Fox & Friends: August 17, 2019.
As a rising number of teens are hospitalized after vaping, Dr. Diana Zuckerman urges parents to take action:
“A lot of parents don’t know their kids are vaping, and secondly, even if they know it, parents don’t realize how often kids are vaping.”
See the full segment here.
Caitlin O’Kane, CBS News: August 13, 2019.
In Wisconsin, at least a dozen people have recently been hospitalized and treated for severe lung damage. The first cases were reported last month, and the number has been growing. All of these patients are young — between their teenage years and 30s — and all of them appear to have been harmed by vaping.
Wisconsin’s Department of Health Services confirmed 12 cases and is investigating 13 others, including older patients up to their 50s who are experiencing lug damage as a result of vaping, according to The Milwaukee Journal Sentinel.
The hospitalization of at least a dozen young people raises the question: How have e-cigarettes caused so much damage, when they haven’t even been around for that long?
“It’s mind-boggling,” Dr. Diana Zuckerman, president of the National Center for Health Research, told CBS News. “The vast majority of people who smoke started as children or as young teens, and yet you don’t hear about people getting lung cancer until their 40s, 50s, 60s,” she said. “Think about that compared to what’s happening to these kids now. I’ve never heard of a smoker ending up in the hospital in their teens.”
Zuckerman pointed to one specific case: a college freshman from Florida whose lung collapsed. In an interview with The Daily Mail, the teen admitted to vaping about one JUUL pod every two days for a year.
“Really, a collapsed lung on an 18-year-old after one year? That’s mind-boggling,” Zuckerman said. “He didn’t have the symptoms that might have warned him that something was wrong — until something was really terribly wrong.”
The big problem she sees with Juul and other e-cigarettes and vapes: “We don’t know yet what the symptoms might be,” Zuckerman said.
It took doctors years to fully understand all of the risks associated with smoking cigarettes, including cancer, Zuckerman said. When it comes to vaping, it is too early on for doctors to know all the potential long-term health consequences. However, there is growing evidence of short-term risks and lung damage, according to Zuckerman.
“Lung damage is what we’re most focused on right now, but there’s so much more going on,” she said. “There are chemicals in Juul and e-cigs and we’re not exactly sure what the impact is going to be because we haven’t seen it before.”
[…]
While there are many unanswered questions about vaping that may be revealed over time, one thing is starting to become clear to Zuckerman: “It seems some kids are having very measurable damage in a very short period of time than what we’ve seen from [cigarette] smoke.”
Juul’s popularity with teens is a particular concern because the rash of lung problems appears to be affecting young people more than any other age group. “The same amount of vaping for a child that weighs, say, 100 pounds, is a bigger issue than for somebody who weighs 200 pounds,” Zuckerman said.
See the original story here.
John Fauber, Milwaukee Journal Sentinel: August 8, 2019.
In 2011, a group of influential dermatologists, most of whom had financial ties to drug companies, issued a set of national guidelines for treating psoriasis.
It said a class of immune-suppressing drugs could be used to clear up mild skin issues before weddings or other special events.
The problem: The recommendation went against the approved uses for the drugs, which carry stringent safety warnings from the U.S. Food and Drug Administration.
In 2012, AbbVie created a “Nurse Ambassador” program that paid nurses around the country to make home visits to patients who had been prescribed Humira, its rheumatoid arthritis and psoriasis drug.
The wrinkle: The nurses were instructed not to mention the risks of the drug, which include potentially deadly infections, according to a lawsuit filed by California regulators.
In 2014, Pfizer paid for a study of its rheumatoid arthritis drug Xeljanz — one authored by 12 experts, all with financial ties to the company. Xeljanz came out on top.
The twist: It was not compared to the treatment experts consider the most effective.
All three efforts were part of a massive drug company push to boost the sale of expensive, immune-suppressing drugs to treat autoimmune conditions such as psoriasis and rheumatoid arthritis.
The drugs, many of which are biological medicines, called biologics, were introduced two decades ago and have hit $45 billion in sales, despite escalating prices and mounting reports of serious side effects.
