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Pharma Executives Worried Over Presidential Candidates Demand for Drug Price Reform

Politics

Responding to tough talk by presidential candidates about price gouging by drug companies, pharmaceutical executives have told investors that they are working actively to influence the political debate. And in a move that reveals how much leeway drug firms actually have over pricing decisions, some are even saying that they have minimized price hikes in recent months to avoid attracting attention.


Democratic contenders Bernie Sanders and Hillary Clinton have both called for the government to do much more to bring down the price of medications. And last week, Republican candidate Donald Trump came out in support of allowing Medicare to negotiate for cheaper drug prices, a move that places him even to the left of some leaders in the Democratic Party.

On Thursday, former pharmaceutical executive Martin Shkreli refused to testify before a congressional panel about why they hiked prices on lifesaving drugs by as much as 5,000 percent.

The political environment has Wall Street worried. “We heard Bernie and Hillary last night go after drug pricing again and I think that's also something we are going to hear from the Republicans," warned Jami Rubin, the Goldman Sachs health care group analyst, on an earnings conference call last week for Johnson & Johnson.

Eli Lilly executive Jan Lundberg assured investors on his company's most recent earnings call that to combat the rhetoric around drug prices, the industry maintains “an active dialogue with each of the candidates" and will “work across party lines" to influence policy.

Merck chief executive Ken Frazier, speaking at the J.P. Morgan Health Care Conference in San Francisco last month, pledged to do more as chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's lobbying group. “With respect to the political dynamic," Frazier said, “I think the most important thing, and I try to do this in my role as head of PhRMA, is I think the industry needs to communicate better with the outside world."

At the same conference, Biogen chief executive George Scangos, who also serves as co-chairman of PhRMA, said his firm increased prices on three drugs recently, but at a “somewhat lower number" to avoid placing “a target on our foreheads." He added that “it's still possible to take price increases" but that he thinks “it's wise to be a little prudent."

James Hammergren, the chief executive of McKesson, which is the largest wholesale drug distributor in the nation, echoed the call for the industry to hold off on price hikes to avoid attracting unwanted scrutiny. “I would say that political discourse that's taking place, and the congressional inquiries relative to pricing practices, I think are obviously going to have people at least pausing perhaps to consider whether now is the right time to take a price increase," Hammergren said during a recent earnings call. In 2012, the firm paid $151 million to settle claims the firm deliberately overcharged Medicaid for reimbursements for some 1,400 brand-name drugs.

Vijay Das, who is a health care policy advocate at the consumer group Public Citizen, says that the recent statements confirm that the pharmaceutical industry's “pricing decisions are based upon the reach of their market and political power, not development costs or lengthy FDA approval process." He notes that PhRMA spent $18 million lobbying the federal government in 2015 alone. Records maintained by the Center for Responsive Politics show that drugmakers across the board spent more than $235 million on lobbying last year.

Das pointed to documents that show companies such as Johnson & Johnson spend more than twice the amount on marketing, sales and administrative costs than on research and development.

John Maraganore, the chief executive of Alnylam Pharmaceuticals, told investors on the company's recent earnings call that recent talk of drug pricing is “political demagoguery that's going on right now." He conceded, however, later in the call that companies will need to “think about their growth based on productivity not based on arbitrary price increases."

Shkreli made worldwide headlines for dramatically hiking prices of the drugs he bought. Newly reported emails show that Shkreli boasted that by boosting the price of Daraprim, his company would bring in $375 million a year, “almost all of it profit."

But other firms have steadily increased prices as well. Vanda Pharmaceuticals, for instance, has increased the prices of its drug Hetlioz, which treats sleep disorders for the blind, by 76 percent since it was introduced in 2014. (You may have seen its new TV ads, featuring an Afghan war veteran.)

Pfizer, since the beginning of last month, has raised prices an average of 10.6 percent for more than 60 branded products. Bloomberg reports that prices have doubled over the last year for over 60 brand-name drugs.

Meanwhile, PhRMA has reportedly invested in a new marketing campaign to boost the image of the industry.

Reprinted with permission from The Intercept.

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By Sherry H-Y. Chou, Aarti Sarwal and Neha S. Dangayach

The patient in the case report (let's call him Tom) was 54 and in good health. For two days in May, he felt unwell and was too weak to get out of bed. When his family finally brought him to the hospital, doctors found that he had a fever and signs of a severe infection, or sepsis. He tested positive for SARS-CoV-2, the virus that causes COVID-19 infection. In addition to symptoms of COVID-19, he was also too weak to move his legs.

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We are neurologists specializing in intensive care and leading studies related to neurological complications from COVID-19. Given the occurrence of Guillain-Barre Syndrome in prior pandemics with other corona viruses like SARS and MERS, we are investigating a possible link between Guillain-Barre Syndrome and COVID-19 and tracking published reports to see if there is any link between Guillain-Barre Syndrome and COVID-19.

Some patients may not seek timely medical care for neurological symptoms like prolonged headache, vision loss and new muscle weakness due to fear of getting exposed to virus in the emergency setting. People need to know that medical facilities have taken full precautions to protect patients. Seeking timely medical evaluation for neurological symptoms can help treat many of these diseases.

What Is Guillain-Barre Syndrome?

Guillain-Barre syndrome occurs when the body's own immune system attacks and injures the nerves outside of the spinal cord or brain – the peripheral nervous system. Most commonly, the injury involves the protective sheath, or myelin, that wraps nerves and is essential to nerve function.

