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Sunday, July 21, 2019

Biden’s health care gaffe

Joe Biden performs one political belly flop after another. This week the former vice president rolled out his health care plan, which mainly featured a hearty embrace of ObamaCare along with, in a nod to the times we live in, a sizable dollop of government meddling.
The homage to the signature achievement of his White House years – which he once called “a big f–king deal” – was meant to distinguish him from his many rivals calling for an end to the Affordable Care Act [ACA] and also to private insurance, a proposition that is not popular with most Americans. His defense of ObamaCare was also meant to tie him ever tighter to “my buddy Barack,” as Biden has called him.
Unhappily for Biden, that tie became a noose when, in promoting his plan, he echoed the signature lie told by President Obama, claiming that, “If you like your health care plan, your employer-based plan, you can keep it.” That falsehood, repeated over and over by Biden’s boss as he attempted to sell the public on his health care program, became emblematic of the dishonest promises made by the prior administration, and ultimately undermined faith in the ACA, and in President Obama.
Obama knew his plan contained no such assurance; he knew the claim was untrue. Even the liberal site Politifact labeled it “the lie of the year.”
It is unimaginable that Biden or his team did not recognize the danger of invoking that promise.
It is especially unimaginable since his health care proposal is one of the few detailed policy blueprints that Biden has bothered to release. As his campaign has strolled forward, he has released only the sketchiest of climate and student loan plans, and virtually nothing on housing, trade, entitlements, and numerous other issues. His healthcare plan, consequently, looms large for the Biden campaign.
Not only is health care critical to Biden; it also figures to play a central role in the 2020 election. Democrats won big on the issue in 2018, reminding voters of repeated Republican efforts to abolish ObamaCare and their embarrassing failure to provide an alternative. It remains a potent weapon against the GOP, especially as it remains the number one issue on the minds of voters.
It is also divisive among Democrats. Ironically, the issue that brought them together successfully in 2018 is the issue likely to tear them apart in 2020.
Against that backdrop, Biden’s miscue is even more consequential. Only recently has the former veep mixed it up with his fellow Democrats; for months he virtually ignored the other 23 or so men and women vying for the nomination. On health care he has carved out his own space, pointedly criticizing “Medicare for All,” which is being advocated by progressives such as Sen. Bernie Sanders (I-Vt.), Elizabeth Warren (D-Mass.) and Kamala Harris (D-Calif.).
On the campaign trail recently, Biden talked up ObamaCare and criticized those who would tear it down in favor of Medicare for All, saying “I don’t know why we’d get rid of what in fact is working and move to something totally new.” Biden touted his cheaper and more expedient approach, saying his plan “doesn’t cost $3 trillion, and it can be done quickly.”
Biden’s plan, his team says, would cost $750 billion over ten years.
He followed up by noting that Sanders had admitted that implementing Medicare for All would mean higher taxes on the middle class and the end to private insurance—both features that will be especially unpopular with the blue-collar voters that Democrats lost in 2016 and that they will need to win back in 2020.
In swing states such as Pennsylvania, Ohio and Michigan, unions have fought hard to win generous health care packages in recent years from companies unwilling or unable to increase wages. Those union members are not keen to see those benefits traded in for an uncertain government-run program.
And, they sure don’t want higher taxes.
Biden, to be sure, bowed to the current leftward tilt of his party by proposing to add a public option available to everyone and by vowing to rein in Big Pharma pricing, in part by repealing the law that prohibits Medicare from negotiating lower prices with drug companies. But the core of his plan is incremental fixes to ObamaCare, including reintroducing the unpopular individual mandate.
On health care, and on other topics as well, Biden presents himself as the seasoned and pragmatic moderate, the candidate best able to beat Donald Trump. He will hope to scare voters by warning that Trump wants to eviscerate their health care and do away with popular provisions like protecting pre-existing conditions. Other Democrats have sounded similar alarms, but have also vowed to throw the existing system under the bus.
Biden should be a winner here, appealing to a population worried about rising health care costs but, in the main, content with the coverage they have. With all the concerns raised about our existing medical and insurance offerings, it is startling that Gallup finds more than three-quarters of Americans “have consistently rated the quality of their healthcare positively” over the past 18 years while roughly two-thirds have said their coverage is excellent or good over the same period.
Biden is running against the progressive tide, and many moderate Democrats, appalled by the leftward lurch of their party, are ready to support him. But if he can’t avoid obvious bloopers that undermine his message, he will never make it to the finish line.

