Sanofi-Aventis. After overruling the FDA advisory committee’s resounding vote against Aduhelm, she suggested that industry “partner” with the FDA in choosing committee members, an idea that violates the whole point of having outside, independent advisers.

[….]

5. Stop Big Pharma financing.

Finally, President Biden should call on Congress to fully fund the FDA by repealing the legislation mandating that the drug industry pay for its own reviews. “What really needs to happen is to mitigate the power that Pharma already has over the FDA,” says Erick Turner, professor of psychiatry at Oregon Health & Science University and a former member of an FDA advisory committee. That can’t happen as long as the FDA is dependent on industry money.

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To read the entire article, click here.

Biden’s ‘Cancer Moonshot’ Turns Toward Pollution

Ariel Wittenberg and Nico Portundo, E&E News: February 3, 2022


President Biden made an emotional pledge yesterday to “end cancer as we know it” by reinvigorating the Cancer Moonshot initiative he first launched in 2016, just one year after his son Beau succumbed to the disease.

“I committed to this fight when I was vice president. It’s one of the reasons, quite frankly, why I ran for president,” Biden told a room of cancer patients, survivors, caregivers, researchers and advocates.

A lot has changed since Biden first launched the program. This moonshot doesn’t come with any new funding, for example, but the White House says recent progress in cancer therapeutics, diagnostics and patient-driven care, as well as public health lessons learned during the Covid-19 pandemic, mean the initiative can be successful.

Another change in the renewed moonshot: an acknowledgment that environmental exposures can cause cancer.

While the previous Cancer Moonshot largely focused on funding research for treatments and cures for cancer, the renewed effort—whose goal is to reduce cancer death rates by 50 percent in the next 25 years — includes multiple initiatives to prevent cancer.

That includes addressing pollution.

“President Biden described seven areas of focus in which to make progress to end cancer as we know it today,” White House Cancer Moonshot Coordinator Danielle Carnival told E&E News in a statement. “Cancer prevention is one of those pillars and limiting exposure to carcinogens is an important part of preventing cancer.”

[….]

Though many in the environmental health field have long understood that chemical exposures can cause cancer and change peoples’ cancer outcomes, that fact hasn’t always been acknowledged by the broader medical community, which has focused more on genetic causes (Greenwire, May 4, 2021).

Linda Birnbaum, who formerly lead the National Institute of Environmental Health Sciences, told E&E News that she “tried really hard” to get the agency involved in the first moonshot initiative but was met with resistance from the National Cancer Institute.

“Environment is just not something they think about,” she said. “I’m glad to see it is at least mentioned this time.”

[….]

‘Just one sentence’

Indeed, cleaning up pollution is just one part of one of the new moonshot’s goals, which also include diagnosing cancer sooner, preventing cancer, addressing inequities, targeting the right treatment for each patient, and ramping up progress against rare and childhood cancers, among other things.

Environmental health experts were quick to note that merely acknowledging chemicals’ impact on cancers is only a first step, and say that the administration would have to do a better job at curbing pollution in order to truly “end cancer as we know it.”

In all of the pomp and circumstance surrounding the new moonshot’s launch, the experts note that environmental factors were mentioned just once in a fact sheet, and not at all in remarks from the president, vice president or first lady. Rather, much of the White House material on cancer prevention focuses on whether the mRNA technology used in Covid-19 vaccines to teach the immune system to respond to the virus could also teach bodies to stop cancer cells when they first appear.

“mRNA technology, yes, let’s spend as much money as we can to try and develop that vaccine, and maybe it will work,” said Diana Zuckerman, president of the National Center for Health Research. “But if you really wanted bang for your buck, you would want to look at environmental issues where prevention will really improve peoples’ health and reduce cancers, and that’s just one sentence here.”

Julie Brody, executive director of the Silent Spring Institute, said she wanted the moonshot to “take a bigger approach to prevention and environmental chemicals in particular,” citing a “revolution in how we think about causes of cancer” since the previous moonshot was launched.

[….]

But when White House officials discussed cancer prevention in a call with reporters earlier this week, environmental issues didn’t come up at all.