“There are a lot of different playbooks on drugs,” said Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research, a public health advocacy group. “The industry knows how to sell a product.”
AbbVie’s nurse program is the focus of an insurance fraud lawsuit filed last year by the California Department of Insurance. It alleges the company paid kickbacks to doctors to prescribe the drug and sent the nurses into homes “to keep patients on a dangerous drug at any cost.”
The lawsuit, which claims more than $1.2 billion in insurance fraud, alleges the nurses were trained to hide Humira’s serious cancer and infection risks — allegations AbbVie denies.
The nurse program offers a unique spin on what past Milwaukee Journal Sentinel investigations have found to be a pattern of drug company money touching every step of the process.
Upbeat TV commercials and magazine ads that tout the benefits of the drugs.
Treatment guidelines that call for doctors to prescribe them — written by doctors with financial ties to drug companies.
Favorable studies underwritten by drug companies — often conducted by researchers who double as speakers and consultants to the companies.
Biologic drugs are cultured from animal cells and introduced by injection or IV.
The drugs are often effective and can lead to significant improvement in symptoms, even remission. But they also leave patients susceptible to a growing number of infections and other serious side effects.
Of the 21 biologic drugs that have won FDA approval, 13 — 62% — have received the agency’s most stringent warning, known as a “black box.” In the majority of those, the warnings were added when serious risks and side effects began showing up after the drugs were on the market.
Earlier this year, a Milwaukee Journal Sentinel investigation found more than 1 million “adverse events” were reported to the FDA in people using the drugs since 2004, including nearly 500,000 that were deemed serious.
There were 34,000 reported deaths.
While the FDA database has limitations, including a lack of verification of the reports and the possibility that other drugs could also have been used, it is the largest publicly available data set of reactions associated with prescription drugs.
If anything, experts say, it undercounts the potentially dangerous incidents.
Zuckerman, the head of the public health advocacy group, said part of the drug company strategy is to get the FDA to approve more and more products — or to get existing drugs approved to treat more and more conditions.
That creates a confused marketplace.
“The doctors are left with 20 different products and no idea which one is best for which patient,” she said.
Led by top-selling Humira, biologic drugs have become some of the biggest moneymakers for the U.S. pharmaceutical industry.
Prescriptions for them were on pace to exceed more than 6 million in 2018, up from about 4 million in 2013, according to data from the pharmaceutical market research firm IQVIA. That represents a 50% increase.
Humira prescriptions were set to top 3 million, an increase of more than 60%.
Meanwhile, biologic drugs were expected to tally $45 billion in sales, with Humira on pace to hit $18 billion alone — an increase of more than 150% since 2013.
The list price on the drugs can exceed $40,000 a year, though rebates and discounts can reduce the amount paid by insurance companies and individuals.
There are now more than 20 biologic drugs on the market, in addition to other, traditional treatments for the conditions.
Yet prices seem to defy the laws of supply and demand.
A February 2019 paper in the journal JAMA Internal Medicine looked at three of the most popular biologic drugs in a class known as tumor necrosis factor inhibitors: Humira, Enbrel and Remicade.
Before 2009, they were the only such drugs approved to treat rheumatoid arthritis.
In the years that followed, the FDA approved three more drugs — increasing competition. The study authors expected costs would still rise 34% from 2009 to 2016, due to inflation and other factors. Instead, costs went up 144%.
[…]
In September 2018, the California insurance commissioner’s office laid out its case of financial impropriety against AbbVie, providing a window into the push to boost sales of Humira.
A similar lawsuit was filed in federal court in Illinois.
That lawsuit alleges AbbVie officials “bragged at national sales meetings about how the Ambassador Program resurrected the otherwise plateauing sales of Humira and attributed a sharp and specific rise in sales directly to the Ambassador Program.”
Both cases are pending. AbbVie denies wrongdoing.
[…]
The California lawsuit alleges the program began as a pilot effort in 2012, developed a presence in California in 2013 and soon became “wildly successful in this state and others.”
Through the program, doctors allegedly got kickbacks in the form of cash, meals, drinks, gifts, trips, even patient referrals.