How Will 3D Printing Be Used in Healthcare?

3D printing is a rapidly growing industry that has the potential to impact many markets, including healthcare. From biostructures comprised of cells to assistive devices and surgical tools, 3D printing has a plethora of uses and is only just starting to leave its mark in medicine. Read on for some of the top uses of this exciting technology in healthcare as well as corresponding news stories.

Forming Cornea Tissue to Combat Blindness

Pandorum Technologies, an Indian bioprinting startup, has recently used 3D printed cornea tissue to facilitate the healing of wounds in the eye. Using a novel hydrogel, the company’s bioprinted tissue promotes scarless healing of wounds in the cornea through a regenerative process. Corneal opacities were estimated by the World Health Organization (WHO) to account for 7 percent of all blindness in 2010, making the condition among the most common causes of blindness. Additionally, 20 percent of all childhood blindness is estimated to be caused by corneal defects. With 12 million people waiting for corneal transplants worldwide, emphasis has been put on 3D printing as an alternative source of replacement corneas. Read more

Replicating Intricate Structure’s in Human Organs

A recent innovation in 3D printing allowed bioengineers to recreate the intricate human vascular systems, marking a breakthrough in bioprinting organs. This work, featured on the cover of the May 3 edition of Science, involved a hydrogen model of the lung’s oxygen exchanging sacs known as alveoli. This work was led by Jordan Miller, a bioengineer at Rice University, and Kelly Stevens of the University of Washington, and included work collaborators at Rice, UW, Duke University, Rowan University, and a Massachusetts design firm known as Nervous System.

“One of the biggest road blocks to generating functional tissue replacements has been our inability to print the complex vasculature that can supply nutrients to densely populated tissues,” explained Miller. “Further, our organs actually contain independent vascular networks — like the airways and blood vessels of the lung or the bile ducts and blood vessels in the liver. These interpenetrating networks are physically and biochemically entangled, and the architecture itself is intimately related to tissue function. Ours is the first bioprinting technology that addresses the challenge of multivascularization in a direct and comprehensive way.” Read more

Aspect Biosystems Using 3D Printing in $2.2M Cancer Research Project

Aspect Biosystems, a 3D printing company based in Canada, was recently selected to carry out a $2.2 million project developing cancer treatments. The company’s microfluidic 3D bioprinting platform will be utilized in this project to create physiological, high-throughput tissues to be used in the screening process for immunotherapy treatments. These bioprinted tissues will hold utility in testing therapeutics designed to target hard-to-treat malignancies like triple negative breast cancer. This work will involve collaboration from pharma giants Merck and GSK, as well as McGill University’s Goodman Cancer Research Centre in Quebec.
The Goodman team, led by Morag Park, will be working with Aspect Biosystems to create tumors from breast cancer patients’ cells. Aspect Biosystems’ 3D printing expertise will be used to generate tissues that contain these cells, ultimately forming a model that can be used to test new drugs. Not only will these bioprinted structures evaluate the efficacy of such treatments, but they will be able to predict a patient’s response to the treatment as well. Read more

Surgically Treating Bone Fractures

Researchers from the Shijiazhuang Third Hospital in China have recently used 3D printing technology in treating rib fractures of five different patients. Surgical intervention has become an accepted treatment for multiple rib fractures and 3D printing offers an effective means of creating accurate models to prepare surgeons for the operation. This work was recently published in the Journal of Cardiothoracic Surgery.
Rib fractures account for 55-80% of all chest injuries, and are typically treated with local compression via bandages, rib traction, mechanical ventilation and other techniques. Surgical treatment is becoming accepted by more and more doctors; however, issues in this treatment of rib fracture present when the bone is extensively fragmented. This makes it particularly challenging for the surgeon to put the pieces together and decide where to make incisions.
Micron Dental@microndental
 : China: Researchers Improve Rib Fracture Surgeries with 3D Printing … In ‘Analysis of the advantages of 3D printing in the surgical treatment of multiple rib fractures: 5 cases report,’ Chinese researchers from Shijiazhuang Third Hospital http://bit.ly/2RyXSzC 

