Good morning. The battle over the battle of Obamacare repeal comes to a sort-of head today as both President Obama and Vice President–elect Mike Pence march to Congress to shore up their respective troops. The pep talks won’t change much. Like some staged Civil War reenactment, both sides will initially hurl themselves at each other with their rhetorical Bowie knives and revolvers. But the real fight will almost certainly slog on for months, as Kelsey Snell and Mike DeBonis have reported in the Washington Post.
In terms of procedure, one oft-mentioned strategy is for Republican Congressional leaders (who have only a slim majority in the Senate) to use a convoluted parliamentary workaround called “budget reconciliation” to strip away the financial circuitry and plumbing of the Affordable Care Act, even as they leave the legislative framework standing. Think of that approach as marauders rushing into a new construction project and absconding with all the electrical wiring and copper pipes.
But there have been increasing cries—including late yesterday from the American Medical Association, the influential guild for U.S. physicians—not to dismantle the existing, if flawed, Affordable Care Act before settling upon a replacement. Even some diehard Obamacare antagonists, such as Sen. Rand Paul, have upped their warnings about killing the nearly seven-year-old legislation in piecemeal fashion without having a full substitute at the ready.
So what would that replacement look like? Well, let me grab my crystal ball.
Hmm, I see something….faint, but ah yes, it’s becoming more clear. There’s a bill—many months from now. It makes sure not to pull the rug out from the 20 million or so Americans who have gotten health insurance under the ACA. (They have to have coverage of some kind, of course.) And this bill keeps the provisions that Donald Trump says he wants to keep—and that millions of American voters want to keep—like those that prevent insurers from blacklisting people with preexisting medical conditions and that allow parents to include their slacker twentysomething kids on their own policies. And natch, this legislation has mechanisms that makes sure there’s an intact marketplace of insurers, and that people aren’t freeloading off of the hefty premiums paid by hardworking Americans: This is a conservative plan, after all.
Sure, some will scoff and say it looks an awful lot like Obamacare. But it’s nothing like it. This bill, for instance, has a rock-ribbed Republican name. Yes, I can see the letters getting sharper now in the crystal ball: Freedom-care.
More news below.
CES approaches with promises of next-gen medical tech. The Consumer Electronics Show (CES), one of the most closely-watched tech conferences in the world, sets off tomorrow in Las Vegas. And while the confab has increasingly become associated with automakers who show off their next-gen vehicles and consumer products like TVs and virtual reality sets, a number of companies will also be showcasing mobile health apps and futuristic devices to treat diseases. For instance, this year, Neofect is demonstrating a new smart glove device that could allow stroke patients to do hand rehab right at home through games and simulations of everyday activities; a number of firms are highlighting mHealth apps that can serve as both activity trackers and monitors for cardiovascular diseases; and others will demo their updated takes on standard medical devices running the gamut from auto-injectors to hearing aids.
Opioid addiction implant maker Braeburn files for $150 million IPO. Last year, Braeburn Pharmaceuticals became the first company to win FDA approval for a matchstick-sized implant device to treat opioid addiction. The product, Probuphine, can continuously administer medication for up to six months and nabbed its regulatory green light in the midst of a wide-scale U.S. opioid addiction epidemic. Now, the company has filed a NASDAQ IPO through which it hopes to raise up to $150 million. CEO Behshad Sheldon has previously told me that she thinks innovations in drug delivery can change the game for medicines that have been around for decades. “I believe the world is going towards long-acting medicines anyways,” she said in an interview following Probuphine’s approval. “I know of a couple of big pharma companies, one of which we have a research agreement with, that want to see whether their novel products could be made into a one-year implant. The world will change the way that medicines are delivered.” (Reuters, Fortune)
Lawmakers introduce bill to scrap Obamacare’s tax on medical devices. Obamacare’s 2.3% tax on medical device manufacturers has always been on the law’s most unpopular provisions – at least in Congress, where it’s come under consistent attack from bipartisan groups of lawmakers facing pushback from the well-oiled device lobby. It’s already been suspended for two years (but is slated to make a comeback in 2018). Now, two Minnesota Congressmen (one Republican and one Democrat) have introduced a bill to do away with the surcharge for good. “We are already seeing new American jobs and increased investment in research and development as a result of the temporary suspension of this tax,” said Rep. Erik Paulsen in a statement introducing the legislation Tuesday. “With over 200 cosponsors at the start of this new session, and with overwhelming bipartisan support in the past, permanent repeal should be a top priority for Congress.” The repeal would likely be included in a broader budget reconciliation bill to dismantle Obamacare’s funding mechanisms, as Cliff mentioned in his essay.