One court document indicates the national program reached 179,000 patients.
“Kickbacks and more sophisticated schemes, like those alleged in the AbbVie case, are significant drivers in the out-of-control cost of prescription drugs that harm consumers,” California Insurance Commissioner Ricardo Lara said in a statement to the Journal Sentinel.
His office estimates private insurers in California alone paid out $1.2 billion in Humira claims from 2013 to 2018, making it potentially the largest insurance fraud case in the department’s history.
[…]
In 2018, Humira topped all drugs for ad spending, at $483 million, according to data from the firm Kantar Media, which tracks cross-media ad spending.
Xeljanz, a non-biologic that competes in the same market, was third at $256 million. Cosentyx, a biologic, was eighth at $180 million.
The totals include all ad spending, aside from social media, but TV commercials are clearly at the center of marketing efforts — particularly on cable news networks.
During a five-day span in mid-March, a total of 21 commercials for autoimmune system drugs — most of them biologics — were aired during cable news shows on CNN, Fox and MSNBC between 6 and 9 p.m., according to a Journal Sentinel analysis.
[…]
Rita Redberg, editor of the journal JAMA Internal Medicine, said she is struck by how many of the drugs are advertised on TV.
“It is clear (the drugs) are not selling on the merits alone, otherwise they wouldn’t need all the advertising,” said Redberg, a professor of medicine at the University of California, San Francisco.
Doctors frequently turn to treatment guidelines when it comes to determining how to care for patients. The guidelines, which serve as national standards for treating various diseases, often are used by front-line doctors who see patients and write prescriptions.
They are frequently issued by medical societies and related groups.
Where do the groups get their money?
Often from companies marketing the drugs.
[…]
Consider the 2011 guidelines for treating psoriasis and psoriatic arthritis issued by the American Academy of Dermatology.
Those guidelines said that if a person with a milder case of the disease has an important upcoming event, such as a wedding or graduation, it is OK to use biologic and other drugs.
However, the FDA has only approved biologic drugs for more serious cases, what is known as moderate to severe psoriasis.
The guideline-writing committee was made up of 15 experts, 12 of whom — including the chairman — had financial ties to companies that make biologic drugs.
At the time the guidelines were issued, committee chairman Alan Menter disclosed he received money from three companies that make biologic drugs for psoriasis, but did not list the amounts.
A check of the federal government’s Open Payments database showed that in 2013 he received about $90,000 from those companies. He continued to work with the companies, receiving more than $300,000 between 2014 and 2017.
[…]
Meanwhile, the American Academy of Dermatology has received millions of dollars in funding in recent years from companies that manufacture biologic drugs, based on giving levels the group lists on its website and other records. AbbVie, the maker of Humira, alone gave more than $2 million in grants and donations to the academy between 2013 and 2017.
[…]
Financial conflicts were also at play in 2015 treatment guidelines for rheumatoid arthritis from the American College of Rheumatology.
Rheumatoid arthritis causes inflammation, leading to swelling, pain, stiffness and potential damage to the joints. The condition affects more than 1 million Americans.
Experts generally agree that the best first-line treatment for the condition is the generic drug methotrexate, which is normally is taken by mouth. If that fails, a biologic can be added.
But there are other options, such as adding two generic and less expensive non-biologic drugs — what is known as “triple therapy.” A 2013 paper in the New England Journal of Medicine showed that approach to be just as effective as adding the biologic Enbrel.
The effectiveness may be equal, but there is a dramatic difference in cost.
“Triple therapy” costs less than $4,000 a year, while taking a biologic drug costs about $43,000, according to an analysis provided to the Journal Sentinel by Alvaro San-Juan-Rodriguez, a research fellow at the University of Pittsburgh School of Pharmacy.
When the American College of Rheumatology issued its treatment guidelines in 2015, it did not factor in the difference in cost, which would have put biologics at a disadvantage.
The guidelines simply said either approach could be used.
Nine of the 26 members of the committee had financial relationships with companies that either made or were developing biologic drugs at the time, a Journal Sentinel analysis found.