China: Researchers Improve Rib Fracture Surgeries with 3D Printing – 3DPrint.com | The Voice of 3D…

In ‘Analysis of the advantages of 3D printing in the surgical treatment of multiple rib fractures: 5 cases report,’ Chinese researchers from Shijiazhuang Third Hospital explore better ways to treat…
3dprint.com
3D printing can alleviate this issue by generating realistic models of the bone fracture that surgeons can use to pre-shape rib locking plates before the operation. These 3D printed models are created using thin-layer CT scans of patients before the operation. Read more

3D Printed Robotics in Knee Surgery

Miniature surgical robots that are unique to the individual patient’s anatomy are being created by researchers from the Australian Centre for Robotic Vision. At the head of this project is Andrew Razjigaev, who first created a snake-like robot prototype to aid in knee arthroscopy last November. Razjigaev now plans to create multiple SnakeBots that attach to a RAVEN II surgical robotic platform, working together to enhance operations. These devices are 3D printed at a low cost to fit the specific dimensions inside a patient’s knee.
The computational design algorithm used in this project generates on-of-a-kind SnakeBots that are unique to each individual patient’s body. The chosen design is most suited to fit in and flexibly move around within the joint capsule. The SnakeBot allows the surgeon to see inside the knee as well as manipulate tools for the operation. The inexpensive, 3D printed device is disposable as well.
This robotic surgical system has the power to revolutionize scope-driven surgeries, according to Jonathan Roberts, Centre Chief Investigator of the Queensland University of Technology-based Medical and Healthcare Robotics Group, and Associate Investigator Ross Crawford. Crawford is also a practicing orthopedic surgeon; therefore, he is very familiar with arthroscopic operations of the knee. Read more

