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BioC: It's not too viable in the US. A lot of our lakes are very polluted - high levels of mercury from coal burning. I would not eat any wild or farmed fish out of one of our northern great lakes. Yes, algae makes more sense since the bio-reactors are next to the source.
Also, Democrats are very opposed to GMO - that's why they want it on labels. I was screamed at by one here in Seattle at their booth during an artwalk years ago when I questioned why GMO opposition was part of their local platform. I walked away quickly. (I'm not making a political statement, just repeating what Democrats stated directly to me).
NW40K: Yes, wild Alaskan salmon is tops - any of the 5 varieties.
Farmed salmon used to be great, too, but the big growers out of Norway and Chile (smaller production in Scotland & Iceland) have reduced the inclusion rate of fish oil in the feed such that there isn't as much EPA/DHA as there used to be 7+ years ago. Norway reductions have been greater than Chile even.
Some of the farmed salmon growers are fighting that trend. I think in Scotland - they are trying to focus on keeping a "high-end" farmed salmon available. But, if they aren't rewarded in the marketplace, they'll give way, too. Most consumers don't discriminate. It's like milk - to a consumer milk is milk: most don't distinguish between CAFO grown milk producing cows and grass & ranch raised.
Our food systems are a bit taxed at 7 billion people - its clear when looking at how the nutrient composition has broken down because we tend to focus on volume output and think everything is hunky-dorky (and it is if that is the only metric) - not the composition of that output. We avoid thinking about how much additional in terms of chemical input we need to sustain it as well. We are feeding more people than ever, but with what and at what cost...Stanford University has taken the lead on these studies - they have a Center on Food Security and the Environment - Dr. Rosamond L Naylor especially. The furor to find solutions died down after the international food shortages in 2008-9, so I'm not sure how much grant money is still going to fund efforts for new solutions.
Kiwi: Thanks, no not yet. But CELG's news today wow! I had been wondering about buying a few shares because it did seem like they were underpriced. Instead I waited...
AMRN is definitely a BO target as we all know. So, even if likely no news out of JPM - 2019 is going to be interesting watching for any and all tells. The euphoria has been driven out of the stock now, so time and patience... I saw another story in STAT this morning about how many people were laid off in pharma in 2018 (that Medicare $12B attachment provided the perfect excuse for mass layoffs) - no wonder AMRN had 15,000 apply for the sales jobs. (I'm still connecting all the macro dots)
PS: I got an email back from Dr. Eric Decker (not sure why I wrote in my other post to you "Keith"). He suggested a call next week. I also am now registered for his 2 day short course on lipid oxidation in March out at UMass Amherst. (He said questions were "good" ones, too). I'll keep you posted on anything "new" as I get eddercated. The struggle is real. LOL!!
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Please let us know if you have any further questions or concerns, we look forward to welcoming you to campus in March 2019!
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BioC/Zu: non-starter for now on GMO tilapia (carp), but that would work for China's domestic market. People don't want GMO fish (yet) - see previous discussions on Aquabounty. I don't understand why people have no problem with CRISPR (remove a gene), but are deathly afraid of GMO (add a gene).
Think of the reaction to the twin genetically edited babies in China a few weeks ago. China is already cracking down as they were caught off-guard.
Also, tilapia consumption in the US has been on the decline in recent years (plenty of supply on domestic broilers, pork and beef in US after the ethanol craze keeping these protein costs down for consumers). See what happens if tilapia were to get called "Chinese carp" in the marketplace (case study: Vietnamese catfish wars re:pangasius) and watch the domestic boys down in MS and AL get going again to Congress and ITC. If people in the US knew what Chinese tilapia were fed and the conditions they were grown in, excepting from Hainan Island - they'd never eat it. The fresh tilapia flown in from Latin America is fine, however.
Anyway, IMHO the ideal is not necessarily algae except for niche high end markets. For mass markets it makes more sense if we can grow it in our grains, soy, and corn. Hence, why the ABCD's are looking at it as I've talked about before. This still doesn't solve the problems that Americans over-consume food. People don't exercise self-control over what they put into their mouth. We must get over our fixation with quantity and focus on quality.
AMRN's 10 year patent life is probably about perfect before competitive products become available.
More from Stat today on JPM from AF-
On the cusp of the ‘JPM,’ here’s a cheat sheet for what to watch in biotech in 2019
By ADAM FEUERSTEIN @adamfeuerstein JANUARY 2, 2019
It’s that time of year again.
I’m speaking, of course, of the J.P. Morgan Healthcare Conference. Starting Monday, management teams from hundreds of biotech and pharma companies will file into the Westin St. Francis Hotel on the western side of San Francisco’s Union Square. Over four days, these executives will stride up to podiums in conference rooms large and small to pitch their company’s investment story to crowds of Wall Street investors sitting in uncomfortably close quarters.
This is the 37th edition of what is known colloquially as “JPM.” It’s the oldest, largest, and most consequential investor conference on the biopharma industry’s calendar. With the new year still fresh, JPM is the uniquely scheduled confab where biotech and pharma executives offer their first forecasts, milestone timelines, and financial guidance for the 12 months ahead.
Investors take notes, ask questions, listen for answers (truthful or otherwise), and start figuring out which stocks they want to buy, sell, or avoid.
And journalists like myself are on hand to listen and report on what’s being said in those presentations — or more importantly, in the hallways during breaks.
To set the table for JPM19, here are what I see as some of the burning questions that will make or break the most closely followed biotech companies in the coming year.
Amgen: The commercial launch of its migraine drug Aimovig exceeded expectations in 2018, but will that trend continue this year as more competitors hit the market? What happens to Neulasta sales now that a biosimilar has been launched? How will the Enbrel patent litigation case be decided? Will Amgen continue to use its cash on share buybacks and dividends, or engage in a blockbuster M&A deal? Is a mega-merger between Amgen and a Big Pharma company in the cards for 2019?
Gilead Sciences: Welcome, new CEO Daniel O’Day. What is your business and strategic plan for Gilead? Is this the last year of declining earnings and revenue before the company starts growing again? Will two key late-stage clinical trial readouts — selonsertib in NASH and filgotinib in rheumatoid arthritis — succeed or fail? Can Biktarvy keep Gilead’s dominant position in HIV intact? Can cancer cell therapy — Yescarta, in particular — grow into a commercially meaningful business?
Biogen: Will there be an interim analysis of the aducanumab Phase 3 Alzheimer’s study? How will Spinraza continue to perform if (when) Novartis’ gene therapy for spinal muscular atrophy is approved toward the middle of the year? Will Biogen acquire an innovative biotech to diversify away from its reliance on an aging multiple sclerosis franchise and an ultra-risky Alzheimer’s drug candidate?
Alexion Pharma: Ultomiris is approved, so how quickly can the company convert patients from Soliris? Can Alexion fend off competitors seeking to develop their own drugs to treat complement disorders?
Celgene: Is a CEO change necessary to turn around rock-bottom investor negativity and the plunging stock price? Will a settlement with Dr. Reddy’s over generic Revlimid finally happen — and on favorable terms? Can the company execute on regulatory filings and late-stage clinical trial readout for its “Big 5” pipeline products: fedratinib, ozanimod, luspatercept, JCAR017, and bb2121? Even if all goes well with the Big 5, will investors start buying the stock or does Celgene still need to do more?
Vertex Pharma: How fast can the triple combination regimens in cystic fibrosis be filed, approved, and launched? Is there any remaining threat from cystic fibrosis competitors? How will Vertex manage patient access and reimbursement, particularly in Europe where regulators have balked at high prices? With profits from cystic fibrosis treatments accelerating, how does Vertex choose to use its cash?
Bluebird Bio: The first approval for Lentiglobin in beta-thalassemia is expected this year in Europe, so how will the gene therapy be priced and are enough patients willing to undergo the procedure? The multiple myeloma CAR-T partnership with Celgene is complicated by Celgene’s ownership of potentially competing therapies from Juno, so how is the company planning for potential conflicts? How fast can the “accelerated” Lentiglobin development plan in sickle cell disease deliver regulatory filings and approvals?
Sage Therapeutics: Will SAGE-217 succeed in the Phase 3 study in postpartum depression? If the study reads out negative, what changes, if any, will be made to the SAGE-217 development plan or regulatory filing timeline? Can the company deliver a strong commercial launch of Zulresso (brexanolone) in postpartum depression once the drug is approved in March?
Regeneron Pharma: Will the Dupixent commercial launch in asthma duplicate the drug’s strong showing in atopic dermatitis? Can Regeneron maintain growth in its core Eylea franchise? Will the recent approval of Libtayo and the advancement of its pipeline products help the company become a significant player in immuno-oncology?