[…]
The influence of drug company money is increasing among experts who author papers about drugs used to treat rheumatoid arthritis, according to a May 2019 paper in the journal Rheumatology.
The paper found conflicts of interest among authors in 54% of studies in 2002 and 2003. That increased to 65% for the second period examined, 2010 and 2011.
A Journal Sentinel examination of rheumatoid arthritis studies and financial disclosure forms found an especially conflicted 2014 study of the Pfizer drug Xeljanz.
All 12 authors had financial ties to the company, including eight who were employed by Pfizer, which funded the study.
What’s more, the study compared Xeljanz to the drug methotrexate alone — not the more effective treatment of methotrexate plus a low-dose steroid. The study concluded Xeljanz was better.
Other studies of rheumatoid arthritis drugs have taken the same approach.
Pfizer spokesman Steven Danehy noted the study authors are recognized experts in the field and work with many pharmaceutical companies. He added: “Further, the New England Journal of Medicine works with an editorial team that employs rigorous editorial, peer and statistical processes to evaluate manuscripts for scientific accuracy.”
Critics question why Xeljanz was tested against a “second-best treatment” — and whether patients in the trial knew what they were getting.
“Comparing the new treatment to a treatment that we already know is not good enough proves nothing,” said John Kirwan, an emeritus professor of rheumatic diseases at the University of Bristol in the U.K.
“You can’t help thinking that the company designed their study this way just to make their new treatment look good.”
Read the original article here.
Michelle Llamas, DrugWatch: July 31, 2019 Update.
Consumers should always read drug labels to make sure they are taking a medication correctly and safely as well as to learn about possible side effects. Unfortunately, these labels can be challenging for the average person to digest.
If you struggle to make sense of the information on your drug labels, you are not alone.
“Several studies have shown that patients often have difficulty in reading and understanding medication labels, which may lead to medication errors such as taking the wrong medication or the wrong dose,” said Mireille Hobeika, who received her doctorate in pharmacy from the University of Saint Joseph in West Hartford, Connecticut.
Understanding drug labels is even more important for people with chronic illnesses and seniors. They have the greatest risk of medication errors or interactions because they tend to take multiple medications.
There are two kinds of drug labels: over-the counter drug labels — also called Drug Facts — and prescription drug labels, which include many pages of safety information, such as pharmacy information sheets, medication guides and prescribing information.
Before you start taking a new medication, review the drug label with your doctor and pharmacist and let them know of any health conditions you have and any medications and supplements you take.[…] Diana Zuckerman, president of the National Center for Health Research, recommends patients consider the following questions and tips when reading clinical trial data on drug labels.
If a drug has an FDA-approved medication guide, pharmacists are supposed to give it to patients with their prescription, but this doesn’t always happen. And not all drugs have them.
The FDA requires manufacturers to write medication guides in easy-to-understand language for patients. You can find these medication guides on the drug manufacturer’s website or on DailyMed.
The blood thinner Coumadin, also known under the generic name warfarin, has a medication guide. Similar to the Drug Facts on an OTC label, the medication guide tells patients the most important prescription drug information in simple language.
Side effect information on drug labels usually comes from clinical trial data collected before a manufacturer sells the drug. Sometimes the label will get an update based on side effect reports the FDA receives after the drug has been on the market. This information is called postmarketing data.
“If side effects are known, they should always be included on the label, but some side effects aren’t known until years after a product goes on the market,” Zuckerman said.
Drug manufactures can face lawsuits if they know about a side effect but fail to warn consumers and doctors.
“Back when I took Levaquin in 2006, there were no black box warnings on fluoroquinolones,” said Brummert, who suffered multiple ruptured tendons after taking the antibiotic. “The first warning came in 2008 for tendon ruptures, and that black box only stated that people over 60 were at risk. Adverse reactions I have suffered that are still not included in the warnings are autonomic and central nervous system dysfunction and neurodegenerative disorders.”
Brummert said she discovered the FDA had admitted to these side effects in a hidden document obtained through a Freedom of Information Act request.