Anthem: NC employees may face costly choice in health-plan contract dispute

Go out of network with your health-care providers, or join your spouse’s or partner’s health insurance?
That could be an expensive choice – potentially as soon as Jan. 1 – for more than 727,000 of North Carolina’s state government employees and their dependents, as well as state government retirees who haven’t qualified for Medicare and their dependents.
The State Health Plan, or SHP, is the largest buyer of medical and pharmaceutical services in North Carolina, spending $3.2 billion in 2017.
In October 2018, N.C. Treasurer Dale Folwell began his attempt to move SHP to a government pricing model tied to Medicare reimbursement rates, which typically are lower than what hospitals currently receive for services.
Folwell’s proposal would allow SHP to begin paying about 61,000 providers based on a percentage above current Medicare rates, along with an additional and adjustable profit margin estimated at 82%.
Hospitals and providers were given a July 1 deadline to sign the Clear Pricing Projectcontract or be considered as out of network to SHP on Jan. 1, 2020. Folwell said Wednesday that 27,000 medical providers have signed the contract.
However, just three of the state’s 126 hospitals have done so. Cone Health of Greensboro said on July 1 that it would not sign the contract, saying it would cost the health-care system at least $26 million.
Frank Lester, a spokesman for the treasurer’s office, said it does not have track how many SHP participants have spouses on their insurance plan.
When asked about in-network options for SHP participants to go to Cone physicians and providers, Cone Health said it “encourages them to take advantage of other insurance options during the fall benefits enrollment period.”
“We are urging state employees to look at their spouse or partner’s plan come open enrollment,” Cone Health said.
Employers and health insurers negotiate rates that provide in-network discounts to individuals covered by an employer-based plan. An insurer can have different in-network groups, depending on the plans chosen by the employer.
Without the negotiated discount, out-of-network costs can be significantly higher for most medical procedures.
The Kaiser Family Foundation reported in a 2018 study that a small, but increasing, number of small and large employers are requiring employees to pay on average a $100 monthly surcharge for their spouse to stay on their insurance if the spouse’s employer offers coverage.
Other employers are lowering the value of the benefit coverage for a spouse or partner rather than apply a surcharge.
“Switching to spousal coverage is an option for any employed couple, but increasingly, private employers are requiring workers to pay more or all of the cost of adding family members,” said Mark Hall, a law and public-health professor at Wake Forest Universityin Winston-Salem.
“Therefore, this switch will often cost the couple more money” compared with each spouse or partner having separate coverage on their employer’s plan, Hall said.
Limbo could last for months
Among the state’s health-care systems, UNC Health Care appears to be the most active with its opposition to the contract.
That includes submitting a counterproposal to the contract to Democratic Gov. Roy Cooper and Republican legislative leaders.
The pressure to sign the contract or go out of network will increase – as likely will the rhetoric on both sides – as the early fall timeline approaches for SHP participants to choose which providers they want for 2020 coverage.
If the typical contract negotiations between private health insurers and hospitals are any indication, the out-of-network limbo could linger for months before an agreement is reached.
“More employers are thinking of ways to incentivize getting spouses off their employees’ health-insurance plan,” said Matthew Rae, the associate director of the Kaiser Family Foundation’s program on the Health Care Marketplace.
“It’s been a slow build among employers to control their health-insurance costs, since spousal health-insurance coverage tends to be more expensive to provide benefits than employees on their own,” Rae said.
He said that for some people, being out of network could be more expensive; for others, the monthly premium surcharge could make coverage cost-prohibitive.
“The spousal insurance coverage, obviously, isn’t an option for millions of single Americans,” Rae said.
“If an individual has insurance coverage through their employer and chose not to access it because of providers being out of network, they likely can’t go to the federal health-insurance exchange because they have an employer insurance option,” he said.
Cost control
A 2017 study by human-resources consultant Mercer found that just 10% of large employers do not provide coverage for spouses who have other coverage available.
Mercer found that the use of spousal surcharges rose from 12% in 2015 to 14% in 2017 for all large employers.
Health insurer Anthem said its 2018 International Foundation of Employee Benefitssurvey found that 20% of employers now either charge employees more to add a spouse to their health plan or exclude spouses entirely. That’s up from 16% in 2016.