Biomarin: Will the efficacy of the hemophilia A gene therapy valrox remain durable when three-year data are disclosed in the middle of the year? Can Biomarin file valrox for accelerated approval in 2019? Will the Phase 3 study of vosoritide in achondroplasia (the most common form of dwarfism) yield positive results at year end? Revenue is growing but when will the company stop losing money and finally deliver sustained profitability?
Sarepta Therapeutics: Will the next clinical trial updates from gene therapy programs targeting Duchenne muscular dystrophy and Limb-Girdle muscular dystrophy impress as much as last year’s initial data readout? Is this the year that Sarepta is finally acquired?
Agios: New CEO Jackie Fouse starts in February. Will she make major changes to the company that differ from founder and first CEO David Schenkein?
Intercept Pharma: Will the first-half 2019 interim analysis of the obeticholic acid (OCA) Phase 3 study in NASH read out positive with no significant safety issues? And if the OCA data in NASH look clean, how quickly can an accelerated approval filing be submitted? What impact will competing clinical trials of NASH drugs have on investor outlook for OCA?
Alnylam Pharma: Will the report of fourth-quarter 2018 sales for Onpattro plus management discussion of first quarter performance be strong enough to overcome doubts investors have about this orphan drug launch? Will Alnylam’s next RNAi drugs givosiran and lumasiran succeed in their own respective Phase 3 trials?
Related: Massachusetts is trying to make the Berkshires a biotech hub. Can it succeed where so many other cities have failed?
Acorda Therapeutics: Inbrija was approved early, but can the Parkinson’s drug meet or beat sales expectations in its first year on the market — enough to make up for falling Ampyra sales?
Alkermes: How big is the commercial market opportunity for ALKS3831 in schizophrenia? Assuming the FDA rejects ALKS5461 in depression, will the company shake up its R&D strategy and pipeline?
Amarin: What evidence can management provide — higher sales, a boost in prescriptions — to show that Vascepa is leveraging the REDUCE-IT study results to blockbuster status?
Solid Biosciences: Can the first look at data generated by its gene therapy for Duchenne muscular dystrophy match or surpass what’s been shown by Sarepta Therapeutics?
Sangamo Therapeutics: Will updated data from MPS II patients treated with its zinc finger genome editing therapy erase doubts raised last year by the first, confounding study results?
Myovant Sciences: Will readouts from a trio of Phase 3 clinical trial programs for lead drug Relugolix vindicate Vivek Ramaswamy and his Roivant business model? Or, will his hard luck continue?
GW Pharma: How much will the growing awareness of (and enthusiasm for) cannabinoid-based drugs help Epidiolex perform commercially in its first year on the market?
In STAT today - PhRMA's $12B epic fail of 2018 & mood into 2019:
How PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years
By NICHOLAS FLORKO @NicholasFlorko JANUARY 2, 2019
MIKE REDDY FOR STAT
WASHINGTON —The drug industry’s storied lobbying group isn’t accustomed to bad news — and with its small army of well-connected advocates, it’s even less familiar with surprises.
For PhRMA, the news last winter was both.
On Feb. 7, the group’s board — made up of dozens of the CEOs of major pharmaceutical companies including Amgen, Johnson & Johnson, and Sanofi — was gathered for a meeting to welcome its new chairman. Suddenly, the gathered crew had something far more threatening to discuss: Congress had just laid out a plan to force drug makers to pay far more into Medicare — a policy change none of pharma’s lobbyists had seen coming.
A source familiar with what happened at the meeting described the atmosphere succinctly: panic.
The group — its board members, its 30 internal lobbyists, and its 150 contracted ones — sprung into action, scrambling to convince Congress not to enact the change. That two-day blitzkrieg was only the first in a series of sustained campaigns to find a way to reverse its loss — campaigns that saw the powerful group make concessions on policies it otherwise opposed and even reach out to would-be adversaries.
But all that maneuvering was for naught. On Tuesday, it became official: A change took effect that will cost the industry nearly $12 billion over the next 10 years.
“This might well be the biggest political loss that PhRMA has suffered in a decade,” Daniel Carpenter, a professor of government at Harvard, told STAT.
Related: The drug industry is headed back to Congress to make its case. Will Democrats keep the door open?
STAT spoke with key members of Congress, congressional staffers, experts, and lobbyists both within the drug industry and outside it to piece together the inside story of how the drug industry finally lost — big — in Washington. The account, some of which is reported here for the first time, details just how flat-footed PhRMA was caught by the policy, how it spun together multiple lobbying strategies to advance its “fix,” and how close it came to getting its way.
The account underscores, too, just how vulnerable the group, once thought invincible, has become, as newly empowered Democrats pledge to work with President Trump to lower drug prices. That PhRMA’s quest failed — despite the potentially record-breaking sums it spent on lobbying, despite its myopic, months long focus on the issue, despite its untouchable reputation in Washington — could be the first, early sign that the industry’s towering influence is waning.
Back in early February, before the call came, the outlook for PhRMA was relatively sunny. Sure, Trump had recently derided the drug industry for “getting away with murder.” But the administrative action he promised hadn’t come — the regulatory changes coming out of Health and Human Services under former Secretary Tom Price were more often favorable to the industry than not. His replacement, former Eli Lilly executive Alex Azar, seemed just as friendly. Republicans, the party with which PhRMA has often enjoyed a cozier relationship, still controlled both the House and Senate.
Unbeknownst to PhRMA, however, some of those Republicans had been working alongside Democrats for weeks, endeavoring to hammer out a tiny policy change with massive consequences for pharma.
Slipped into less than half a page of the 250-page bill — the whole section is only 168 words — the new policy requires drug makers to pay a larger share of a Medicare beneficiaries prescription costs when that person is in something known as the “donut hole.” Beneficiaries pay 100 percent of their drug costs until they meet their deductible, and insurers pick up a portion of the tab in the initial coverage phase, until someone has spent about $3,750 in drug costs. Beneficiaries pay even less once they hit the catastrophic phase, after they’ve spent $5,000. In between, though, patients, drug makers, and insurers are together responsible.
Before February, drug makers paid 50 percent of those costs. Now, however, they’ll pay 70 percent — an increase that, spread across the 43 million people who have Medicare drug coverage, adds up to billions in extra funding from pharma.
The broad outlines for the change — which was also included in President Obama’s 2016 and 2017 budgets — came from the four most powerful lawmakers in Congress: Senate Majority Leader Mitch McConnell of Kentucky, Minority Leader Chuck Schumer of New York, then-Speaker Paul Ryan of Wisconsin, and Minority Leader Nancy Pelosi. Staff on all four major health committees, in both chambers, helped draft the technical legislative language.
There was a conscious effort, several congressional staffers told STAT, to make sure PhRMA didn’t catch wind of the idea in the weeks leading up to its rollout. Even the Trump administration knew about the change and managed to keep it quiet, a senior administration official told STAT.
At the time, the lawmakers considered it a “haircut” for the industry, a way to make them cough up a little extra cash to help pay for the rest of the $400 billion budget deal, which dedicated funds to rebuilding Puerto Rico after Hurricane Maria and fighting the opioid crisis, among a host of other issues.
It’s a time-honored tradition for Congress to turn to industry to help pay for other legislative spending. Hospitals might see certain Medicare payments dwindle as a “pay for” for other health priorities. Congress will sometimes build in a direct excise tax, like the one it placed on medical devices as a way to offset other costs in the Affordable Care Act.
But no one — neither PhRMA nor the drug pricing advocates who so often work against it — expected congressional Republicans to deliver on an Obama-era priority that would hurt the drug industry.
“We were surprised by the magnitude of the policy change initially,” PhRMA CEO Steve Ubl told The Hill in May.
Even now, months later, Washington hasn’t coalesced around a single explanation for McConnell and Ryan’s decision to give pharma that “haircut.” Several sources inside and outside the government suggested Republicans were fed up with the industry and ready to send a message they weren’t invincible anymore. Others say Republican staffers didn’t know quite how big a policy change they were putting forward. Many pointed to the high-pressure budget negotiations and the need to find something — anything — to pay for February’s spending deal.
“You need a pay-for for your bill, you have [all four congressional leaders] agreeing to it. Why would you give PhRMA a call to have them screw it up?” one staffer asked. “It’s not like they’re going to be like, ‘OK, thank you.’”
(McConnell and Ryan’s offices both did not respond to request for comment on this topic.)