If you have tried reading a drug label and don’t understand it, don’t be afraid to ask for help. Your health care provider and pharmacist are there to assist you.
“Before leaving the doctors’ office, patients should make sure they are well informed about the name of the drug and why they are taking it, the medical conditions this drug treats, how many times per day should they take it, how long will it take this drug to work, when should they stop taking it, are there any side effects that they should know about and any situations where they should not be taking the drug,” Hobeika said.
If you leave your health care provider’s office without the information you need to take your medicine safely and effectively, the pharmacy from where you pick up your medication can help. Your pharmacist can answer questions about OTC and prescription medications.Hobeika recommends having all prescriptions filled at the same pharmacy, so the pharmacist has a record of them. She also suggests doing the following before you leave the pharmacy:
Read the full article here.
Michelle Stacey, Allure: July 29, 2019.
Candyce Kirbyson wanted a bit more. At 105 pounds, she had A-cup breasts. So at 32, the Seattle-area mom decided to get implants. But she got a lot more. A laundry list of ailments, in fact. Hives and muscle weakness. Numbness and tingling in her arms and legs. Insomnia and chronic sinusitis. At various points in Kirbyson’s 14-year slog through doctor’s offices, MRIs, and emergency-room visits, it was suggested (among many other potential diagnoses) that she had “mold toxicity,” sometimes known as “sick-building syndrome.”
Kirbyson wondered if it had to do with her new office. “I was on and off antibiotics that would work for a while, and then my hives and inflammation would come back,” she says. “I sometimes felt like I was getting early Alzheimer’s, like my brain wasn’t working. I tried integrative medicine, functional medicine, ENTs. Nobody could figure out what was going on, and doctors said it was all in my head. I felt like I was dying.”
Never once did Kirbyson suspect the implants as the source of her sickness since she didn’t have pain in her breasts and not one doctor had ever raised the possibility.
Then late last year, she read an article that led her to a Facebook group that described similar symptoms. “I started crying my eyes out, because everything I was reading was what had happened to me,” she says. Kirbyson consulted a local plastic surgeon who was mentioned in the group and had her implants removed in January.
Slowly, her symptoms are diminishing. “My energy is back, my brain fog is lifting, the tingling and hives are happening less,” she says. “I’m 500 percent sure that my whole system broke after I got implants.”
An alarming conclusion, particularly since breast augmentation is the most popular plastic surgery. There were almost 314,000 procedures in the U.S. in 2018, up 4 percent from the previous year. In a 2011 report, the Food and Drug Administration estimated that between 5 and 10 million women worldwide have breast implants. Admittedly, fears about potential dangers have surrounded implants since their inception in 1961. But past concerns were that they would rupture and leak.
The new fear factor: Could simply letting these things exist in your body be ruinous? Claims like Kirbyson’s — that breast implants have triggered inexplicable chronic illness — are growing, and new reports show a direct line from implants to a rare lymphoma. In March, the FDA held a public advisory committee meeting on breast implants to discuss these issues. Sides were taken, and tensions ran high.
One of the speakers, Diana Zuckerman, the president of the National Center for Health Research, who has been a voice in the debate for decades, says: “I was struck by how often the answer to a question was ‘We don’t know.’ We don’t know which implants are better or worse, or how often people get sick. Women deserve to know what their odds are of getting sick because of their breast implants, and we can’t answer that question.”
Doctors and the FDA concede that there is still much to learn, says Grant Stevens, the president of the American Society for Aesthetic Plastic Surgery (ASAPS) and a clinical professor of plastic surgery at the Keck School of Medicine of USC. But after 35 years of performing breast implants on more than 10,000 patients, he’s convinced that the vast majority have few problems with the devices.
Women suffering from what they call breast implant illness (BII) beg to differ. Though not a disease, BII has recently gained credibility. So much so that the FDA has incorporated the patient-coined term into its website among cautions about implants, citing “systemic symptoms” as one potential risk, although “what causes them are poorly understood.”