Without the myelin sheath, signals that go through a nerve are slowed or lost, which causes the nerve to malfunction.

To diagnose Guillain-Barre Syndrome, neurologists perform a detailed neurological exam. Due to the nerve injury, patients often may have loss of reflexes on examination. Doctors often need to perform a lumbar puncture, otherwise known as spinal tap, to sample spinal fluid and look for signs of inflammation and abnormal antibodies.

Studies have shown that giving patients an infusion of antibodies derived from donated blood or plasma exchange – a process that cleans patients' blood of harmful antibodies - can speed up recovery. A very small subset of patients may need these therapies long-term.

The majority of Guillain-Barre Syndrome patients improve within a few weeks and eventually can make a full recovery. However, some patients with Guillain-Barre Syndrome have lingering symptoms including weakness and abnormal sensations in arms and/or legs; rarely patients may be bedridden or disabled long-term.

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Though Guillain-Barre Syndrome is rare, it is well known to emerge following bacterial infections, such as Campylobacter jejuni, a common cause of food poisoning, and a multitude of viral infections including the flu virus, Zika virus and other coronaviruses.

Studies showed an increase in Guillain-Barre Syndrome cases following the 2009 H1N1 flu pandemic, suggesting a possible connection. The presumed cause for this link is that the body's own immune response to fight the infection turns on itself and attacks the peripheral nerves. This is called an "autoimmune" condition. When a pandemic affects as many people as our current COVID-19 crisis, even a rare complication can become a significant public health problem. That is especially true for one that causes neurological dysfunction where the recovery takes a long time and may be incomplete.

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Due to the pandemic and infection-containment considerations, diagnostic tests, such as a nerve conduction study that used to be routine for patients with suspected Guillain-Barre Syndrome, are more difficult to do. In both U.S. cases, the initial diagnosis and treatment were all based on clinical examination by a neurological experts rather than any tests. Both patients survived but with significant residual weakness at the time these case reports came out, but that is not uncommon for Guillain-Barre Syndrome patients. The road to recovery may sometimes be long, but many patients can make a full recovery with time.

Though the reported cases of Guillain-Barre Syndrome so far all have severe symptoms, this is not uncommon in a pandemic situation where the less sick patients may stay home and not present for medical care for fear of being exposed to the virus. This, plus the limited COVID-19 testing capability across the U.S., may skew our current detection of Guillain-Barre Syndrome cases toward the sicker patients who have to go to a hospital. In general, the majority of Guillain-Barre Syndrome patients do recover, given enough time. We do not yet know whether this is true for COVID-19-related cases at this stage of the pandemic. We and colleagues around the world are working around the clock to find answers to these critical questions.

Sherry H-Y. Chou is an Associate Professor of Critical Care Medicine, Neurology, and Neurosurgery, University of Pittsburgh.

Aarti Sarwal is an Associate Professor, Neurology, Wake Forest University.

Neha S. Dangayach is an Assistant Professor of Neurology and Neurosurgery, Icahn School of Medicine at Mount Sinai.

Disclosure statement: Sherry H-Y. Chou receives funding from The University of Pittsburgh Clinical Translational Science Institute (CTSI), the National Institute of Health, and the University of Pittsburgh School of Medicine Dean's Faculty Advancement Award. Sherry H-Y. Chou is a member of Board of Directors for the Neurocritical Care Society. Neha S. Dangayach receives funding from the Bee Foundation, the Friedman Brain Institute, the Neurocritical Care Society, InCHIP-UConn Center for mHealth and Social Media Seed Grant. She is faculty for emcrit.org and for AiSinai. Aarti Sarwal does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Reposted with permission from The Conversation.


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In a series of tweets Wednesday night, Ocasio-Cortez—the lead sponsor of the House Green New Deal resolution—noted that the Climate Task Force "shaved 15 years off Biden's previous target for 100% clean energy."

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The 110 pages of policy recommendations from the six eight-person Unity Task Forces on education, the economy, criminal justice, immigration, climate change, and healthcare are aimed at shaping negotiations over the 2020 Democratic platform at the party's convention next month.

Sanders said that while the "end result isn't what I or my supporters would've written alone, the task forces have created a good policy blueprint that will move this country in a much-needed progressive direction and substantially improve the lives of working families throughout our country."

"I look forward to working with Vice President Biden to help him win this campaign," the Vermont senator added, "and to move this country forward toward economic, racial, social, and environmental justice."

Biden, for his part, applauded the task forces "for helping build a bold, transformative platform for our party and for our country."

"I am deeply grateful to Bernie Sanders for working with us to unite our party and deliver real, lasting change for generations to come," said the former vice president.

On the life-or-death matter of reforming America's dysfunctional private health insurance system—a subject on which Sanders and Biden clashed repeatedly throughout the Democratic primary process—the Unity Task Force affirmed healthcare as "a right" but did not embrace Medicare for All, the signature policy plank of the Vermont senator's presidential bid.

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Marisa Franco, director of immigrant rights group Mijente, said in a statement that "going into these task force negotiations, we knew we were going to have to push Biden past his comfort zone, both to reconcile with past offenses and to carve a new path forward."

"That is exactly what we did, unapologetically," said Franco, a member of the Immigration Task Force. "For years, Mijente, along with the broader immigrant rights movement, has fought to reshape the narrative around immigration towards racial justice and to focus these very demands. We expect Biden and the Democratic Party to implement them in their entirety."

"There is no going back," Franco added. "Not an inch, not a step. We must only move forward from here."

Reposted with permission from Common Dreams.