Part of the reason PhRMA was flat-footed: They thought Congress was working to push an entirely different policy, the congressional staffer explained. Several prominent lawmakers, mostly in the Democratic party, had been eyeing the CREATES Act, a bill that would allow generic drug companies to sue their brand competitors when they’re allegedly blocking competition. The bill had long been opposed by PhRMA, but it wasn’t nearly as consequential as the donut hole change that made its way into the bill.
And once the policy was out in the public eye, the drama of that early February board meeting didn’t fade fast.
PhRMA was “twisting every arm, trying to use the influence of their campaign contributions in both parties,” Rep. Lloyd Doggett (D-Texas), one of the most vocal advocates for lower prescription drug prices in Congress, told STAT in late December.
The group went “berserk,” as one lobbyist for PhRMA put it.
PhRMA’s members were gobsmacked that the group could be surprised by such a big change, especially when Republicans were in control. “We pay you guys so much goddamn money in dues to be our eyes and ears,” a second drug industry lobbyist griped. “How could you let this happen?”
“It was kind of a watershed moment, [a realization] that we can no longer rely on a solid red line of support,” the second drug industry lobbyist added, referring to Republicans.
Pill bottles and money
PhRMA didn’t give up on its pushback when Trump signed the February budget deal into law. Congress, after all, has a rich history of making retroactive changes to benefit a particularly powerful industry group. It’s possible even now that the donut hole policy could be rolled back later this year, though with Democrats in the House it looks unlikely.
Before the ink was even dry on that February deal, the industry was formulating a new strategy: an argument that the “haircut” Congress had intended had shorn off a bit more than anyone expected.
Originally, the Congressional Budget Office, a wonky, nonpartisan outfit that evaluates how much a given legislative agenda item will cost taxpayers, estimated that the donut hole change would save taxpayers (and therefore cost drug makers) $7.7 billion.
PhRMA’s policy wonks and actuaries had crunched their own numbers: The CBO’s estimate was massively off, by more than $4 billion. (The CBO ultimately admitted its error and agreed with PhRMA, acknowledging in May that the change will actually save taxpayers $11.8 billion.)
The group’s new argument, then, was clear: This was a mistake, and Congress should fix it.
“If you make policy for purely budgetary reasons you usually make bad policy, if you do it super fast you usually make it worse and they did both of those things,” said Doug Holtz-Eakin, president of the American Action Forum, a conservative think tank that is closely aligned with PhRMA.
Republicans quickly began shirking responsibility for the change. They hadn’t wanted to cut this deal, they said, but Democrats had demanded it.
“Do I think that we would’ve agreed to some of the changes that were made last week if it wasn’t a large part of a larger budget deal? Probably not,” said Nick Uehlecke, a Republican staffer for the Ways and Means Committee, at an event just a week after the budget deal was signed into law.
PhRMA’s first attempt at getting the policy reversed was about quintessentially Washington as go-go music. All the group had to do was sneak a few sentences into a 2,000 page, $1.3 trillion spending bill that Congress was considering in late March. In the parlance of Washington, a “rider,” on a “Christmas tree” of a spending package.
PhRMA played its cards carefully: It focused on Republican lawmakers like Ryan and McConnell, pressuring them to plead their case with Democrats like Pelosi and Schumer who were much less open to the change. And it tried not to be too greedy: Industry pushed to roll back the percentage it would have to pay from 70 percent to somewhere between 60 and 64 percent, not to revert all the way back to the 50 percent they would have been paying before the February law.
But PhRMA wasn’t so lucky. Democrats didn’t budge, and Republicans didn’t push it.
STAT Plus: Exclusive analysis of biotech, pharma, and the life sciences.
Drug industry lobbyists told STAT PhRMA’s asks weren’t solidified yet — the group never agreed on exactly what percentage, between 60 and 64 percent, that it should be asking for.
“It wasn’t ready for prime time,” the second lobbyist said.
Drug pricing advocates, too, demanded that a slew of Democratic drug pricing priorities — like cracking down on pay for delay deals and abuse of FDA safety systems — be coupled with any rollback to the donut hole change.
Undeterred by its failure in March, PhRMA regrouped and began to rev up its lobbying machine. By the end of the first quarter it had already spent nearly $10 million lobbying Congress — a number that would more than double by September, to $21 million — figures that put it on pace to spend more than it has ever spent in a single year.
At the center of its new strategy, starting in May 2018: a clever new legislative proposal to couple the donut hole change with a more bipartisan and popular Medicare fix and brand the entire thing as a way to shore up Medicare. That other, unrelated policy would address a so-called “impending Medicare cliff” that won’t take effect until 2020.
On Capitol Hill, PhRMA gave the idea an uncontroversial name: “the alternative proposal.”
“The alternative proposal consists of both lower manufacturer coverage gap discounts and a policy to address the scheduled increase in the out-of-pocket threshold required to reach catastrophic coverage in 2020,” reads a wonky handout from PhRMA obtained by STAT and never before made public. “Seniors with high drug costs will be better off under the proposed alternative policy than they would under the [February law].”
PhRMA pushed the idea in radio, digital, and print ads, too, in health care and politics-focused publications across Washington and more broadly. One recent report showed that PhRMA sponsored more than 70 percent of POLITICO’s Pulse newsletter in 2018.
They recruited allies to press their case, too. A slew of groups including the National Hispanic Council on Aging, the National Minority Quality Forum, and even the National Grange all sent letters to Congress with a message eerily similar to PhRMA’s: fix the Medicare cliff and lower drug makers’ share of donut hole discounts.
And Congress listened — at least, at first. In May, more than 200 House members — nearly half the body — wrote to congressional leadership calling for Congress to address both issues together. Democrats and Republicans sent separate letters but their message was unified: move on PhRMA’s alternative proposal. (A spokesperson for PhRMA told STAT the organization “didn’t know the letters were coming,” but acknowledged the group was “doing a lot of education” on the issue.)
The letters put supporters of the February change on high alert. AARP, which emerged as one of the strongest opponents to PhRMA on this issue, cut straight to the chase in a letter to Democrats: “We are very concerned that you recently signed onto a letter that called for this beneficiary improvement to be re-visited,” they wrote. Patients for Affordable Drugs also pushed back, blasting Democrats for supporting “Big Pharma” in its own strongly worded letter.
PhRMA’s last, most serious attempt came in late September, as Congress took up a long-sought legislative package to address the opioid epidemic.
It was a shockingly Machiavellian move, even for an organization known for its ruthless negotiation tactics.
The logic: No lawmaker, no matter how anti-PhRMA, could vote against the opioid package. Congress had spent the better half of the year crafting a sweeping package to reform the nation’s addiction treatment infrastructure, and it was expected to sail through both chambers of Congress. If PhRMA could get its donut hole fix into the package, it would would virtually guarantee both parties would vote to enact it into law.
Related: Trump’s new drug pricing proposals have already sparked a war of words with the drug industry
But once word came from the hill that PhRMA was hoping to get its donut hole change looped into the package, advocates pounced, brandishing the policy as a big PhRMA bailout.
“We all rallied around the same message — singing from the same song sheet,” Lauren Blair, communications director for the Coalition for Sustainable Rx Pricing, said.
Soon, top Democrats were also chastising PhRMA for its tactics.“Leader Pelosi opposes this Republican attempt to hijack a bipartisan effort on opioids funding to ram through a multi-billion dollar handout to Big Pharma,” Pelosi spokesman Henry Connelly told The Hill.
While advocates take the credit for sinking the package, the debate over the CREATES Act, the generic industry-backed bill being considered back in February, was still simmering, and clearly played a role in failure of both sides to reach a deal on the donut hole, lobbyists on both sides of the issue told STAT.
Despite its long-held opposition to the policy, PhRMA had been sending signals, even as early as March, that it might be willing to trade the policy in exchange for getting the donut hole change reversed.
That month, House Speaker Paul Ryan personally directed the House Judiciary and Energy and Commerce Committees to write a version of the policy that everyone, including the drug industry, could support. Those negotiations began to heat up in May when Ryan touted the policy at a Washington health care conference.
And when it became clear that PhRMA also needed help getting top Democrats like Schumer and Pelosi on board, PhRMA turned to an unlikely ally: the generics industry, which goes up against its brand counterparts far more often than it works alongside them. It said it would make a deal on the CREATES Act if the generics industry could help get Democrats on board with the donut hole change.
“I sat there with my mouth agape,” a lobbyist close to the negotiations told STAT. “I have been really surprised how little strategic sense they had of how to deal with the Democrats over the last year … it seems to me Pelosi and Schumer were almost an afterthought to them.”
