Marijuana Stocks Drop as McConnell Slams Measures to Aid Purchases

 Marijuana stocks plunged after Senate Minority Leader Mitch McConnell criticized Democrats Tuesday for pushing to include measures to make it easier to buy pot in an end of year spending bill before Republicans take hold of the chamber.

The Cannabis Index, which includes major pot players like Canopy Growth Corp. and Tilray Brands Inc., fell as much as 10% on Tuesday, the most intraday in two months.

Many banks and credit card companies prohibit customers from purchasing cannabis through them while the drug is still federally outlawed. The SAFE Banking Act, which some Democrats have pushed to include in year-end legislation, would prohibit federal banking regulators from penalizing institutions that provide banking services to dispensaries.

McConnell said on the Senate floor Tuesday that the Democratic efforts to include “pet priorities” in the so-called defense bill would make the banking system “more sympathetic to illegal drugs.”

Cowen analyst Jaret Seiberg said they still see the banking bill as “likely to be added to the year-end omnibus,” even if its kept out of the defense bill.

https://www.yahoo.com/now/marijuana-stocks-drop-mcconnell-slams-191428446.html

Kymera cut to Neutral from Outperform by Credit Suisse

 Target to $32 from $47

https://finviz.com/quote.ashx?t=KYMR&p=d

Celldex: Positive Data from Barzolvolimab Phase 1b Study in Urticaria

 - 100% complete response rate in cold urticaria after single dose of barzolvolimab at 1.5 mg/kg, including in omalizumab refractory patients -

- Long term follow up of patients with chronic inducible urticaria treated at 3.0 mg/kg confirm that barzolvolimab-induced responses and mast cell suppression are durable and linked -
- Company to host webcast conference call on Tuesday, December 6 at 8:00 a.m. ET -

  
Webcast and Conference Call
The Company will host a conference call/webcast to discuss the results today at 8:00 a.m. ET. The event will be webcast live and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (800) 715-9871 (within the United States) or (646) 307-1963 (outside the United States). The conference ID is 4307990.

https://www.biospace.com/article/releases/celldex-therapeutics-presents-positive-data-from-barzolvolimab-phase-1b-study-in-chronic-inducible-urticaria-at-global-urticaria-forum-2022/

‘Constant turmoil’ at FDA’s food regulatory agency, report says

 The Food and Drug Administration’s Human Foods Program lacks leadership and mission clarity, leading to slow decision-making and weak regulation of foodborne illness, according to a highly-anticipated, independent report on the FDA’s Human Foods Program.

The FDA commissioned an independent expert panel to review the Human Foods Program in July 2022, in part due to the ongoing infant formula crisis, which critics say demonstrated the agency’s pattern of slow responses. The formula crisis included nationwide shortages sparked by a key Abbott plant in Michigan shutting down and issuing a recall, after FDA inspectors belatedly detected strains of a bacteria at the facility that can be deadly to babies.

The investigation was led by Jane Henney, former FDA commissioner, and conducted by the Reagan-Udall Foundation, which receives funding from the FDA, industry and private donations. A separate commissioner-mandated review will recommend changes to the FDA’s tobacco program by Dec. 19.

In response to the report, the FDA said in a statement that it plans to release a public update on the “new vision” in January 2023 and any changes to leadership as well as internal process and procedures by February 2023. The “new vision and structure” will be based on the RUF report, the internal review of the FDA’s response to the infant formula crisis as well as new advances in food science.

FDA Commissioner Robert Califf called the Human Foods Program a “top priority” for the agency in a statement.

The “current culture” in the Human Foods Program is “inhibiting” the agency from protecting public health, the report says.

“The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration,” write the report’s authors, who include former agency staff and scientists. The FDA relies too much on “consensus” which can lead to “unacceptably slow” decision-making times.

https://news.yahoo.com/constant-turmoil-fda-food-regulatory-193915572.html

Employers Use Patient Assistance Programs to Offset Their Own Costs

 Anna Sutton was shocked when she received a letter from her husband's job-based health plan stating that Humira, an expensive drug used to treat her daughter's juvenile arthritis, was now on a long list of medications considered "nonessential benefits."