Judge slashes $1 billion jury verdict against Johnson & Johnson. Once again, a federal judge has put the brakes on massive damages awarded to plaintiffs in J&J’s ongoing legal skirmishes over its Pinnacle artificial hip implants. J&J had been accused of hiding problems with the implants from doctors and patients, and a jury awarded six plaintiffs in the case $1.04 billion. But the judge ruled that about $500 million in punitive damages were excessive. “Constitutional considerations limit the amount a plaintiff may recover in punitive damages,” said U.S. District Judge Ed Kinkeade in Dallas in his ruling. J&J has long maintained its innocence over the devices, but still faces about 9,000 lawsuits concerning them. (Bloomberg)
Top Novartis cancer exec heads over to a besieged Gilead. Gilead is recruiting some major pharma star power in an attempt to move forward from a difficult 2016 that saw flagging sales in its flagship hepatitis C drug franchise and a massive drop in market value. The California biotech has appointed Dr. Alessandro Riva, the current head of pharma giant Novartis’ oncology unit, as a senior vice president overseeing its cancer and hematology programs. “I look forward to working alongside Gilead’s dedicated and passionate colleagues throughout the R&D organization to tackle the cancer research and development challenge with a goal of improving the lives of patients,” said Riva in a statement. Gilead’s hep C troubles have been coupled with a number of prominent recent failures in its experimental pipeline and setbacks for blood cancer drug hopefuls. Many analysts have argued that the company needs to use its considerable cash reserves to strike more M&As and licensing deals, particularly to shore up the oncology unit.
Shire spins off its mRNA platform to Boston biotech RaNA Therapeutics. In 2014, rare disease drug maker Shire teamed up with the Cystic Fibrosis Foundation to test out an experimental technology platform to treat the chronic genetic condition, which affects the lungs and digestive system. The tech in question involves using messenger RNA (mRNA) to instruct the body’s cells to create certain proteins that are hobbled by the disease and is still in very early stages in the clinic. Now, Shire is spinning this mRNA R&D unit off to the biotech RaNA Therapeutics, which is an mRNA specialist, in exchange for an undisclosed amount of equity in the firm. “Having this new platform opens up a vast amount of target space for us,” RaNA chief Ron Renaud tells Endpoints. (Endpoints)
THE BIG PICTURE
Newly-introduced bill would bar SCOTUS from citing its own Obamacare cases. GOP Congressman Steve King of Iowa introduced a whopper of a bill on Tuesday that would prevent the Supreme Court from citing its own Obamacare cases in future legal considerations. King’s bill specifically cites the three major cases that went to the high court over the past five years: NFIB v. Sebelius; King v. Burwell; and Burwell v. Hobby Lobby. The congressman, a longtime Obamacare foe, cites the Constitution as the source of power for Congress to impose such restrictions on SCOTUS. “By prohibiting the Supreme Court from citing Obamacare cases, we will be truly eradicating this unconstitutional policy from all three branches of government so that the repeal will be complete,” he said in a statement. (Washington Examiner)
Every French citizen will now be an organ donor by default. New rules in France that went into effect on the New Year has turned the country’s organ donation system into an opt-out one wherein people will have to specifically sign up with a National Rejection Register to prevent themselves from becoming organ donors. The opt-out rules have been embraced by a number of other countries including Spain and Austria, as well as Wales. While controversial, advocates argue such a system could significantly curtail organ transplant waiting lists. (The Independent)
SpaceX and Boeing Win 4 More NASA Manned Missions to Space, by Lucinda Shen
Here’s How Nokia Plans to Invest in Smart Devices, by Don Reisinger
|Produced by Sy Mukherjee|
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