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Cure To Blindness: $850K Price

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(via Zerohedge)

How much is a patient’s eyesight worth?

That’s a corollary question that a transformative medical treatment released by Spark Therapeutics seeks to answer. The treatment, known as Luxturna, has the potential to cure a rare genetically inherited form of blindness, according to Bloomberg.


Luxturna

The price tag? $850,000 – or $425,000 per eye.

A transformative genetic treatment for a rare, inherited form of blindness will come with a price tag of of $425,000 per eye, or $850,000 for both, said Spark Therapeutics Inc., the tiny biotechnology company that is bringing the therapy to market.

Since Spark’s Luxturna was approved by the U.S. Food and Drug Administration last month, speculation over the price has grown as it became clear the therapy would be one of the first in a wave of medicines that yield remarkable results after a single treatment – and would carry a commensurate cost.

Of course, few patients will pay the whole amount out-of-pocket. Even for the uninsured, Spark will offer discounts based on whether or not the drug works initially and remains effective for the estimated 1,000 to 2,000 patients in the US with the inherited retinal disease caused by the gene mutation that the medication treats.

Though the price tag also reflects what Spark CEO Jeff Marrazzo describes as the drug’s “life-altering” properties.


“We believe that this price reflects not only the breakthrough, life-altering value of one-time Luxturna, but it will enable us to continue to invest and build on the revolutionary science that supports not only Luxturna but the rest of our pipeline,” Chief Executive Officer Jeff Marrazzo said in a phone interview.

The company’s “novel” pricing scheme was devised to help placate insurers who don’t want to get stuck paying for the entire course of treatment if a patient changes plans while still enjoying the benefits of the treatment, which only needs to be administered one time.

A one-time treatment presented a challenge, since the cost would be paid for by one insurer or government, only to have others reap the benefits when the patient changes coverage.

To help mitigate that dynamic, Spark is rolling out several programs to spread out the cost over the years or give rebates to payers if the benefits wane with time.

For example, the company said it’s discussing a program with the U.S. Centers for Medicare & Medicaid Services that would spread payments for Luxturna over several years, even though the therapy would be given only once. It didn’t say how many installments would be made, or how long it would take to pay the full cost of the drug.

Insurers are also wary of getting stuck with the entire bill if the treatment proves ineffective, or if its benefits only persist for a brief period.

In an agreement with the Boston-area insurer Harvard Pilgrim Health Care, Spark will get the full price of treatment up front. If patients don’t get an immediate benefit – measured at 30 days, or a long term one – measured at 30 months, Spark will have to give some of the money back in a rebate.

Spark has also proposed selling the gene therapy directly to insurance companies or specialty pharmacies. That would sidestep the current process that requires hospitals or health care providers to buy expensive therapies upfront. Spark is working with Express Scripts Holding Co. on such an arrangement, and said it’s talking with other drug plans.

However, some insurers said they expected the drug to cost even more, considering the narrow customer base.

Express Scripts has been a frequent critic of costly drugs, yet said that the Spark treatment is an exception.

“Many people were anticipating this would be more than a million dollars” said Steve Miller, the St. Louis-based company’s chief medical officer. “In the end, this is a revolutionary product, and I think in most plans this will be covered.”

Spark’s biggest challenge may be finding patients to treat.

Of the few thousand people with the disease, only a few have actually been tested and confirmed to have it, since there was no cure, and thus little use in diagnosis. Many with more advanced forms of the disease won’t qualify for treatment, according to the company.

President Donald Trump has shaken pharmaceutical stocks, like he did back in October, when he criticized pharmaceutical companies for charging too much for their drugs, and nebulously threatened to do something about drug prices (though as of yet no direct action has been forthcoming).

However, Spark may need to raise the price if its medication if it doesn’t find enough people to treat. Only a few thousand people in the US possess the genetic mutation that the drug treats. And many of them won’t qualify for treatment.

Spark’s biggest challenge may be finding patients to treat.

Of the few thousand people with the disease, only a few have actually been tested and confirmed to have it, since there was no cure, and thus little use in diagnosis. Many with more advanced forms of the disease won’t qualify for treatment, according to the company.

So, what’s a specialty drug maker to do?

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Health

mRNA COVID-19 Injections Not Vaccines – Ninth Circuit Rules

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In a recent decision that has stirred up discussions across the nation, the Ninth Circuit Court of Appeals ruled that the COVID-19 mRNA injections do not qualify as vaccines under traditional medical definitions. This decision was made in a lawsuit brought by the Health Freedom Defense Fund and other plaintiffs against the Los Angeles Unified School District (LAUSD). The court’s decision could potentially expose pharmaceutical companies to future liability lawsuits, as it challenges the legal protections typically afforded to vaccine manufacturers.