Those negotiations, however, eventually fell apart. The answer to why depends on who you ask. Lobbyists for both sides blamed each other for the stalemate, frequently accusing the other of acting in bad faith.
PhRMA never again got so close to getting the fix it so desperately wanted. Industry lobbyists kept pushing through the fall, suggesting the policy could advance in this way or that, but no solid effort materialized. It never came up in end-of-year spending bill negotiations.
Ways and Means Committee Chairman Kevin Brady (R-Texas) told STAT in late December there simply wasn’t “bipartisan consensus,” to make the change. He, like many others, emphasized that it had been a priority for Ryan, who’d pulled for pharma across all four attempts. Democrats, he said, were just more successful.
“I get the impression that PhRMA/BIO and their member companies have come to accept the fact that the Part D change is here to stay,” the second drug industry lobbyist told STAT in an email. “Most, in fact, have already factored the Part [D] change into their earnings expectations – and cut employees and made other reductions.”
Now, after a midterm election season that focused more on drug prices than any before it, Democrats control the House of Representatives, along with the gavels of key committees with jurisdiction over health care policies like drug pricing. That could make it much harder for PhRMA to advance any of its priorities, let alone the donut hole fix Democrats spent the last 10 months opposing.
“Overturning the coverage gap policy gets much harder once it has gone into effect and once Pelosi is Speaker,” said one health care consultant.
It’s still possible, however, the industry’s coveted “fix” could come before Congress this year, and could even retroactively reverse the cost, lobbyists both within and outside the drug industry said. Though the House is now controlled by Democrats, the impending Medicare cliff, for example, will still need to be addressed, meaning PhRMA’s “alternative proposal” could still become a reality, the second drug industry lobbyist told STAT.
The fix could also come up as a trade if Trump works with Democrats to enact some of the drug pricing reforms he and health secretary Alex Azar have been pushing since May, some suggested to the Washington Post. The Trump administration, for example, has urged Congress to write legislation that would shore up its authority to peg drug prices to what other countries pay, and to require drug prices be included in TV ads.
There are already signs that PhRMA’s members may be less willing, in 2019, to let the issue control PhRMA’s agenda. After all, House Democrats are already readying subpoenas, the Trump administration is becoming more antagonistic toward the industry by the day, and drug companies themselves have already written the new expense into their balance sheets.
As the health care consultant explained: “There’s a lot of conflicting points of view within industry [on] whether this should be their big ask.”
Lev Facher contributed reporting.
Tasty: Haven't heard of that one. The Marvelous Mrs. Maisel on Amazon was my most recent binge watch affliction.
Dolly said it best - "diamond in a rhinestone world."
TN homesick blues
In the WSJ today:
Fish Oil: Hunting for Evidence to Tip the Scales
As debate continues, studies explore whether fish-oil supplements can help with heart health, depression, inflammation, autism and premature birth ‘There are tantalizing hints that there might be something there,’ says one researcher, regarding fish-oil supplements.
‘There are tantalizing hints that there might be something there,’ says one researcher, regarding fish-oil supplements.
PHOTO: ISTOCK
4 COMMENTS
By Betsy McKay
Updated Jan. 2, 2019 1:20 p.m. ET
Millions of Americans take fish-oil supplements every day, hoping to prevent heart disease, depression, even premature birth. It is one of the most popular dietary supplements in the U.S.
Reams of research exist on fish-oil supplements, but questions remain on their benefits.
Many studies so far suggest the supplements don’t offer the benefits that marketers tout. A recent large, randomized clinical trial found that fish oil taken at a dosage found in many supplements didn’t reduce the incidence of heart disease or cancer, the main benefits with which it is associated.
But scientists are probing further into its potential effects on heart health, including some other findings in the recent large study. They are also digging deeper into potential effects that have been less well studied: on depression, cognition, autism, and other conditions.
“The jury is really still out,” says Joann Manson, chief of the division of preventive medicine at Harvard-affiliated Brigham and Women’s Hospital, who led the recent study on fish oil and heart health and cancer.
Even with the debate, sales of fish-oil and animal-oil supplements rose 1.8% in 2017 to $1.17 billion, the bulk of which is fish oil, according to Nutrition Business Journal.
The key components of fish oil, two polyunsaturated fatty acids called eicosapentaenoic acid, or EPA, and docosahexaenoic acid, or DHA, are designed to be in the membranes of cells all throughout the body. Though these fatty acids are critical to cell function, the human body has difficulty making them on its own, so has to get them from diet. EPA and DHA are found in high amounts in fatty fish such as salmon.
In the 1970s, researchers discovered that Inuit people, whose diet consisted mostly of the fish they caught in the sea, had low rates of cardiovascular problems. That finding spawned thousands of studies into the potential benefits of Omega-3s, a recommendation from the American Heart Association that people eat fish at least twice a week to help prevent heart disease, and an industry of fish-oil supplement makers.
Today, the recommendation to eat more fish stands. But so far, with fish-oil supplements, “you can’t seem to replicate that benefit,” says Craig Hopp, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health, an arm of the National Institutes of Health that funds scientific research on health-care practices and products outside of conventional medicine. NCCIH is currently funding studies investigating whether Omega-3s enhance the effect of antidepressants, reduce inflammation, and help children with autism spectrum disorder.
The problem is the same in trying to reproduce the benefits of fruits and vegetables with vitamins or supplements, he says. Trying to understand exactly what in a diet “is responsible for those benefits is hard to pin down,” he says, noting that it is “probably not just one thing.”
Researchers have identified some benefits. High doses of fish oil can reduce triglycerides, a type of fat in the blood that can raise the risk of heart disease. Some patients with high triglycerides take prescription drugs, whose doses and ingredients differ from over-the-counter dietary supplements.
A recent research review found that increasing intake of Omega-3s, particularly EPA and DHA, reduces the risk of premature birth—a finding that could give fish-oil supplements a boost, as many pregnant women worry about contaminants in fish, says Duffy MacKay, senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, a trade association representing dietary supplement manufacturers. (Industry standards set limits on contaminants such as heavy metals in fish-oil supplements and spell out how to test for and filter them out, he says.)
Ultimate Omega from Nordic Naturals.
Ultimate Omega from Nordic Naturals. PHOTO: NORDIC NATURALS
The study that Dr. Manson led, funded by several NIH institutes and following 25,871 men 50 and older and women 55 and over for more than five years, found that one gram a day of fish oil didn’t lower the risk of heart disease or invasive cancer. But researchers also found a 28% lower risk of heart attack in participants who took fish oil. The benefit was even greater—a 40% reduction—for participants who took fish oil and ate fewer than 1.5 servings of fish a week.
The findings were secondary to the central focus of the study, and need to be studied further, Dr. Manson cautions. Still, she says, “We think there’s a promising signal for a heart health benefit.”
“There are tantalizing hints that there might be something there,” says Pieter Cohen, an associate professor at Harvard Medical School and Cambridge Health Alliance who studies dietary supplements. He says they should be studied further, but also have to be taken into context with many previous studies showing no heart disease benefits. “If someone comes to me and says I’m worried about not having enough Omega-3 fatty acids, I would say eat fish rather than taking a supplement,” he says.
The finding that Omega-3s can help prevent premature birth should also be approached with caution, he says. “The ideal would be to follow these women and their babies so we have more information,” he says.
Using data from the same large study led by Dr. Manson, researchers are analyzing the effects of the fish-oil regimen on depression, cognition, diabetes, chronic pain and other conditions, Dr. Manson says. Results are expected in the next six months to a year, she says.
Olivia Okereke, director of geriatric psychiatry at Massachusetts General Hospital, who is leading the analysis on depression, says she hopes it will provide answers that previous, smaller and shorter observational studies haven’t. Researchers are analyzing participant data for diagnoses of depression, as well as self-reported mood symptoms and how they differ over time, she says.
THE ALPHA AND OMEGA-3 ON FISH-OIL SUPPLEMENTS
The jury is still out on whether fish-oil supplements have benefits for a variety of health conditions. If you do take supplements, here are some things to know.
Check how much Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) a supplement contains.These are the long-chain Omega-3 fatty acids that are the key components in a fish-il supplement. Avoid products that don’t spell out how much EPA and DHA they have.
There is no daily value recommended by the government. The U.S. Dietary Guidelines recommend eating seafood in amounts that equate to 250 milligrams of EPA and DHA a day. The Food and Drug Administration says supplement labels shouldn’t recommend more than 2 grams of EPA and DHA daily, though doctors might prescribe more for patients who need to lower their triglycerides. Everyone’s needs are different, so talk with your doctor. You can get a blood test to determine how much EPA and DHA are in your blood.