In the run-up to its March meeting, the FDA listed examples of the top reported BII markers: fatigue, brain fog, rash, joint pain, and memory loss (amid an exhaustive 87-item list of other possible issues, including “ear ringing” and “throat-clearing”).
“BII is not a diagnosis,” says Stevens. “It’s a collection of symptoms — about 22 of which I have myself at any given time. [But] I’ve looked into the eyes of women who say they’re going through it, and I know they’re not making it up. They’ve seen a bunch of doctors; they’re frustrated; they’re scared.”
There have been no formal studies on BII to mollify those fears. (The first of its kind is starting now, funded by the Aesthetic Surgery Education and Research Foundation, according to Stevens.) It’s difficult to track symptoms that are so subjective and wide-ranging, and Laurie A. Casas, the former president of ASAPS’s Aesthetic Surgery Education and Research Foundation and a clinical professor of plastic surgery at the University of Chicago Medicine, says many manufacturers have “had trouble getting” follow-up reports on patients who use their implants — an FDA requirement.
In March, the agency issued warning letters to two companies, Mentor and Sientra, for falling far short. In a statement to Allure, Mentor admits they “continue to encounter challenges,” due to the low percentage of U.S. patients who use their textured implants. Sientra told us that many of its patients have family and work obligations that preclude them from follow-ups, but says it’s committed to helping bridge that gap by compensating patients and doctors.
“I think some companies did a lousy job,” says New Jersey–based plastic surgeon Caroline Glicksman. “You tend not to hear from patients who are doing fine. These manufacturers should incentivize women who take time and spend money to show up for follow-ups every year.” One company that did that, Ideal, was able to track nearly 95 percent of its patients for five years by offering a balloon payment at the end of the study, potentially granting each woman $5,000 to $8,000.
The recent establishment of several breast implant “registries” could also help to assess long-term safety. “Ideally, we want to track every implant in every patient over the lifetime of the implant,” says Casas. “These studies should have a control group of women of the same age that do not have implants. That way we can understand the incidence of these symptoms in women of the same age who have and do not have implants.”
That raises the question: Could it be that breast implants aren’t for everyone? Many doctors are intrigued by the potential of using genetic tests to determine whether someone might have inflammatory or allergic “markers” that would indicate they’re a bad fit for the devices, says Casas. That’s a possibility the FDA is now entertaining, saying in a statement: “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. They develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”
That small number of patients is radicalized. The Breast Implant Illness and Healing Facebook group, for one, has grown from a few hundred members to more than 70,000 in the past three years. Its message — your breast implants are making you sick — is powerful. But that power can be a double-edged sword, says Nashville-based plastic surgeon Melinda Haws. “Many women have turned to social media for support and information when their doctors were unsympathetic,” she says. “Unfortunately, the support groups, in many cases, have become more trusted than the plastic surgeons. If I’ve got a pain in my knee, I can search the Internet for the cause. But I still have to see an orthopedic surgeon.”
BII’s symptoms can make many patients feel helpless and unnecessarily guilty, since it’s an elective surgery. “Many women have described to me the negative impacts on their family and their jobs that they believe have come from this procedure,” says Haws, adding that such worries can compound and worsen insomnia and anxiety.
For patients like Kirbyson, advice from the BII group was transformational. However, for Celeste Greene*, it presented a red herring. Greene got her first implants at age 21. They were saline and lasted six good years, until they began to feel hard and she traded them for silicone implants. She soon developed some symptoms similar to Kirbyson’s, went through full-panel tests with no conclusive diagnosis, and three years later, found solace and enlightenment in the same Facebook group.
Within about nine months of finding the group, she had her implants removed. As she recovered, Greene felt markedly better. Fast-forward a few months, and all of her symptoms returned. It took another year, a divorce, and finding out that her estrogen was abnormally low (“My endocrinologist said it was like that of a 60-year-old woman!”) for Greene, now 36, to get a complete picture. She is now positive that job stress, studying for board exams to keep that job, an abusive marriage, and hormone irregularities were collectively the “perfect storm” that caused her malaise. “It was an expensive lesson.”
[…]
See the original story here.