The lawsuit against LAUSD was based on the claim that the district’s vaccine mandate infringed upon the plaintiffs’ fundamental right to refuse medical treatment. The court, in a majority opinion authored by Circuit Judge R. Nelson and supported by Judge Collins, asserted that the mRNA shots, marketed as vaccines, do not effectively prevent the transmission of COVID-19 but merely reduce symptoms in those who contract the virus. This distinction, the court argued, means that the injections should not be considered vaccines under traditional medical definitions.

The implications of this ruling are significant. If mRNA injections are not considered vaccines, then they may not be subject to the same legal protections as traditional vaccines. This could potentially open the door to liability lawsuits against pharmaceutical companies that have produced and distributed the injections.

The court’s decision has sparked a range of reactions on social media. Some users have expressed relief and support for the ruling, viewing it as a step towards greater transparency and accountability in the handling of the pandemic. Others have criticized the decision, arguing that it undermines public health efforts and could discourage the use of potentially life-saving treatments.

The ruling has also reignited debates about the handling of the pandemic and the promotion of alternative treatments. Some have questioned the effectiveness of the mRNA injections, while others have pointed to the rapid development and deployment of these treatments as a remarkable achievement in the face of a global crisis.

As the legal implications of this ruling continue to unfold, it is likely that the debate surrounding the COVID-19 pandemic and the role of vaccines in public health will continue to evolve. The Ninth Circuit’s decision serves as a reminder of the complex legal and ethical issues at the heart of public health policy.

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Health

Tea Time: Government Health Care Strikes Again

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Less than a year ago the vaunted “free” British government National Health Care Service (NHS) that is so admired by liberals here, killed 11 month old Charlie Gard when it refused to continue treating Charlie’s serious and likely terminal illness but worse, refused to allow his parents to take him to the United States at their expense where a couple of doctors believed they could give him a fighting chance. Charlie’s parent lost in their appeals to the British courts and even the UE Court of Human Rights and little Charlie lost his life.

This sad tale was recently repeated when 23 month old Alfie Evans who suffered from a neurodegenerative disorder and required assistance with ventilation and hydration died late last month after the NHS stopped treating him. The NHS determined that further treatment for the boy was “futile” which may be another way to say that they do not see a future return on their investment. The Pope had intervened and an Italian hospital offered to continue the boy’s treatment and the Italian government even offered him citizenship – all gallant efforts to give this young child a chance at life. Unfortunately none of these offers for help were ever utilized because once again the NHS refused to
release the boy to his parents and the British court system and the EU Court of Human Rights once again ruled in favor of government bureaucracy instead of in favor of life.

This episode is another warning for Republicans to repeal the smoldering remains of Obamacare and its internal potential death panel, the Independent Payment Advisory Board (IPAB). If you think my “death panel language is a bit over the top, let me remind you that it nearly happened here in 2013 when then Secretary of Health and Human Services Kathleen Sebelius denied a much needed lung transplant for 10 year old Sarah Murnagham, because she was too young for the 12 year age limit the government had established. Fortunately, the public firestorm ultimately forced Sebelius to allow the surgery, but she did it because of the optics, not because it was right.

While it is true the Republicans dealt Obamacare a death blow with the elimination of the individual mandate they have not taken all of the possible actions to enable the private insurance market fill the varying needs of Americans which would make it easier for the federal government to largely get out of health care where it never belonged in the first place. The president remains ready to sign any reasonable repeal bill the Republican controlled congress will bring him, but after 16 months he is still waiting.

-Larry Wiwi for the Franklin County Tea Party

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Culture

California STD Cases Rise 45% In 5 Years

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Zerohedge Reports: Sexually transmitted disease (STD) cases have reached record-high numbers in California, the Los Angeles Times reports, as the ‘sharing’ economy goes viral.

In 2017, the number of California residents diagnosed with gonorrhea (over 13,000 cases), chlamydia (over 75,000 cases) or syphilis (over 218,000 cases) hit a consecutive three-year record, according to the California Department of Public Health.

The 300,000+ people diagnosed last year represents a 45-percent increase in STD cases since 2013.

Those most commonly affected by chlamydia and gonorrhea are under 30 years old. As The Sacramento Bee reports, “Rates of chlamydia are highest among young women, while men account for the majority of syphilis and gonorrhea cases.”

“While there are advocates and champions for cancer, nobody is out there saying, ‘I have gonorrhea and these are the best ways to treat it.’ There’s no one out there being a champion for these conditions,” said Klausner.

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