Fish-oil supplements should not smell or taste fishy. Good-quality fish oil is processed in a way that prevents oxidation, which causes the fats to break down and smell.
Side effects of taking fish-oil supplements, while rare, can include heartburn, nausea or diarrhea. Patients taking fish oil and blood-thinning drugs such as warfarin should be monitored by their doctors, because high doses of the fish oil may increase the risk of bleeding.
Kiwi: Does oxidized fishoil have negative effects in the body at 4+g daily dosages - I believe that is what you are asking? It's a good question.
My personal opinion is that yes I think oxidized fish oil can be problematic.
I think its a critical quality control point to differentiate Vascepa from DS.
Especially in a gel capsule form where an off-note smell (our easiest gauge of rancidity) is hidden from our senses both by the capsule shell and any deodorizing steps in the processing. Fish oil has a natural fish smell and it is strong...but, it shouldn't smell rancid which is detectable as a bitter smell on the fishiness. If it doesn't smell at all then the oil has simply been deodorized. So, if any oil has been deodorized, not just a fish oil, how could one know without lab testing what the oxidation levels are?
There would need to be a lot of oxidation products in the oil for an individual to be able to answer conclusively if a person's changed biomarkers are specifically due to fishoil oxidation - no other changes for the oil or in a person's diet or physiological state? If all else is equal, then yes polyunsaturated fatty acids are horribly unstable and highly reactive and could affect all the biomarkers you understand with may more personal knowledge than me.
Research is still teasing out these answers and many would disagree with me with respect to lipid oxidation products being harmful. First, they might argue about which stage of lipid oxidation products am I referring to? Different lipid oxidation products get taken up at various waypoints along the GI tract or make it past the GI tract unabsorbed like lipid hydroperoxides (1st stage oxidation products) vs others like fatty acid decomposition products such as aldehydes (second stage) that can be found in chylomicrons.
Secondly, they would say most of the oxidation products can get cleaned up during the refining. That's largely true, but then more solvents and deodorizing agents are needed so the residuals of those molecules doing the scrubbing then will be higher (need to keep those in an acceptable range as well) unless you can verify that all of those get scrubbed out during later refining steps. There are plenty of other arguments that could be made here rebutting my opinion.
The lipid breakdown process starts when free radical thieves begin stealing hydrogen from all those reactive polyunsaturated fatty acid double bonds. Next, hydroperoxides and alkoxyl radicals form and the all other by-products from the cascade of reactions.
For me, it's telling that otherwise robust aquaculture fish suffer weaker immune systems and sometimes die when their feed is too rancid and a feed producer like say Cargill may trace it back to the fish oil since its among the more reactive oils in the feed composition. As with our pets, fish diets aren't changed much (usually there is a starter diet, then mid-life and finally a finishing diet before being harvested in addition to specialty diets). So, if the lipids have oxidized to the point of rancidity and they are fed the exact same feed pellets every day and continue to eat then it becomes a problem. Sometimes just like with our pets it may affect palatability first, that is they won't even eat their diet.
Also, all lipids have some oxidation products.
- High quality oils are about 10-100 nmol hydroperoxides/g lipid
- These levels are 400-1000 times greater than the hydroperoxide concentrations found in lipids in living tissues, right?
Kiwi - if you'd like please feel free to PM me your email address & I can send you some literature which goes over the complexity better for your own review. I can also keep you informed of what I find out as its been suggested to me in the past to reach out to Keith Decker at UMass since I had questions, too.
C: Wisconsin (Michigan and Minnesota, too) put out a lot of state public health advisories regarding mercury contamination from coal burning (enters the Great Lakes, streams, & air). They work with the USEPA (and FDA) to coordinate their efforts on the advisories.
Mercury accumulates in all tissues and increases our body burden. You are right. However, it's a quantity thing, so while there are NO GOOD quantities at least there are levels less likely to cause measurable harm outside of pregnancy and the early years for humans. And we still need to eat more fish as part of our American diet as these two doctors below say.
Here's a good video on mercury from WI DNR with interviews of Dr. Emily Oken, MD-MPH and Dr. Dariush Mozaffarian, MD-DrPH. The video makes the good point that mercury bio-accumulates in larger, older fish like yellowfin (or bluefin) tuna versus smaller fish like anchovy. Small pelagics have shorter lifespans - maybe about 5 years on average, but are generally caught when about 1+-2 years (minimum size restrictions).
Wisconsin DNR mercury
The USEPA has copious data on the subject as the agency has some of the country's premier toxicologists studying mercury.
US EPA mercury
ILT: There really aren't any "compliance" protocols for DS. They are voluntary and self-policed, but do include oxidation. That's what Dr. Preston Mason was referencing with the monograph.
I enjoy reading your posts, by the way regarding your brother. You might mention to him that the August 2018 magazine of Le Point (like a French Economist) has a big review of French Hospitals & Clinics.
C - It could be any # of labs - there are hundreds of them, e.g.:
- Eurofins
- Matis
- Exova
- Intertek
The first step in fish oil refining (short path distillation) removes most of the contaminants like mercury. Not all DS makers are created equal. Clearly some are more responsible than others.
Here's a lab posted voluntarily to Ifos for the OmegaVia 500 EPA rTG (which I've described in an earlier post as being a voluntary organization for the more responsible DS makers to submit their labs for a given batch of O-3). I myself would not be worried about 10mg of DHA in a 500 mg pill even if I had CVD. Also, the color is removed in the processing of the fishoils to make it clear as I stated in an earlier post. It's called the Gardner score - for V the Gardner score is 0 after processing (show the purity to the naked eye). Natural fish oils vary depending on what the fish have been eating - their scoring could range from 8-14. If the fish have been eating more krill than the oil will be more red. If they have been eating more copapods or worms then the oil will usually be more yellow.
I think its important to remember that Dr. Preston Mason's video - while I thought it was very good is still a marketing tool to promote V created by a biomedical research firm for AMRN - they crank out studies on demand. That doesn't diminish it's message, but I thought when I watched the video originally posted the week after AHA by Zu as I recall, that it was a little bit wonky regarding the processing slides and that fishoil is used to feed animals (like for aquaculture).
We all are animals. The FDA approval processes to certify plants are practically the same, just parallel, regarding approvals for human or pet food plants for example. The reason? Because some Americans eat pet food.
Lipid oxidation is a problem for all oils - Americans consume a lot more soy and corn oil than fish oils. We should start with reducing our edible oils consumption.
Global oils consumption by type:
I don't know if anyone else on the board has read Dr. Cate Shanahan's book "Deep Nutrition" (first edition was 2008 and then she updated it last year) - I just started reading it. She's a PHd in Biochemistry out of Cornell and a MD from Rutgers. Plus, she spent 10 years in Hawaii studying ethnobotany. Pretty fascinating especially her focus on epigenetics and it more than helps her cover for the lack of nutrition training in a typical MD curriculum as she said. Also, in the hierarchy that is modern medicine nutrition is lower on the hierarchical totem pole compared to other subject areas. Preventative medicine is often seen as a "womans" domain, ...or so I've heard.
Strange since maybe if there had been enough other doctors grounded in the science they could have more effectively challenged Dr. Ancel Keys back in the 50's before we got into this CVD mess. US soy consumption (and I believe edible oils are about 30%? of our 1800-3000 calorie American diet...)
I may read this one next:
Typical medical school curriculum (the 4 years before residency) - I don't see too much human nutrition:
I wonder if Dr. Preston Mason is still planning on presenting in Portland at the end of Feb. at the Clinical Lipid Update I may drive down to see if can listen in.
Thanks for that blog link Evil - just bookmarked it. It's a good one. Do you know if there is a similar blog for CAFC? I was trying to find some of CAFC's % stats on decisions and couldn't find anything for 2016-17 from a cursory Google search.
This was all I found -
CAFC
And wasn't quite what I was looking for.
Yes, but I do think a win at trial and award helps to soften up the negotiating position of the cable cos. What jury isn't going to believe that Comcast and Friends didn't cheat these poor little inventors out of their licensing fees/royalties? There's no way a large jury award doesn't get a day or two of massive publicity as well - WSJ, WAPO, NYT - the PHILLY. That will create a lot of negative publicity for Comcast and others. Guess what- then State AGs reading headlines will renew looking at billing practices and cheating of customers. Expect another rash of consumer protection filings against cable cos.
Appeals are to be expected, but...
