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Friday, February 1, 2019

Typhus Epidemic Worsens in LA

A veteran Los Angeles City Hall official is one of the latest victims of an epidemic of the infectious disease typhus that continues to worsen across LA County.
For months, LA County public health officials have said typhus is mainly hitting the homeless population.
But Deputy City Attorney Liz Greenwood, a veteran prosecutor, tells NBC4 she was diagnosed with typhus in November, after experiencing high fevers and excruciating headaches.
“It felt like somebody was driving railroad stakes through my eyes and out the back of my neck,” Greenwood told the I-Team. “Who gets typhus? It’s a medieval disease that’s caused by trash.”

Rats Could Be Causing Typhus Outbreak in Los Angeles

[LA] Rats Could Be Causing Typhus Outbreak in Los Angeles
Armies of rats running through the streets of downtown Los Angeles are the suspected cause of a Typhus outbreak hitting the city. NBC4 I-Team’s Joel Grover reports for NBC4 News at 11 p.m. on Oct. 9, 2018.
(Published Wednesday, Oct. 10, 2018)
Greenwood believes she contracted typhus from fleas in her office at City Hall East. Fleas often live on rats, which congregate in the many heaps of trash that are visible across the city of LA, and are a breeding ground for typhus.
“There are rats in City Hall and City Hall East,” Greenwood added. “There are enormous rats and their tails are as long as their bodies.”

Last year set a new record for the number of typhus cases — 124 in LA County for the year, according to the California Department of Public Health.
Last October, Mayor Garcetti vowed to clean up piles of garbage throughout the city to combat the typhus epidemic.
The Mayor allocated millions of dollars to increase clean-ups of streets in the Skid Row area, known lately as “the typhus zone.”

Typhus Outbreak in L.A.: 5 Things to Know

[LA] Typhus Outbreak in L.A.: 5 Things to Know
There is an outbreak of typhus near downtown L.A. Here are five things to know about the disease.
(Published Wednesday, Oct. 10, 2018)
But four months later, the I-Team documented huge piles of garbage just outside the “typhus zone.”
“You can’t solve it (the typhus epidemic) until you hit the cause,” says Estela Lopez of the Downtown Industrial Business Improvement District, “and the cause of it is that you still have these mountains of trash.”
Added Greenwood: “This is a terrible illness and I wouldn’t wish this on anybody. But it’s not just homeless folks getting it.”

She believes the city should fumigate City Hall and City Hall East to protect the thousands of workers and visitors who could be at risk from getting typhus.
Responding to complaints from other city workers fearful of getting typhus, LA has already fumigated LAPD’s Central Division office and parts of the LAPD’s main headquarters.
Garcetti’s office did not respond to NBC4’s questions about why the city hasn’t fully fumigated City Hall buildings as well.

Increased Effort to Stop Typhus Outbreak in LA County

[LA] Increased Effort to Stop Typhus Outbreak in LA County
A typhus outbreak across LA County is creating a lot of concern. John Cádiz Klemack reports for NBC4 News at 6 p.m. on Oct. 9, 2018.
(Published Tuesday, Oct. 9, 2018)
Greenwood says she doesn’t want to return to work at City Hall East until the entire building is fumigated for typhus-carrying fleas.
“I am concerned about going back to work and getting this again, because I thought I was going to die,” Greenwood said.
Statement from Mayor Garcetti’s Office:

“Last fall we directed multiple City departments to begin a coordinated and comprehensive effort to improve cleanliness and protect public health in the Civic Center, including City Hall and City Hall East. In addition to increased trash collection and cleanings, aggressive action has been taken to address pests both in the buildings and in the surrounding outside areas — including abatement treatments and the filling of 60 rodent burrows and 114 tree wells. This work in busy and highly populated public buildings is executed carefully to protect workers and visitors, and the scheduling of extermination activities takes these factors into consideration.” — Vicki Curry, spokeswoman, city of Los Angeles

Cigna reports strong Q4, shrugs off potential impact of drug rebate plan

Insurance giant Cigna posted strong year-end results following its merger with Express Scripts.
Cigna pulled in $49 billion in revenue for the year, a 15% increase over 2017. Its income from operations was $3.6 billion or $14.22 a share, up more than 30% over $2.7 billion, or $8.77 a share, in 2017.
While the year-end results did not meet analysts expectations, Cigna reported a strong fourth quarter with $14.3 billion in revenue for the quarter ending Dec. 31, up more than 35% compared to revenue of $10.6 billion in the same quarter of 2017.
The insurer reported earnings of $647 million, or $2.46 a share in the fourth quarter, up 33% from $483 million, or $1.83 a share in the fourth quarter of 2017. Revenue, customer, and earnings growth were driven by continued innovation across the business, said David Cordani, president and chief executive officer, in a statement: “We enter 2019 further strengthened by our combination with Express Scripts and positioned to deliver outstanding growth fueled by accelerated innovation that will improve whole person health and affordability for customers and clients.”
 