“Some only charge or exclude spouses who have coverage available elsewhere, while others have blanket policies for all spouses,” Anthem determined.
“If you’re eyeing your health-care expenses and considering a new strategy for spouses, introducing a spousal surcharge could offer a workable compromise, allowing employees to share coverage with their partners without blowing a hole in your company’s budget,” Anthem said.
The insurer said spousal and partner surcharges tend to be used by employers to offset rising health-care costs.
“They still want to offer good medical coverage, but the expense pushes them to decrease the number of spouses signing up for coverage if they have other viable options,” Anthem said. “Sometimes, the charges are necessary in order to keep premium increases as low as possible.
“Some employers have responded by barring spouses from joining employee health plans, but doing so can come at its own cost, potentially alienating married members of your workforce,” it said.
The Kaiser foundation said that in 2018, 99% of large companies (more than 200 employees) and 97% of small companies (199 of fewer employees) offer health-insurance coverage to spouses.
By comparison, 45% of small companies and 47% of large companies offer coverage to opposite-sex and same-sex partners.
When it comes to large companies, just 32% offered coverage to opposite-sex and same-sex partners in 2008.
About 13% of companies said they would provide additional compensation or benefits to employees who enroll in a spouse’s health-insurance plan, while 16% provided additional compensation or benefits to employees if they did not sign up for employee health coverage.
About 2% of companies have reduced their contribution to spousal benefits.
Who has signed contract?
The state treasurer has the authority to decide on SHP reimbursement cuts.
House Bill 184, which would block Folwell’s initiative for at least a year in favor of a legislative study report, cleared the N.C. House by a 75-36 vote April 3. It has yet to be acted upon in the N.C. Senate since being sent to the Rules and Operations CommitteeApril 4. Senate leader Phil Berger, R-Rockingham, has signaled he has no desire to take up HB184.
Cone Health said in a statement that a projected $26 million in lower SHP reimbursement would “reduce, and in some cases eliminate, services we provide daily. Thereby, risking our ability to invest in the future.”
“Cone Health has no choice but to decline joining,” it said.
Cone Health also said that “if we accept this contract, other payers may push for similar terms.”
Wake Forest Baptist Medical Center said on July 1 that it would not comment on its contract stance.
Novant Health Inc.’s latest comment on July 1 included that “it is our understanding that State Health Plan members will have an opportunity to verify provider’s network status after July 1, and before their open enrollment (for 2020) begins on Sept. 29.”
The three hospitals to sign the contract are N.C. Specialty Hospital in Durham, Martin General Hospital in Williamston and Randolph Health in Asheboro. The contract is administered by Blue Cross and Blue Shield of North Carolina.
Folwell said Randolph Health’s decision to sign the contract was done in part to provide a more dependable revenue stream for a hospital that is pursuing an acquirer. Randolph negotiated with Cone for 15 months before talks ended in June 2018.
Dr. Wesley Burks, the chief executive of UNC Health Care and dean of its medical school, told SHP leadership on June 27 that the system “is not in a position” to sign the current contract.
“While we crafted our plan independently, we believe it achieves many of the principles Treasurer Folwell outlines,” Burks said. “We do not speak for other hospitals and providers in the community; however, as actively working in other segments, we believe these ideas will be broadly welcomed.”
“Over the next few weeks,” UNC Health Care said, “we are optimistic we will be able to discuss these alternatives in detail with the leadership of the SHP.
“We are confident we will be able to reach agreement in ample time to avoid any impact upon the provision of, or access to, care for state employees, retirees, and their dependents.”
Reactions
Folwell called the UNC Health Care counterproposal “a silly back-to-the-future strategy that was presented to the previous treasurer and State Health Plan administration over three years ago and was rejected because of its lack of transparency and no concrete, measurable savings to the plan.”
Berger said hospitals and providers “will only be out of contract if they fail to come to an agreement with the State Health Plan and the treasurer.”
“The State Health Plan has reimbursement contracts with providers that run until the end of 2019, so I am still hopeful they can come to a solution that does not result in state employees seeing a reduction in available providers,” he said.
Cooper’s office said on July 1 it was reviewing the UNC Health Care proposal, noting, “The office believes the state should halt the treasurer’s plan until hospitals across the state can collaborate and provide input to assure patients will get the care they need.”
Folwell said in response to the governor’s office that Cooper “has always been aligned with the billionaire nonprofits and against those who teach, protect, and serve.”