Denise Grady, The New York Times: July 24, 2019.
Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday.
The F.D.A. decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year.
Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.
[…]
F.D.A. officials said they were continuing to monitor the incidence of lymphoma linked to other types of implants and would take action against them if needed.
They also said they were considering changes to the labeling of breast implants, like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.
The contents of the implant, silicone or saline, are not a factor in the lymphoma. The covering or shell of the implant, which can be either smooth or textured, is the key. Textured implants, which have a slightly roughened surface that adheres to tissue and helps hold the device in place, have been singled out as the cause of the lymphoma.
Why the texturing leads to cancer in some patients is not known. Some people may be genetically predisposed to have an inflammatory reaction to the texturing that can gradually lead to cancer, Dr. Clemens, the plastic surgeon, said. Some researchers also suspect that bacteria trapped in crevices in the roughened surface might somehow lead to the lymphoma.
Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products.
Allergan’s textured implants account for only about 5 percent of the implants used in the United States, but have been much more common in Europe, where they have already been recalled by many countries. Worldwide, 38 countries have banned textured implants, Dr. Clemens said.
Allergan said on Wednesday that it was halting sales of the textured implants worldwide.
“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” said Diana Zuckerman, president of the National Center for Health Research, who has studied implants.
She added that the recall would reduce the risk but not eliminate it, because some women with other types of implants also had the lymphoma.
See the full story here.
Sasha Chavkin, IJIC: July 24, 2019.
Allergan will recall its Biocell textured breast implants worldwide after United States health authorities requested that it remove them from the market due to their association with a rare cancer of the immune system.
The announcement, which reflects the most sweeping recognition to date of the serious health risks associated with breast implants, comes after the U.S. Food and Drug Administration obtained new data showing that Allergan implants were linked to most known cases of the cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
“Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Amy Abernethy, in a statement issued by the agency.
The company said the recalled implants, both saline and silicone, would no longer be distributed or sold in any market where they are currently available.
[…]
President of the National Center for Health Research Diana Zuckerman, who has called for stricter oversight of breast implants, said Allergan’s recall was a step in the right direction but did not eliminate the risks of BIA-ALCL.
“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” Zuckerman said.
“This recall will reduce that risk but it won’t eliminate it, because the FDA has stated that not all women with BIA-ALCL had these specific types of implants.”
In its press conference, the FDA said that it was considering additional measures to protect patient safety.
The agency said it would soon announce updated labeling standards for breast implants, and that these might include a black box safety warning, which is reserved for products that pose the most serious health risks.
The FDA also said it might require a patient checklist, a document that briefly states the key health risks from breast implants which patients would sign before undergoing surgery. The agency is not recommending that women who currently have Allergan Biocell implants get their implants removed, unless they experience signs or symptoms of BIA-ALCL.
Read the full story here.
Laurie McGinley, Washington Post: July 24, 2019.
Allergan announced a worldwide recall of textured breast implants Wednesday after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them off the U.S. market.
The Dublin-based company said it is recalling Biocell textured breast implants and tissue expanders from all markets in which they are sold. The devices had already been banned or recalled in several countries.
The FDA said the new data shows that 573 cases worldwide have linked the rare cancer to the implants since the agency began tracking the issue in 2011. The vast majority of those cases involve Allergan products. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Of those fatalities, authorities identified the implant manufacturer in 13 cases — and it was Allergan in all but one.
In February, the last time the FDA had updated its numbers on implant-associated illness, it reported 457 cases and nine deaths worldwide.
The agency said Wednesday that the latest data indicates the risk of such disease is six times greater with Allergan Biocell textured implants than with other types of textured implants sold in the United States.
The FDA’s new stance against the Biocell product is a reversal of its posture a few months ago, when it said there was insufficient evidence to try to remove the devices from the market.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said on a news call the agency changed its position partly after seeing the sharp increase in reported deaths.
Allergan pulled the products off the European market last year. Canada banned them in May after finding an increased risk of cancer.
[…]
Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization, welcomed the FDA’s decision to press Allergan to recall the implants. “We are very glad they have done it,” she said. “I think they could have done it months ago and I hope a lot of women have not been getting these implants in the meantime.”