In December, Cigna officially absorbed one of the largest pharmacy benefit managers in the country with its $67 billion purchase of Express Scripts. However, these fourth-quarter earnings come just a day after HHS announced a plan to eliminate drug rebates to pharmacy benefit managers to instead require them to be passed on to consumers, in what’s expected to be a hit to the industry.
The Trump administration said it plans to eliminate safe harbor protections for drug rebates negotiated by pharmacy benefit managers. Department of Health and Human Services Secretary Alex Azar said in a statement that eliminating the safe harbors would increase transparency in the black box of the pharmacy supply chain.
When asked about the proposed rebate rule, Cordani shrugged it off, saying it would “not have a meaningful impact on our growth or earnings trajectory” and said they are not considering it a “headwind” in 2019.
“The proposed rule, as it will be evaluated over the next 60 days, applies to Medicare Advantage and PDP. The mechanisms that exist in terms of the way rates are built up for Medicare Advantage, PDP, largely by design, flow and respect the rebates and pass-through the way the rates are built so we don’t see a major implication to that business portfolio,” Cordani said.
It does not apply to the commercial marketplace, Cordani said in regards to a question about whether the rule was expected to have a broader impact or potentially create a two-tiered system.
He did say Cigna sees some opportunities in the proposed rule.
“For example, it provides a mechanism to even further accelerate value-based care programs with the pharmaceutical manufacturers,” Cordani said. “You recall from the day we announced our proposed combination on March 8, we talked about how that is an important initiative that we passionately believe in. This will provide some accelerant to that. … But big picture, we do not see it having a material effect on the business portfolios as configured and are on track to deliver the 17% to 20% EPS growth in 2019.”
However, being the first insurer-PBM to hold an earnings call since HHS announced the proposed rule, Cigna faced several additional questions about its potential impact.
About 95% of all discounts and rebates within Express Scripts portfolio pass through and are shared and about half of all clients opt for full pass-through rebate relationships, Cordani said. That equates to about two-thirds the volumes and Express Scripts retains about $400 million before taxes.
“Those tools and levers continue to evolve, and you’ll see us continue to move away from trying to maximize a single lever as opposed to maximizing the overall value which is total cost and total quality as we go forward,” Cordani said.

Big At-Home DNA Testing Firm Secretly Sharing Data With FBI

Just one week ago, we warned that the government — helped by Congress (which adopted legislation allowing police to collect and test DNA immediately following arrests), President Trump (who signed the Rapid DNA Act into law), the courts (which have ruled that police can routinely take DNA samples from people who are arrested but not yet convicted of a crime), and local police agencies (which are chomping at the bit to acquire this new crime-fighting gadget) — was embarking on a diabolical campaign to create a nation of suspects predicated on a massive national DNA database.
As it turns out we were right, but we forgot one key spoke of the government’s campaign to collect genetic information from as many individuals as possible: “innocent”, commercial companies, who not only collect DNA from willing clients, but are also paid for it.