Mount Sinai Leaders Discuss Cancer Immunology at Aspen Ideas Festival

Improving the drug ecosystem and challenging the status quo in drug discovery, the promise of new cancer treatments, and helping pediatricians and parents learn how best to help children thrive were among the topics presented at Aspen Ideas Health and the Aspen Ideas Festival from June 20-29, 2019, in Aspen, Colorado. Presented by the Aspen Institute and The Atlantic, the festival is a unique forum for the exchange of ideas.
With prescription drugs costing Americans an estimated $460 billion a year, finding a viable long-term solution to curb the price of once-affordable medications is a top priority, according to Kenneth L. Davis, MD, President and Chief Executive Officer of Mount Sinai Health System. “We want to ensure that patent laws favor innovative drugs, not just brand-name drugs that have added patents to extend the terms of market exclusivity even if there’s no additional patient benefit,” said Dr. Davis.
As a scientist whose research led to the U.S. Food and Drug Administration (FDA)’s approval for the first four out of five drugs to treat Alzheimer’s disease thirty years ago, Dr. Davis said more needs to be done to incentivize companies to take the risk to develop breakthrough treatments. “Despite 35 failed drugs in Alzheimer’s disease, we have to keep trying. The new direction is to give drugs to people well before they develop symptoms of Alzheimer’s so we can see if we can stop the progression–to see how many people convert to Alzheimer’s disease and how many don’t–but this will be very expensive and we need to provide incentives.”
Dr. Davis also said that drug companies should develop drugs for chronic diseases, not necessarily those that will make the most money for the pharmaceutical industry. “We need to find new drugs to treat pain that are not addictive, and we need to treat insulin resistance in type 2 diabetes so that we can reverse the effects of downstream consequences in diabetes,” said Dr. Davis. “To me there is an implicit social contract between pharmaceutical companies and the American people to keep the prices of drugs down–especially since the science comes from the National Institutes of Health, which is supported from taxpayer dollars.”
Dennis S. Charney, MD, the Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, co-invented a patented method for treating patients with treatment-resistant depression, Spravato (esketamine) nasal spray, which was approved by the FDA in early 2019. “The question is how to make a transformative discovery and in the case of this discovery, it was a small group of researchers who met every week to share ideas,” said Dr. Charney. “We also created a collaborative relationship with a pharmaceutical company to bring forth a treatment for a devastating disorder that has a profound impact on people’s lives.” Dr. Charney also encouraged more novel and transformative research to be funded by the National Institutes of Health.
In a panel titled “Immune Power: New Directions in Cancer Treatment,” Mount Sinai cancer experts discussed the revolution in using immunotherapy to fight cancer. “What we have learned is to harness the immune system, our own immune system which was developed to fight viruses and bacteria to keep us free of infections, and now have it directed at tumors,” said Steven J. Burakoff, MD, the Lillian and Henry M. Stratton Professor of Cancer Medicine who served as Director of The Tisch Cancer Institute at the Icahn School of Medicine from 2007 to 2017. “This has resulted in the ability to develop drugs that unblock the immune system so it could be effective against the cancer with far fewer long-term toxic or side effects than chemotherapy.
“Checkpoint inhibitors are the drug that has been instrumental in blocking the checkpoint that stops the immune system from working–so the immune system is activated to fight the cancer,” said Fred Hirsch, MD, Executive Director of the Center for Thoracic Oncology in The Tisch Cancer Institute at Mount Sinai. “In fact, 25 to 30 percent of patients with lung cancer benefit from this drug, as well as 35 percent of patients with metastatic melanoma. Both cancers were lethal five years ago.”
Miriam Merad, MD, PhD, Mount Sinai Professor in Cancer Immunology and the Director of the Mount Sinai Human Immune Monitoring Center (HIMC), said there are still more targets to find drugs for. “Our goal at Mount Sinai is to identify othercheckpoints and find new drugs that are already approved for other indications that we can give patients, or develop new drugs that will unblock the checkpoint, in order to reactivate the immune system in cancer patients.”
Experts also discussed the challenges of cancers, like pancreatic and brain cancers, that have learned to put up a barrier or “scaffolding” to prevent the body’s immune cells from getting close to the cancer. “We are all working to find drugs that will be able to find a drug to break down that wall so the body could fight the cancer,” added Dr. Merad.
The Mount Sinai experts urged cancer patients to get a full genomic panel review of their cancer. “Twenty-five years ago, you would go to an oncologist that treats many cancers, but now everything is very specific,” said Dr. Burakoff. “It is very important to go to a tertiary care center where the subspecialty expert will look at the tumor, look at the type of mutations you have and that will help identify or define some of the treatments that will bring forward.”
In a panel titled “Reinventing the Pediatrician’s Visit,” Carrie Quinn, MD, a pediatrician and Executive Director of the Mount Sinai Parenting Center, noted, “As a pediatrician, you are confident in diagnosing diseases such as meningitis and pneumonia, but you are less equipped to focus on language delays, development concerns, and mental health issues. So there is a big gap in what you are trained to do, and what you do in practice. That gap is the main reason we established the Mount Sinai Parenting Center: realizing pediatricians were not armed with the specific knowledge that was needed.”
Working in collaboration with the Bezos Family Foundation, Dr. Quinn has been pulling the science of early childhood development together to find out what key developmental concepts could be shared with pediatricians as well as parents. “We formulated six development keystones, including attachment, self-regulation, and problem-solving, as well as developmental areas of literacy, and created environmental messaging to help parents in the hospital setting know what to do to help their child succeed.”
Mount Sinai Kravis Children’s Hospital has also created a pediatric residency training program to give clinicians the tools they need to promote language development and improve behaviors in children. “As pediatricians, we need to give parents the skills they need for responsive parenting, which is essential to a child’s ability to thrive in emotional relationships and achieve school success,” said Dr. Quinn. “We are also taking these initiatives and scaling so we can get it to health care settings all around the country.”
In addition to serving as panelists, Mount Sinai clinicians were on hand to provide complimentary skin and heart screenings for Aspen Ideas Festival participants. A team of dermatologists from the Kimberly and Eric J. Waldman Department of Dermatology at Mount Sinai provided nearly 600 skin cancer screenings, identifying four possible melanomas, the most deadly type of cancer, and 40 potential non-melanoma skin cancers (basal cell and squamous cell carcinomas). Mount Sinai Heart experts offered complimentary blood pressure and cholesterol screenings to more than 500 participants.
Maley Thompson from Seattle gets a yearly skin screening in Aspen with Mount Sinai dermatologists. Last year, a Mount Sinai doctor identified an irregular mole on her neck. “I was shocked when they found something because I always took for granted that I was going to be fine,” said Ms. Thompson. “I am fairly young, my skin feels fine, and I live in Seattle where it is always cloudy.”
Mount Sinai dermatologists urged Ms. Thompson to see her local doctor, who performed a biopsy that determined she had a precancerous growth. She underwent surgery last summer and is now fine. “I am so grateful for the Mount Sinai doctors as I would never have gone back to see my dermatologist for another year,” said Ms. Thompson. “Now I know I am at a higher risk of skin cancer because of my fair skin and because I grew up in Aspen where there is high altitude. Thank goodness for the screenings in Aspen.”