As the clock ticks down and past Oct 2020, Carter's position will also move closer to aligning at some numerical position X with the cable cos or modem makers.
Today's news was certainly way better than a poke in the eye with a sharp stick.
Yes, it doesn't sound like the EMA is going to pull Omacor in Q1'19 like Michael Yee was forecasting on his analyst news timeline based off the 12/14/18 EMA CHMP opinion. Maybe an EMA final decision will be in Q3'19?
- Its now being reported that an appeal request was filed with the CHMP to re-examine the post-MI indication.
- The request will stop the process and the EMA will have to seat a new rapporteur/co-rapporteur to the case to review old/new information.
- New CHMP opinion expected on the appeal in Q2'19.
KCSven: Estimize has been showing the following estimates:
Merry Christmas everyone!
John Lewis Christmas Ad 2018
(Big fan of the John Lewis ads every year - 2016's Buster the Boxer is my favorite!)
Tasty: I wondered about that myself. I saw last week the hedge funds' lobbying group just picked up Mark Epley, Paul Ryan's general counsel.
MFA
JFM: Prudhoe Bay in the 1980s that must've been quite the Arctic adventure - do you have any polar bear pix? The male to female ratio in Alaska is like 10:1. Was it 20:1 back in the 80's? ;-P
Ahh, the 80's. Save the Wave music! Boy, I wanted to see Duran Duran in concert so badly along with my friends in our parachute pants - we had Simon Le Bon posters on our walls and centerfolds in our pre-teen rags.
And in the 1980s we had a different kind of oil flowing than from Prudhoe Bay - from this 1989 JAOCS pay article:
- Super EPA 500 (Walgreen Labs, Inc) Ethyl Ester 500 mg EPA/DHA
- Nature's Pride EPA Pure 700 (Nature's Products Inc) FFA 583 mg EPA/DHA
- O-3 Pure Super 500 (Schiff Bio-Food Proc) Methyl Ester 500 mg EPA/DHA
Also, you'll see Dr. Von Schacky (in the US during 1985) using ethyl esters (and we know Japan had EPA EE - Nippon Oil & Fats, too, because of the timing of those Chiba field trials).
We had tons of newspaper articles on O-3 fatty acid supplementation for health. Oh wait. We still do.
Big oil and little oil --->
The Rappahanock Record in Virginia on Oct 5, 1989:
Zapata AND menhaden oil both on front page
George HW Bush started Zapata Corp as an oil and gas company in 1954, but he sold out in 1966. Also, looks like Zapata Corp vessels were used by CIA in Bay of Pigs. Eventually in the 1980s Zapata Corp bought Omega Protein. During the 1980s soybeans rose to prominence in the US...which started to take over the role in animal nutrition that menhaden had played. In the 1990's Avram Glazer took over Zapata via some shady deals & launched an Omega Protein IPO. Glazer used a front man named Theodore Roxford to pump the stock of Omega Protein so that Glazer could show enough collateral to buy more of Manchester United in 2003. In 2007 Roxford was convicted of securities fraud by the SEC in the SDNY. The Glazer billionaires had a teflon coating and the family still controls the Bucs and dishes the family office money via foundations in TB. Just another decade in America - same corrupt rigging as always.
Sources:
Zapata as CIA contractor for Bush
zapata debt problems
Glazer billionaires- Manchester United and the Tampa Bay Bucs
Roxford Zapata scheme prosecuted
$900,000 fine
Guess, I'm not the only Gen Xer who stills likes Duran Duran and 80s music-
Save a Prayer
STS: Absolutely on soy. It's everywhere. Did you see all the Cargill family members on the Forbes 400 list? There's a reason that family office is so wealthy.
Your second paragraph, yes. I don't know what Pharmacaps (Banner) has on file - maybe the records weren't written on acid free paper...
The other two things I've referenced where to find. As to my grandmother's fishoil - I don't know if EE - just that she took capsules and complained about the burps. She hated fish.
But, what about the Lovaza substantial research and when? Are we going with what definition of "published" - what does that mean then compared to now? Does the DS industry get held to a 2018 standard of published? Or to the 1994 standard that had more lag time? AMRN may be able to hammer pitons into these cracks for solid anchoring points.
I really don't think your last paragraph is going to be a long-term problem - ? More of what AMRN has in the near-term is a sales issue that CAN BE SOLVED by BP and/or time to keep releasing new study elements from R-it to give the new sales reps a chance to educate healthcare professionals with new findings.
The DS industry can play so loose that there NEEDS to be a clinical RX purity walled off by the FDA and a lot of PCP education. IMO, Omax and CoreOmega will lose if they don't settle.
Yes, thanks - I cut back on the Omegavia to 1g for now. Feeling better and am looking forward to back relief hopefully by giving it some time without all the nasty side effects of NSAIDS. Maybe it's like frontloading at home in my 20's before heading out clubbing only instead of alcohol now it's EPA.
Also, at the dentist today -- always ranked in Seattle Met magazine as a top one in the city -- that I had heard of the benefits of pro-resolvins from fishoils (I may have actually said EPA looks like the important fatty acid...) regenerating gum tissue in dentistry by Dr. Thomas Van Dyke, DDS at Harvard in rabbits and now humans and asked if he had? He said no, but he was really interested and asked me to print and mail him the study. Cool, huh? Except then he thought I was afraid I had periodontal disease and was at pains to say I was totally fine and had absolutely no issues. LOL. Guess I did too GOOD of a sales job. I'll mail him Reduce-It, too and he can connect the dots.
HDG: Thanks for the cool art links. I had not heard of Zoltan Kemeny before, but I do like the sand and gravel sculptures - some look like honeycombs or columnar basalt. A very masculine ethos but via the lens of openings...which is the positive and which is the negative space- interesting. The Maria Kilf and Patricia Kaliczka works look cool, too. I see Budapest is a 2 hour flight from say Brussels or Paris. I may have to visit Budapest (never been before) late this spring - I have a couple of trips to Europe in Q2 and can tack on an extra day or 2 before heading home. Will Budapest be drinking tea with jam by then?
Yes, you got it- that's exactly the bit - that section corresponds to FDA current guidance to industry - they've reaffirmed it. It's hard to say with your specific letter and I don't know all the background of the company (never heard of them), etc that you linked to from 2014, what was going on behind the scenes between the FDA and them. Maybe you have the background? Anyway, there may have been other problems and the FDA chose to "crack down" on that "synthetic" rationale since it was available. Kind of like Al Capone getting nailed for tax evasion. Without digging into it, I can't say, but given current guidance and my read of the political landscape that's why I hold my grey zone define by concentration level viewpoint as a way through the thicket. I am comfortable saying that as of today, the FDA has not changed its guidance to industry and couple that with the FDA moving at a glacial pace like most large organizations...
TOSCA's find of last week's DS working group announcement was interesting because the big trend right now like in my reindeer post with the videos and CO2 supercritical equipment on Saturday is CBD oil. I've heard that sales doubled last year and tripled from June on, of this year, with CBD oils for some apothecaries. It was the "HOT" trend at Supply Side West which means it will be at the European nutra and cosmetics trade shows, too. Because the FDA sits at the Federal level then it makes sense they are going to focus on enforcement because a lot of the growth is happening at the state level. So, here we have another grey area just like in the regulatory framework surrounding DSHEA, but with CBD its state vs federal legality. I've also heard that credit unions have been branching out specifically to handle marijuana monies now, too.
I was trying to think of another analogy to the fishoil apart from the apples. In the US I can buy McCormick's vanilla extract: made from synthetic vanillin, which used to be from the sulfite pulping process in wood pulp. Now, its made from petrochemicals or micro-organisms. Or if I want pure vanilla extract (defined between industry and the FDA as minimum 35% pure vanilla) then I can buy that as well. I could make it by mashing up the vanilla pods and adding ethanol and water. That's "pure" vanilla extract. Nobody has done this that I know of but I could start a marketing biotech company, hire out all the different business functions, list shares to fund the preclinical research, Phase 1,2,3 CTs and assuming statistically significant benefit was shown for a clinical condition- I'd have a new drug. The generic name might be vanillin ethyl. And I could trademark "OlfactaVAN" and say its used to treat HSDD.
That was just a quick one off the top of my head. We'd find with "OlfactaVAN" that we have a clinical purity level to treat a diseased patient population and we'd still have vanilla extract either "pure" or "synthetic" in the supermarket for regular consumption.
AMRN needs HOT sales and marketing of Vascepa and the expanded label will help in those regards.
**Did anyone else see in the news today that two former executives of Wilmington Trust were actually sentenced to jail for securities fraud? Appeals pending though, but of course.