FamilyTreeDNA, one of the pioneers of the growing market for “at home”, consumer genetic testing, confirmed a report from BuzzFeed that it has quietly granted the Federal Bureau of Investigation access to its vast trove of nearly 2 million genetic profiles.
While concerns about unrestricted access to genetic information gathered by testing companies had swelled since April, when police used a genealogy website to ensnare a suspect in the decades-old case of the Golden State Killer, that site, GEDmatch, was open-source, meaning police were able to upload crime-scene DNA data to the site without permission. However, the latest arrangement marks the first time a commercial testing company has voluntarily given law enforcement access to user data.
Worse, it did so secretly, without obtaining prior permission from its users.
The move is of significant concern to much more than just privacy-minded FamilyTreeDNA customers. As Bloomberg notes, one person sharing genetic information also exposes those to whom they are closely related. That’s how police caught the alleged Golden State Killer. And here is a stunning statistics – according to a 2018 study, only 2% of the population needs to have done a DNA test for virtually everyone’s genetic information to be represented in that data.
Thanks to its millions of customers, FamilyTreeDNA’s “cooperation” with the FBI more than doubles the amount of genetic data law enforcement already had access to through GEDmatch. According to BuzzFeed, and as confirmed by the company, on a case-by-case basis the company has agreed to test DNA samples for the FBI and upload profiles to its database, allowing law enforcement to see familial matches to crime-scene samples.
There is one caveat: FamilyTreeDNA said law enforcement may not freely browse genetic data but rather has access only to the same information any user might. Which of course, is ridiculous when the FBI has the same access as every single user.
Needless to say, the genealogy community has expressed dismay.
Last summer, FamilyTree DNA was among a list of consumer genetic testing companies that agreed to a suite of voluntary privacy guidelines, but as of Friday morning, it had been crossed off the list after it was revealed that the company had been lying all along.
“The deal between FamilyTreeDNA and the FBI is deeply flawed,” said John Verdi, vice president of policy at the Future of Privacy Forum, which maintains the list. “It’s out of line with industry best practices, it’s out of line with what leaders in the space do and it’s out of line with consumer expectations.”
Some in the field have begun arguing that a universal, government-controlled database may be better for privacy than allowing law enforcement to gain access to consumer information: after all what’s the difference if the companies will simply hand over all the information secretly. At least this was the public will know that Uncle Sam – and who knows who else – will have access to one’s genetic code.
FamilyTreeDNA said its lab has received “less than 10 samples” from the FBI. It also said it has worked with state and city police agencies in addition to the FBI to resolve cold cases.
“The genealogy community, their privacy and confidentiality has always been our top priority,” the company said – supposedly with a straight face – in an email response to questions submitted by Bloomberg.
And why would it tell the truth: just like search engines and social networks, where the user is the product, and all the information about the user is carefully collected, isolated and stored, then sold to the highest bidder, or quietly handed over to the government, consumer DNA testing has become a giant business: Ancestry.com and 23andMe Inc. alone have sold more than 15 million DNA kits. Concerns about an industry commitment to privacy could hamper the industry’s rapid growth.
To be sure, there are some fringe benefits – like authorities actually doing what they said they would do – since the arrest of the suspected Golden State Killer, more than a dozen other suspects have been apprehended using GEDmatch. By doubling the amount of data law enforcement have access to, those numbers are likely to rise. But at what cost?
“The real risk is not exposure of info but that an innocent person could be swept up in a criminal investigation because his or her cousin has taken a DNA test,’’ said Debbie Kennett, a British genealogist and author. “On the other hand, the more people in the databases and the closer the matches, the less chance there is that people will make mistakes.’’
And, of course, if every person’s DNA is in one giant genetic database, there would be no mistakes. Now if only the risk of abuse of this information was also nil, then everything would be great. Alas, as Snowden revealed when he exposed the flagrant abuses at the NSA years ago, this will never be the case especially when the “objective and impartial” FBI is involved.

Aphria rises after Citron sells, MedMen sued by former CFO

Short seller Andrew Left said early Friday he was exiting his position in Canadian cannabis producer Aphria Inc. and had begun to short Cronos Group Inc., citing its high valuation relative to analyst price targets.
Left’s Citron Research said Dec. 18 that it expected Aphria shares to climb to $8by the end of 2018, and in a Friday tweet said the stock had gained more than 60%. In the December report Citron said it expected Aphria to gain 40% by the end of last year. Aphria APHA, +0.73% APHA, +10.34%  stock closed up 10% Friday, and has gained more than 80% since Citron made its call. Aphria said Friday that it has transferred plant cuttings from four weed straings to Denmark-based Schroll Medical. Aphria will now be one of the first pot growers to produce its own pot in Europe.
Citron did not return a request for comment.
In the same tweet, Citron said that it was short Cronos CRON, +1.06%CRON, +6.06%  because the stock was trading 70% above sell-side analyst estimates. According to FactSet, there are seven analysts covering the name, with an average target price of $17.61. Including Friday’s rise of 5.7%, Cronos is trading roughly 55% above the average target price, according to FactSet.