Johnson & Johnson Faces Key Test in Defense Against Talc-Safety Lawsuits

Johnson & Johnson, still facing thousands of lawsuits over the safety of its signature baby powder after losing several trials, will make a high-stakes attempt to head off future losses in a courtroom battle beginning Monday.
The company is fighting about 14,200 claims that Johnson’s Baby Powder and other J&J talc products cause cancer. More than two dozen lawsuits have gone to trial in state courts, some resulting in eye-popping plaintiffs’ wins. That includes a July 2018 verdict by a St. Louis jury requiring J&J to pay $4.69 billion to 22 women and their families who blamed ovarian-cancer diagnoses on baby powder.
J&J says its talc products are safe and don’t cause cancer and is appealing the adverse verdicts. The company has also won several trials in state courts.
But most of the talc claims — around 12,000 — are pending in federal courts, and none has been scheduled for trial. A federal judge in Trenton, N.J., Freda L. Wolfson, is overseeing coordinated pretrial proceedings of the federal talc lawsuits, in what is known as multidistrict litigation.
Before allowing any of the federal lawsuits to proceed to trial, Judge Wolfson is weighing the strength of the scientific evidence behind plaintiffs’ claims — the focus of a dayslong hearing scheduled to start in Trenton on Monday.
Plaintiffs’ attorneys have identified expert witnesses including biologists, physicians and epidemiologists who have concluded there is scientific evidence that talc use can cause ovarian cancer.
Many of the women who sued J&J used talc powder for feminine hygiene, and the lawsuits allege that talc particles can migrate to the fallopian tubes and ovaries, and trigger an inflammatory process leading to cancer.
In May, J&J filed court motions asking Judge Wolfson to exclude from any future federal trials the opinions of 22 expert witnesses retained by plaintiffs, arguing that “they misapply scientific principles” and “engage in unsupported leaps of logic.” Lawyers for J&J wrote: “In a nutshell, this is science for the courtroom, not science for the laboratory.”
John H. Beisner, an attorney for J&J with Skadden, Arps, Slate, Meagher & Flom LLP, said in an interview that if Judge Wolfson finds there isn’t enough evidence of causation to present to juries, “there’s nowhere for these cases to go,” which could result in their dismissal, wiping out the majority of talc lawsuits against J&J.
Plaintiffs’ lawyers have asked the judge to deny J&J’s request, arguing that the experts are qualified and used reliable methodologies to reach their opinions. The plaintiffs say there are about 35 peer-reviewed studies that show a link between talcum powder and ovarian cancer, most pointing to an increased risk of between 25% and 45%. The plaintiffs’ lawyers also have argued that the opinions of certain of J&J’s 18 expert witnesses should be excluded from trials.
“This is a really important step and an opportunity to put forward what we think is really overwhelming and reliable evidence,” said Leigh O’Dell, one of the co-lead counsel for plaintiffs in the federal talc lawsuits.
At the hearing, expected to last more than a week, some of the expert witnesses for both sides will face questions from the judge and lawyers. The judge could take weeks or months to reach a decision. If she allows plaintiffs’ expert testimony about causation, it could clear the way for federal trials to begin.
The proceeding, called a Daubert hearing after a 1993 U.S. Supreme Court case, is a pivotal point in litigation alleging products or drugs cause medical harm. Companies can severely curtail claims and sometimes even defeat them completely at the Daubert level.
The Daubert standard, used in all federal courts and many states, requires judges to consider the soundness of the scientific methods experts employ, as well as whether the expert is qualified and the evidence is relevant.
“The idea is that when an expert testifies in front of a jury, we know that jury is going to give that testimony a significant amount of weight, ” said Adrienne Franco Busby, a partner with Faegre Baker Daniels who defends drug and medical-device makers in product-liability litigation, and isn’t involved in the talc litigation. “This is a third party coming to give some specialized technical knowledge. So when they do that, it has to be legit.”
State courts including those in California and Missouri have so far cleared many baby-powder experts who have testified for plaintiffs at trials. A New Jersey judge in 2016 threw out the expert evidence in talc litigation there, which plaintiffs have appealed.
The cases consolidated in the New Jersey federal court involve only those tying baby powder to ovarian cancer. Many plaintiffs’ lawyers have pivoted to filing lawsuits in state court claiming use of J&J’s talc powder causes a rare form of cancer linked to asbestos known as mesothelioma.
Publicity over talc safety has weighed on the company, which has responded by taking out newspaper ads and setting up a website to counter the allegations. J&J shares are down about 11% since December on concerns about the product-liability litigation, and related investigations by the Justice Department and the Securities and Exchange Commission.
J&J booked a $190 million charge in the second quarter for legal-defense costs in the talc litigation.