Afish: I think so too regarding STRENGTH and the regulators. Your estimate and Tasty's at 8% +/- a few percentage points of benefit match others. Thanks for the arthritis article out of AU - I learned a few new things so I'll keep as a reference.
Vu: Thanks - yes. I'm going to give it another 2 months, but now lower at only 1g/day, & maybe up to 1.5g. Last night I went with .5g for an evening dose and this morning that tight fluttering feeling is gone.
TOSCA: Thank-you for that find this past week regarding a new FDA working group for DS (long overdue for new guidance).
XBL: Good clarification for me, too. I also always thought mutual fund managers used % gain when cashing out their positions. So a daily basis pegged to a respective index. Your post #145998 - what's your latest take - will AMRN be in the Russell 2000 in June then or still do you forecast Russell 1000?
Right, 2014. All industry sectors have to evolve with constant negotiations between the agencies and courts.
2016 was the last unoffical guidance.
And we have more coming soon that will be a complete snooze on the PPS except for a few days, if that. Unless a BO or partnership gets announced the same week. LOL. <fingers crossed>
-SK
HDG: I already linked to the latest FDA guidance from 2016. Looks like your quote links back to Ihub 2014 on the FDA B&W idea. It's a continual and ever changing political process for sure.
Esterify = pour alcohol into a fat to push a reaction so you can distill it.
Also, I used the apple sauce example specifically because there is a chemical reaction I just used common words. Lemon juice is citric acid. Just as alcohol would be a chemical reaction if I wanted to crack the "synthetic" octadecenoic acid EE out from the bacon fat.
My reindeer post today covered this - from examples one can see with the distillation of the marijuana oils (fish don't have the terpenes like plants do though).
A combination of processing steps can be patented...if its not in the prior art already. Unfortunately, you don't think there's much on the patent front.
Kiwi- just wanted to see if it would work as an analgesic for arthritis in my LBP. I think the dose may be too high at 2g/day? Ibuprofen/Naproxen works, but they upset my stomach and actually I ended up just after college in the ER because a doc had put me on fluoro ibuprofen for an excruciatingly bad muscle tear and it messed up my GI - I couldn't stop vomiting for 3 days straight. I never had stomach issues prior to that and ever since I have had a weak stomach.
It is still a supplement, so I thought why not try something that is natural and seemingly well-tolerated as an anti-inflammatory.
STS: Yes, I read it - you well stated your case and I appreciated it. And you may be right.
STS, I simply think there is stickiness around the policy, industries involved and political bigwigs. This is my read on it. We don't have to agree 100% of the time do we? I mean, we're mostly pretty much in alignment on our opinions like what 95% of the time?
Practically all our foods would then be drugs is how I view it.
Soy protein isolate for example - it's everywhere you look...all the hydrolysates... etc etc. Are the artificial meats grown in labs synthetic? I think so, but to say each new tofurkey burger needs a NDI?
I'm still OK in my opinion here that this is a grey area for supplements on the market prior to Oct 1994.
I reviewed Pg 13, Section IV as below:
FDA non-binding draft guidance Aug 2016
The evidence is there in the microfilm from newspapers of that era. I mentioned a company name even who was producing. I think today's version of that 1980's company is Patheon, currently an API encapsulator for AMRN if I'm remembering my read of a 2018 10Q. My grandmother was a nurse and took menhaden EE supplements in the 1980's because she was reading the Berkeley Wellness Newsletters (some others too, but that's the only one I remember in addition to her medical books because I was a kid I didn't pay all that much attention).
Companies like to experiment and put new products out to get an edge on the next company over...what can I say? Time didn't stand still in the 80's and 90's any more than it does today.
Vu/North: I've had reindeer sausage for breakfast in Alaska. I liked it.
I hope Rudolph doesn't do a fly-by tonight. Hopefully, he's busy working out up at the North Pole for the big event.
Tasha: Touche.
Tasha: No, the OmegaVia 500 or whatever its called.
EGADS! Don't tell me they laced it with ephedra!! Is the supplements industry on Santa's naughty list?
Tasty mentioned his gf had a similar experience so I was glad he posted it because at first I was thinking it was my asthma starting up out of the blue which it shouldn't be (no triggers). It's a weird feeling and I don't like it.
And by the way your darn NEPT historical post is what got me on that whole MJ oil tangent! I'm wondering about the properties of that oil now! J/K
Oils are really cool science though. Fun to make a kitchen the laboratory that it really is. Check out the late Paul Allen's Intellectual Ventures kitchen experiments (there's a series of books too) over in Bellevue.
Amazing!
IV kitchen lab
Thanks HDG. Yes, that's about all I was saying since so many people on the board view it as another binary event, albeit with an unannounced date.
1) Agree the FDA needs to clear up the grey area - especially after R-It results. I was only suggesting a possible way negotiations could happen given my readings and the unlikelihood of the FDA strangling an entire industry that is substantial to Utah's economy.
I could list more than a few examples, but here's a recent ripped from the headlines one. For those unfamiliar with the Jones Act it requires that vessels be built & owned in the US if they are going to operate in the US. But, there are a few rules like under 7.5% foreign steel can be used and a shipbuilder and owner would be OK. The Coast Guard oversees the Jones Act. So, what happens when somebody goes over? Would the USCG have the final say - or would it be politically negotiated behind the scenes and then presented as a done deal on such-and-such a date?
Trump signs Jones Act waiver
There's a technical reading of the law and then there's real world law mixed with politics.
2) Yes, thanks I've been meaning to ask the board or lowlevel what actual patents exist to date on process? Ok, well noted (sadly) that you think there aren't any.
I read one of their patents with a 2017 date? and it did list EPA concentration levels so that's why I connected it that way (but I also have seen krill patents and Pronova patents and they all use the same boilerplate language)...I don't have the time or inclination to cull through all their patents. The marketing angle alone is going to be so tough...
3) Totally agree - Smarterer and I actually discussed this scenario. Let's say AMRN gets a Christmas or New Year's wish. CAFC remands back to ITC. ITC conducts a quick investigation. They find all DS imports are illegal. At that point - I agree with the current US based refining capacity that AMRN would need in X # of years out then the FDA would have to quickly approve some of these smaller refiners. Smarterer had seen instances of government quickly approving in these types of situations which I had also just logically figured - every human organization is political. A few shortage headlines like we've seen with "flu vaccine" and the FDA would spring into action.
4) I personally think O-3s DS are legal. I view them as an entirely different part of the market. Maybe they don't provide much by way of huge benefits - but neither does drinking Coke or eating a Big Mac. That doesn't make them illegal.
Do I think docs or PBMs should tie them to the equivalency of a clinical trial result at a guaranteed clinical efficacy level of purity like Vascepa or in 10 years a generic V? Of course not. As Ziploc said - this is what makes it a legal drug in my view that has been walled off-- by the CTs and FDA NDA approval.
My other reindeer post today - is a visual on "esterification." Mix some alcohol (the non-polar solvent) in the fishoil to pull off the glycerol backbone from the fatty acids.
If I cut up an apple so that it stacked neatly to fit into my daughter's lunch container or better yet, made homemade apple sauce and put some lemon juice in it so that it didn't lose its color, ie oxidize, and then Vitamixed it with some probiotics...that doesn't mean the apple sauce is now a "drug." It's still a food.
I'd have to file for some element of the apple sauce and prove that the compound had a SS benefit, right? I mean, that's the idea behind protection against apothecary quacks of yesteryear.
Some zipped photos and a small video on kitchen esterification -
oil and alcohol
You'll see in one photo 3 small cups with crude fish oil - that have been in the fridge for different amounts of time. The middle and right hand cup are showing cloudiness (crystals are forming for the fatty acids as the temperature drops - use can use these crystals as a processing method to separate, too). The right hand bottle has been in a freezer - it's solidifying. The reddish color is from the krill the fish have been feeding on. You can use bleaching clay, for example, to remove the color - then to our eyes it's a marketing way to say "it's pure" kind of like Dasani water bottles from Coca Cola have that "pzzzt" sound when you open them from using some CO2.
These are signals to our senses that its pure (special). The small video takes some rum, a non-polar solvent (alcohol), to start pushing the esterification reaction of taking the fatty acids from their glycerol backbone and putting an ester in its backbone position instead.
If you have a counter-top water distiller then you could distill the Rum back from the now esterified oil. Or if you wanted to mix and match and you had a small vacuum pump you could separate the bigger molecules and then distill the fishoil to begin "concentrating" the oil. Yes, it's "synthetic." So are rum spiced apple pies I bake. Are they proven to a clinical level of efficacy to cure anything? No, I'd have to run a clinical trial to prove that my apple pies cured missing Mom's homecooking.