Cronos stock rose 60% since it announced the $1.8 billion investment in the company by Marlboro-maker Altria Group Inc. MO, -0.30%  Thursday, Altria’s CEO said he expects the global cannabis market to reach $40 billion in 10 years with no new cannabis legalization laws, and $250 billion if pot were legal the world over. He said the company wasn’t planning to stop at Cronos when investing in the industry.
Cannabis stocks largely gained Friday, with the Horizons Marijuana Life Sciences Index ETF HMMJ, +2.20%  rising 2.2%, and the ETFMG Alternative Harvest ETFMJ, +1.99%   increasing 2% for the day. The world’s largest pot company, Canopy Growth Corp. CGC, -0.20% WEED, -0.81%  fell 0.2%, Aurora Cannabis Inc.ACB, +4.37% ACB, +4.30%  was up 4.4%, and Tilray Inc. TLRY, +1.76%  closed up 1.8%.
– MedMen Enterprises Inc. MMNFF, -6.21%  Chief Financial Officer James Parker, who resigned from his post in November amid an equity raise which it cut in half, is suing the company in Los Angeles Superior Court for breach of contract and wrongful termination, among other things. At the time, MedMen refused to comment on the CFO departure and said cutting the financing nearly in half was due to a “significant selloff” in the global market. MedMen closed down 6.2% Friday.
The American pot retailer said early Friday that it expects to report fiscal second-quarter earnings Feb. 27 after the closing bell.
– Canadian weed producer The Green Organic Dutchman TGOD, +3.13%TGODF, +4.25%  — which has not yet sold any pot in the recreational market but is valued by investors at roughly $1 billion — also rose Friday, after it said would be able to increase its capacity to grow cannabis to 202,500 kilograms a year from 156,000 kilograms a year at its facilities in Canada. However, the company also said several phases of construction would be complete either at the long-end of the company’s previous projected schedule, or delayed until 2021. Dutchman stock closed up 4.3% in Friday trading.

– Weekend Unlimited Inc. WKULF, +163.96%  said Friday that it was the winner of Canada’s lottery for the POT ticker. Weekend Unlimited is a tiny cannabis company with a market capitalization of $46 million and no revenue to speak of in 2018, according to FactSet.
“There has been tremendous excitement generated globally for the POT symbol. The POT lottery served to raise the profile of Canada’s leadership in legal recreational cannabis and we believe it will also serve to raise Weekend Unlimited’s leadership profile,” Chief Executive Paul Chu said in a statement. Weekend Unlimited’s over-the-counter shares rose 164% to close at $0.2159.

Underage marijuana use, impaired driving common in Col., Wash. State

A new study by the University of Minnesota School of Public Health, published in the International Journal of Drug Policy, shows law enforcement agencies in Colorado and Washington—states where marijuana is legalized—report common problems with underage marijuana use (under age 21) and driving under the influence of marijuana in their communities.
“There’s a general public zeitgeist that  is a pretty safe drug,” said study co-author and Associate Professor Darin Erickson. “In actuality, there hasn’t been a lot of research regarding how marijuana is used, its safety or its harms.”
To learn how both states were enforcing age-restriction and driving laws regarding marijuana use, Erickson surveyed 50 local enforcement agencies in Colorado and Washington in 2016 and 2017 on: if they find underage  and impaired driving to be common problems in their cities; the types of enforcement they are using to counteract it; and the resources they have to aid them.
The study showed:
  • all local agencies reported underage use was somewhat or very common in their jurisdictions;
  • most agencies in both states reported marijuana-impaired driving was somewhat or very common in their jurisdictions;
  • 30 percent of local agencies conducted enforcement targeting underage use or possession;
  • 20 percent of agencies overall conducted underage compliance checks at licensed stores, with more agencies conducting checks in Colorado (32 percent) than Washington (8 percent);
  • one local agency in each state specifically targeted marijuana-impaired driving;
  • the state-level agency in Washington reported that its agency is the one primarily responsible for enforcing marijuana retail laws and it conducted routine underage compliance checks at all licensed marijuana stores three times per year.
“In general, we found that enforcement is not a high priority for most places,” says Erickson. “That said, we know enforcement strategies work to curb illegal substance use. Enforcing alcohol laws reduces underage drinking and related problems—and it could be used to improve the situation with marijuana.”
For solutions, Erickson recommends that states earmark tax money from retail marijuana sales to fund policy enforcement programs. He also suggests conducting additional research to develop roadside tests for impaired driving as well as  to learn how people typically use marijuana, such as in conjunction with alcohol.