“We know cancer is a disease where we have too few effective ways to prevent it,” said one senior administration official. “There are some: don’t smoke, for example. But we don’t have lots of effective ways right now to prevent cancer.”

American Lung Association Senior Vice President for Public Policy Paul Billings agrees that there’s not one chemical like tobacco that could be the focus of prevention efforts. But, he said, “If you really want to end cancer as we know it, we do need to deal with things like environmental exposures.”

[….]

To read the entire article, click here.

Covid Booster Costs Spur Calls to Shift From Free Jabs for All

Celine Castronuovo, Bloomberg Law, April 11, 2022


The U.S. government’s Covid-19 vaccine funding may have to shift from a model of free shots for all to one in which the government only subsidizes boosters for targeted populations, public health analysts say.

Annual Covid-19 boosters for all Americans, tailored to the prevalent virus strain, would cost billions of dollars each year and may not be the most sustainable and effective path in responding to future variants. Analysts say reserving booster recommendations to those most at risk would be more cost-effective.

“Given the much greater expense of Covid boosters compared to flu shots and the time needed to revise and manufacture Covid vaccines, we need to hope we won’t need annual shots,” said Diana Zuckerman, founder and president of the National Center for Health Research.

It “would make sense to prioritize by focusing efforts to persuade and administer boosters to those most likely to benefit,” she said.

If the Biden administration were to purchase enough second-round booster doses for all eligible Americans, it would need to secure as much as $9.4 billion in additional funding, according to a Kaiser Family Foundation analysis.

[….]

“The provision of vaccines on a long-term basis is probably going to devolve back to our fractured private and public sectors, instead of being paid for exclusively by the federal government,” said Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst at Health GAP, an advocacy group focusing on equity in access to HIV medications.

Health policy watchers say the general population could need additional boosters if more infectious and deadly variants emerge. But existing evidence on booster efficacy and the price tag for shots in every American arm means the federal government should prioritize updated vaccines for older and immunocompromised people, and vulnerable populations elsewhere, they say.

[….]

Vulnerable Populations

Lower infection severity among younger populations, and waning enthusiasm for additional shots support an approach of prioritizing older and other higher-risk Americans in booster campaigns, analysts say.

“We are likely to only boost those who are vulnerable every year against COVID-19, unless we get a more deadly variant, in which case we will all need a booster shot that year,” Monica Gandhi, an infectious disease doctor and professor at the University of California, San Francisco, said in an email.

Gandhi argued that the U.S. should follow the example of countries like Germany and Sweden, which have only recommended fourth doses for adults ages 70 years and older. She cited an Israeli study that didn’t show a fourth dose substantially benefited health-care workers under the age of 65.

“The need for further doses of the vaccine to boost antibodies will depend on clinical characteristics of the individual that may predispose to severe breakthrough infections,” like underlying health conditions, Gandhi said.

Only 45% of fully vaccinated Americans have received a first booster dose so far, according to CDC data. “The administration should not assume that everyone needs boosters now or will get them even if they need them,” Zuckerman said.

Purchasing doses at levels higher than existing demand would also mean unnecessary waste, Gandhi said. “Shots do expire, so purchasing them and having them go to waste is a waste of taxpayer money,” she said.

Instead, the administration could wait on additional research on multi-variant vaccines in development before recommending additional boosters to lower-risk people, Baker said.

“It’s a question of balancing current risks and against the possible benefits of recalibrated vaccines,” Baker said.

Long-Term Costs

Policy analysts also see a situation in the future in which the federal government no longer purchases doses directly from Pfizer and Moderna.

Providing boosters via health insurance, though, could exacerbate existing health inequities, said Leighton Ku, director of The George Washington University’s Center for Health Policy Research. “What’s terrible about Covid, and frankly speaking so many diseases, is people who are poor and vulnerable get hit the hardest.”

“I’ve always worried that the people who are uninsured are people who are low income and who are more vulnerable in so many ways,” Ku said.

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To read the entire article, click here.

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022


PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

  • Breast implants are not considered lifetime devices
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  •  BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
  • Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

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To read the entire article click here.