Next courtroom battle for Johnson & Johnson

Facing thousands of lawsuits over the safety of its signature baby powder, Johnson & Johnson (NYSE:JNJ) will make a high-stakes attempt to head off future losses in a courtroom battle beginning Monday at a hearing that will determine whether federal lawsuits against the company will proceed to trial.
More than two dozen lawsuits have already gone to trial in state courts, some resulting in major plaintiffs’ wins.
That includes a July 2018 verdict by a St. Louis jury requiring J&J to pay $4.69B to 22 women and their families who blamed ovarian-cancer diagnoses on baby powder.

Saturday, July 20, 2019

Week Ahead In Biotech: Pharma Earnings Pick Up Pace

Biotech stocks had a relatively muted performance last week. Johnson & Johnson JNJ 1.32%kick started the second-quarter reporting season for big pharma companies, beating forecasts and an upward adjustment to its full-year sales guidance.
Here are the key catalysts for the unfolding week.

Conferences

  • 10th International AIDS Society, or IAS, Conference on HIV Science – July 21-24, in Mexico City
  • The American Society of Retina Specialists, or ASRS, Annual Meeting – July 26-30, in Chicago

PDUFA Dates

The FDA is set to rule on Celgene Corporation’s CELG 0.76% sNDA for Otezla to treat Bechet’s disease. The decision is due Sunday, July 21.
Biohaven Pharmaceutical Holding Co Ltd BHVN 1.44%‘s NDA for amyotrophic lateral sclerosis drug BHV-0223 is up before the FDA, with the regulatory agency expected to rule on the NDA July 25.

Clinical Trial Readouts

Merck & Co., Inc. MRK 1.57% is scheduled to release Phase 2b 48-week data for its HIV drug MK-8591 at the IAS 2019 conference on Wednesday, July 24. The company recently received FDA nod for its antibacterial medication for complicated urinary tract infection and abdominal infection.
Kodiak Sciences Inc KOD 2.47% will present Phase 1b data at the ASRS annual meeting on Saturday, July 27.

Earnings

Tuesday, July 23

  • Biogen Inc BIIB 0.41% (before the market open)
  • Edwards Lifesciences Corp EW 0.66% (after the market close)
  • Quest Diagnostics Inc DGX 1.56% (after the market close)

Wednesday, July 24

  • Anika Therapeutics Inc ANIK 1.12% (before the market open)
  • Boston Scientific Corporation BSX 0.89% (before the market open)
  • Integra Lifesciences Holdings Corp IART 0.86% (before the market open)
  • The Medicines Company MDCO 2.51% (before the market open)
  • LeMaitre Vascular Inc LMAT 1.55% (after the market close)

Thursday, July 25

  • Baxter International Inc BAX 0.06% (before the market open)
  • Bristol-Myers Squibb Co BMY 1.61% (before the market open)
  • West Pharmaceutical Services Inc. WST 0.57% (before the market open)
  • Novocure Ltd NVCR 2.31% (before the market open)
  • ResMed Inc. RMD 1.07% (after the market close)
  • Merit Medical Systems, Inc. MMSI 1.36% (after the market close)

Friday, July 26

  • AbbVie Inc ABBV 0.42% (before the market open)
  • Zimmer Biomet Holdings Inc ZBH 0.5% (before the market open)

IPO

Castle Biosciences, a genomic testing company for diagnosing dermatological cancers, is set to offer 3.33 million shares in an IPO at an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol CSTL.

IPO Quiet Period Expiry