Explore further

More information: Terra Wiens et al. Law enforcement practices in the first two states in U.S. to legalize recreational marijuana, International Journal of Drug Policy (2018). DOI: 10.1016/j.drugpo.2018.08.018

New clues to controlling HIV

The immune system is the body’s best defense in fighting diseases like HIV and cancer. Now, an international team of researchers is harnessing the immune system to reveal new clues that may help in efforts to produce an HIV vaccine.
SFU professor Mark Brockman and co-authors from the University of KwaZulu-Natal in South Africa have identified a connection between infection control and how well antiviral T cells respond to diverse HIV sequences.
Brockman explains that HIV adapts to the human immune system by altering its sequence to evade helpful antiviral T cells.
“So to develop an effective HIV vaccine, we need to generate host immune responses that the virus cannot easily evade,” he says.
Brockman’s team has developed new laboratory-based methods for identifying antiviral T cells and assessing their ability to recognize diverse HIV sequences.
“T cells are  that can recognize foreign particles called peptide antigens,” says Brockman. “There are two major types of T cells—those that ‘help’ other cells of the , and those that kill infected cells and tumours.”
Identifying the T cells that attack HIV antigens sounds simple, but Brockman says three biological factors are critical to a T cell-mediated . And in HIV infection, all three are highly genetically diverse.
He explains that for a T cell to recognize a peptide antigen, the antigen must first be presented on the cell surface by human leukocyte antigen proteins (HLA), which are are inherited.
And since many thousands of possible HLA variants exist in the human population, every person responds differently to infection. In addition, since HIV is highly diverse and evolves constantly during untreated infection, the peptide antigen sequence also changes.
Matching T cells against the HLA variants and HIV peptide antigens expressed in an individual is a critical step in the routine research process. But, says Brockman, “our understanding of T cell responses will be incomplete until we know more about the antiviral activity of individual T cells that contribute to this response.”
It is estimated that a person’s T cell “repertoire” is made up of a possible 20-100 million unique lineages of cells that can be distinguished by their T cell receptors (TCR), of which only a few will be important in responding to a specific antigen.
So to reduce the study’s complexity, the team examined two highly related HLA variants (B81 and B42) that recognize the same HIV peptide antigen (TL9) but are associated with different clinical outcomes following infection.
By looking at how well individual T cells recognized TL9 and diverse TL9 sequence variants that occur in circulating HIV strains, the researchers found that T cells from people who expressed HLA B81 recognized more TL9 variants compared to T cells from people who expressed HLA B42.
Notably, a group of T cells in some B42-expressing individuals displayed a greater ability to recognize TL9 sequence variants. The presence of these T cells was associated with better control of HIV infection.
This study demonstrates that individual T cells differ widely in their ability to recognize peptide variants and suggests that these differences may be clinically significant in the context of a diverse or rapidly evolving pathogen such as HIV.
Much work needs to be done to create an effective vaccine. However, says Brockman, “Comprehensive methods to assess the ability of T  to recognize diverse HIV sequences, such as those reported in this study, provide critical information to help design and test new vaccine strategies.”

Explore further

More information: Funsho Ogunshola et al, Dual HLA B*42 and B*81-reactive T cell receptors recognize more diverse HIV-1 Gag escape variants, Nature Communications (2018). DOI: 10.1038/s41467-018-07209-7

Novo accelerates launch plans for oral semaglutide

Novo Nordisk has said it is accelerating launch preparations for its new diabetes pill semaglutide, after investing in a voucher that will allow a fast review of the drug in the US.
The FDA grants priority reviews for drugs that it considers to be a significant improvement over available therapies for serious diseases.
After buying a special voucher from another company, Novo Nordisk is asking the FDA to to grant a fast-track review following a filing expected at the end of this quarter.
Although semaglutide is already available as a weekly injection known as Ozempic, diabetes patients may well prefer to take the GLP-1 class drug as a pill instead of an injection.
Novo Nordisk’s chief executive Lars Fruergaard Jørgensen revealed details in a briefing with journalists to accompany the firm’s Q4 results this morning.
The likely six month review period, as opposed to the standard ten month review, means the company is now in talks with payers to move forward the launch date.
He said: “Now we expect to shorten the review time with the FDA which means that the time we can start making contracts in the U.S. has also advanced.”
However Jørgensen did not reveal details about the pricing of oral semaglutide.
There is strong competition in the market for GLP-1 class drugs, as Eli Lilly has made significant inroads with its Trulicity (dulaglutide) weekly injection.
This has put pressure on Novo’s daily GLP-1 Victoza (liraglutide), although Ozempic is gaining traction after launching in the US last year. AstraZeneca also has a weekly GLP-1 injection Bydureon (exenatide).
In 2018, Ozempic’s sales were $276 million, and overall sales of GLP-1 drugs increased 18% in local currencies.
Shares in Novo rose almost 4% after the company revised its outlook and off the back of the sales from Ozempic, which were above forecasts.
The company expects 2019 sales growth of 2-5% and operating growth of 2-6%, in local currency.