You can also try this at home by frying up some bacon. Take the lard or warm oils left after frying and mix with the highest proof alcohol in your liquor cabinet...
JMO - we'll see how it all plays out while waiting for a likely BO. If we knew all the answers ahead of time it wouldn't be half as interesting. So you have an art gallery! How cool. We enjoyed visiting the Peggy Guggenheim Art Collection in Venice last year - some niche and not as well known modern art but by well-known artists. I highly recommend it.
STS: Definitely how much is the key. I've been lately thinking maybe its a little bit of both though - how much and how quickly (no use if it passes through your system unavailable and its 10g, but that's an extreme example I know). But, yeah, I get the argument that bio-availability is selling new technology. Like all the menu and laptop tech in cars...We do like our tech in America.
So, I've been on the 2g/daily now for 3 weeks of EPA. I've experienced a very slight reduction in my back inflammation (as lessening in stiffness sensation and no actual pain-pain). But, I've also noticed weird feelings - like heavy flutters in my chest and then like a tight pain at my heart. At times - very - uncomfortable. It goes away and I try to practice more on exhale breathing, etc. But, I've been thinking to cut down on my self-experiment to 1g/daily to see if the weird flutters go away.
Middle age. It happens!
Relocated/CBB: Very interesting. Our board Chief Medical Science Officer and the entire panel of our resident docs might be better placed to answer that.
My guess - forget genetic differences in all of us, forget differences in diet and chronic/acute conditions, forget differences in our gut micro-biome, is that if only looking at the types of fatty acids we consume there very well could be differences in bio-availability. The fatty acid molecule sizes and shapes are different...
I hope everyone realizes how absolutely cutting edge "bio-availability" questions and discussions are. This board takes it to a level really only seen by top shelf researchers ---many of those here on Ihub whether by education or training or their own research are all equally impressive.
I mean that as an utmost compliment.
Reindeer and fatty acids for the holidays
Reindeer, when not in Santa’s corral, live in the tundra where they mostly eat a lot of non-nutritious lichens and some grasses. I googled it and coincidentally lichens have a lot of PUFAs especially AA and it acts as an anti-freeze for them by enhancing their cell permeability.
Arachidonic acid melting point: -56.2F
Reindeer, like a lot of North Atlantic fish species & offshore oil drilling, have been extensively studied in Norway. While all mammal legs & bone marrow change their lipid type by location, in arctic mammals it’s more extreme. Higher on the leg there are a lot more of the saturated fatty acids like stearic (#2 most common saturated fatty acid in nature after palmitic) then lower there are more monounsaturated fatty acids like oleic, with lower temperature melting points, closer to their hooves so that the lipids stays gel or fluid-like even in the snow.
Stearic acid melting point: 156.7F
Oleic acid melting point: 55-57F
reindeer physiology pg 278-279
This ability to stay liquid has been used for centuries to make neatsfoot oil by rendering the legs and hooves of ruminants.
Here’s a partial list of fatty acids found in US menhaden fish oil.
For Vascepa it’s only about the EPA – every other smaller or bigger molecule has got to go. Notice how close AA and EPA are to one another?
AA (20:4n3) has only one less hydrogen double bond on its carbon chain
than EPA (20:5n3).
EPA melting point: -65.2F (only a 9 degree difference from AA).
Their molecular weights are similar, too.
AA weighs 304.4669 g/mol. EPA weighs 302.451 g/mol. AA & EPA are like conjoined twins.
Why does all this matter when it comes to fracking EPA from fishoil?
Although there are several different ways to crack or fractionate (separate) different fatty acids when you have conjoined twins – the operation to separate the two is trickier. It’s hard when looking at big tanks and pipes to “see” what is going on inside because the reactions are hidden. Plus, refiners like to keep their latest advancements in processing technology secret.
However, enthusiastic cannabinoid oil home & micro brewers provide a partial glimpse into how a crude fishoil gets refined and purified --
These goofy guys waiting to get baked show short path distillation for various oil fractions with large boiling point differences being separated:
3 O-chem dudes
Apeks Supercritical CO2 systems in Ohio – Ethanol (Esterification) + Winterization (2nd step after supercritical CO2 extraction of raw material completed in their particular process)
Tasty: So much awesome sauce. Luvin' it.
I'm working on a nerdy reindeer post...'tis the season to geek out after all
Tasty: I think all of Brussels is a joke. The city is dirty, the people tend to be rude and arrogant. The French have a laundry list of Belgian jokes - doesn't that say it all? (begins with all their nuke powered highway lights and about their child abusers).
Bruges is nice though.
Brussels is very into bio-availability and hydrocarbon related things these days.
The US sometimes follows and other times we go our own way.
STS: I've complained several times before about Brussels...they suck.
In Oct I did post about the UNFAO-WHO meeting that was held at the end of Nov. in Germany. And I didn't think anyone was interested in hearing about what they decided (granted its hard for folks to connect all the dots, but now unfortunately they are being connected), but yeah they decided to wait in Germany and not adopt any references on O-3 daily allowances. So, I'm not surprised by the EMA determination - kind of follows along lockstep from the latter.
30,000+ O-3 studies and its become too trippy for docs and regulators to make heads or tails of any of it and so they "err" on the side of caution.
And then imagine if they allow Cochrane to be the final voice for practicing clinicians with their meta-analyses ready made to be inserted into decision trees??
Can you start to see the scale of the challenge?
STS: Thanks, I feel I'm good though on both my outside cold case historical research and pertinent case law readings. And you know I'm happy to deep dive into research and waste hours on this stuff as much as you!
I know documentation has been provided showing DS in the EE format from the 1980's (went through and looked at Reedville, VA all the way back to whaling history from the founder coming down from Maine and how he took knowledge from processing the wax esters from whale oil, etc regarding the prior art). I've taken the time to cut and paste NOAA covers and repeatedly reference the researchers who were working back in the 1980s to this board. Finding one word or line item in the documentary record versus the body of precedence going back decades would be quite the twist - I'm doubtful there is a single smoking gun, but good for those who think they've found it. I would see it more as threading the needle - or somehow trying to build on where things have been as I said before.
The FDA by its own admission has NOT provided final guidance into the three terms I put in bold last night (pre-clinical is not substantial or else you'd not be able to use the GRAS substances in question in food, which you certainly can). I provided the publish dates (unlike now - Lovaza's trial may have been written up, but not published publicly because it didn't happen overnight in the 90's - so what do you do with that grey area?) How many times has this board itself pointed out the safety profile of EPA EE? There's a reason for that.
I like the passion of everybody on this board as brand evangelizers (it's awesome!), but once in awhile it does remind me of Timothy Treadwell...
Onerag: A beer sometime? And we'd debate the Red Sox or Yankees - and you'd crush me in a second.
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DSHEA defines which dietary ingredients can be used in supplements. It specifies that concentrates of dietary ingredients are within the definition of a dietary supplement.
According to Section 3 of the Act, the term "dietary supplement" means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
a) a vitamin
b) a mineral
c) an herb or other botanical
d) an amino acid
e) a dietary supplement used by man to supplement the diet by increasing the total dietary intake; or
f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).
VuBru: Yes, agree. It's a tiny bit similar to the Qualcomm and Apple dispute at the ITC which by the way the ITC is now deciding to review its FID --that no exclusion order on Apple Iphones be issued because it would not be in the public interest. See the news in the last 24 hours. I think that case is substantially different in that its primarily about the chip patents and seems more straightforward on the surface.
With AMRN - ITC : it's about pushing the FDA to action. And it's always easier to pull which is why I wondered if stuff going on behind closed doors to carve out the market which could explain the overly long delay in the appeal.
Onerag: I'm primarily looking at this from the perspective of what this does to AMRN's market and thus does it even impact investor sentiment.
I'm not trying to parse the words "shall" and "must" for what an administrative agency has to do according to an ALJ or the CAFC. The IP attorneys will care about that - investors likely will not except as it pertains to walling off some marketshare %.
Zip - yes, I agree. Except I would add that the FDA is partially prevented from doing their job by DSHEA.
So, as I've stated before we can thank Orrin Hatch for DSHEA, Republican from Utah for protecting all the DS jobs in his home state.
And now the mantle has been passed to Sen. Romney.
And supposing a win, in whatever form, don't you think the defendants will immediately file with SCOTUS?
2019 is looking uneventful for AMRN, yeah - except for the other potential catalysts.