The July 2021 letter said the family could either participate in a new effort overseen by a company called  SaveOnSP  and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

"It really gave us no choice," said Sutton, of Woodinville, Washington. She added that "every single FDA-approved medication for juvenile arthritis" was on the list of nonessential benefits.

Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers' spending on insurance — which, they say, could be the difference between an employer offering coverage to workers or not.

It's the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term "nonessential" stresses patients out even though it doesn't mean the drugs — often called "specialty" drugs because of their high prices or the way they are made — are unnecessary.

Some advocates fear the new strategies could be "a way to weed out those with costly health care needs," said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs, Klein said.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers' pharmacy benefit managers, such as  Express Scripts/Cigna , to implement the strategy. There are also smaller vendors, like  SHARx  and  Payer Matrix , some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as "nonessential," which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a  lawsuit filed in May  by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, New York.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don't bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

"We're seeing it in every state at this point," said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Illinois, a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed — and sometimes unexpected bills for consumers.

"We have patients get billed after they max out their assistance," said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error, she said.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tennessee, whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug's cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient's out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

"Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can't meet the copay," said Harry Sandick, a lawyer representing J&J.

J&J's lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are "coerced" into participating in copay assistance programs after their drugs are deemed "nonessential" and therefore are "no longer subject to the ACA's annual out-of-pocket maximum."

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients' deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such "alternative funding programs."

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be "underinsured" so they won't be affected by the foundation's decision.

In a statement, SaveOnSP said that employers object to drug companies' "using their employees' ongoing need for these drugs as an excuse to keep hiking the drugs' prices" and that the firm simply "advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees."

In  a court filing , SaveOnSP said drugmakers have another option if they don't like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Sutton's part, her family did participate in the program offered through her husband's work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, "the whole process seems kind of slimy to me," she said. "The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other."

https://www.medscape.com/viewarticle/985102

CV Benefits for Some Antioxidant Supplements

 A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients — including omega-3 fatty acids, folic acid, and coenzyme Q10 — may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, and selenium; and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the December 13 issue of the Journal of the American College of Cardiology (JACC), and was published online December 5.

"Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients," the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

"Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects," senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, Rhode Island, said in an American College of Cardiology press release.

"The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits," the authors add.

Experts Cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women's Hospital, Boston, Massachusetts, told theheart.org | Medscape Cardiology that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven't been well replicated.

"Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely," she noted.

"The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events," Manson said. "Also, with trials of this nature, the potential for publication bias warrants consideration because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication."   

However, she added, "Despite these limitations, this is an important contribution to the literature on micronutrients and health — and goes a long way in separating the wheat from the chaff."

Also commenting for theheart.org | Medscape Cardiology, Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

"This study does not make sense. Some of the 'micronutrients' in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial," he said.

Nissen added that many of the included studies are low in quality. "I must quote [renowned cardiologist Dr] Franz Messerli: 'A meta-analysis is like making bouillabaisse," he said. "One rotten fish can spoil the broth.' This type of analysis does not override high-quality, large, randomized trials."

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium, and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

"To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns," they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had "moderate-to high-quality evidence" for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

"The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors," the authors say.

"The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally," they conclude.

Commenting on some of the specific beneficial findings, Manson said: "I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation."

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation compared with placebo, "so the reported stroke benefit would need further confirmation."

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: "Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity."

The editorialists note that from a research point of view, "although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence."

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

"Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects," they conclude.

This work was partly supported by the United States' Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor.

https://www.medscape.com/viewarticle/985075

DOJ sending federal election monitors to just 4 Georgia counties for runoff

 The Justice Department said Tuesday that it was sending federal election monitors to voting sites in four Georgia counties for Tuesday’s Senate runoff: Cobb County, Fulton County, Gwinnett County and Macon-Bibb County.

The practice of DOJ organizing federal monitors at election sites traces back to the 1965 passage of the Voting Rights Act. The monitors include personnel from the DOJ’s Civil Rights Division and from its US Attorneys’ Offices.

https://edition.cnn.com/webview/politics/live-news/georgia-senate-race-results-12-06-22/index.html