The FDA said that in most cases, the rare lymphoma linked to the implants is found in scar tissue and fluid near the devices, but that sometimes it can spread throughout the body. The condition can be life-threatening if it isn’t diagnosed and treated promptly, the agency said. Most patients are treated successfully by surgery to remove the implant and scar tissue but some may require chemotherapy or radiation.
Scientists are not sure why certain textured implants might be linked to the rare cancer. “We don’t know what it is that might increase the risk,” said Binita Ashar, director of the FDA’s office of surgical and infection control devices.
The agency said its data on the rising incidence of illnesses and deaths related to the implants came from medical device reports and searches of medical literature.
See the full article here.
Matthew Perrone, AP for ABC Action News; July 24, 2019
WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.
The FDA is not recommending women with the implants have them removed if they are not experiencing problems.
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WASHINGTON (AP) — Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface account for a disproportionate share of rare lymphoma cases. The move follows similar action in France, Australia and Canada.
The FDA is not recommending women with the implants have them removed if they are not experiencing problems.
[…]
The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.
The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants.
There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3,000 patients to 1 in 30,000 patients.
Diana Zuckerman, a researcher who has studied breast implant safety, called the removal of the devices inevitable.
“Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” Zuckerman said in an email.
Read the full story here.
Sydney Lupkin and Christina Jewett, KHN; May 30, 2019
The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018.
The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body.
When the FDA initially announced the meeting in March, it acknowledged in a letter to doctorsthat “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.
“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing legal case.
Surgical staplers have a unique ability to harm patients if they malfunction. Often used in minimally invasive surgeries, they are meant to both cut tissue and vessels and then quickly seal them. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.
The nonpublic reports were sent to the FDA as “alternative summary” reports, the topic of a recent Kaiser Health News investigation that focused on the agency accepting millions of hidden reports related to medical devices — including for surgical staplers.
The agency had previously acknowledged that in 2016, even as it posted fewer than 100 stapler-related injuries in a public database called MAUDE, it accepted nearly 10,000 reports into its little-known internal alternative summary reporting database. (The data in the FDA’s executive summary contains reports for staplers and staples, which experts have said were just different names for the same problem.)
Tuschman said he was stunned that there were more hidden reports than public ones in the executive summary. “The first question should be ‘Why?’ Why would they have the right to submit to a hidden database?”
Leading surgical stapler makers include divisions of Medtronic and Johnson & Johnson. Medtronic has said the FDA granted it exemptions for stapler-related malfunctions; Johnson & Johnson said it has not. (Ethicon is the name of its subsidiary medical devices company.)
On Thursday, the advisory panel recommended switching surgical staplers to a higher-risk classification with additional safety requirements, according to meeting attendee Jack Mitchell, director of health policy for the nonprofit National Center for Health Research. FDA spokeswoman Stephanie Caccomo declined to confirm this, citing a media office policy against telling reporters what happens at advisory committee meetings, which are open to the public.
“Every surgeon that I have ever worked with has had stapler failures,” said Dr. Doug Kwazneski, a Michigan surgeon who authored a survey in 2013 about “unacknowledged” stapler problems after searching the FDA’s public database of device incidents and coming up empty-handed.
“Going into something without data is dangerous,” Kwazneski said. “If the information exists, we should have access to it.”
More than 400 deaths have been reported since 2011 in the FDA’s public MAUDE database; fatalities can’t be reported to the alternative summary reporting database. Deaths were associated with Ethicon and Covidien products.
In recent communications about stapler safety to doctors, the FDA has advised against using the staplers on large blood vessels.
Kwazneski said surgical staplers are a time-saving tool, which lessens the risk of anesthesia complications during surgery, for example. But it’s important for physicians to remember they can fail.
Diana Zuckerman, president of the National Center for Health Research, said that alternative summary reports are “a well-kept secret” and that any reports related to their existence were “done in a way that was not understood as a repository for hundreds of thousands of serious adverse event reports.” […]
See the original story here.
