Drug extends life of younger women with advanced breast cancer

Younger women suffering from a common form of advanced breast cancer have experienced significantly improved survival rates when treated with a drug that targets cancer cells, according to the findings of an international clinical trial.


CNN.com – RSS Channel – Health

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‘The IAAF Will Not Drug Me.’ Olympian Caster Semenya Appeals Court’s Testosterone Ruling

(JOHANNESBURG) — Caster Semenya has appealed against the Court of Arbitration for Sport’s decision to uphold testosterone regulations for some female athletes in track and field.

The two-time Olympic 800-meter champion’s lawyers say she has lodged an appeal with the Swiss Federal Tribunal, Switzerland’s supreme court.

Under the IAAF’s new rules, upheld by the Switzerland-based CAS this month, Semenya is not allowed to run in international races from 400 meters to one mile unless she medically lowers her natural testosterone levels. She said after the CAS decision that she would not take medication and repeats in Wednesday’s statement announcing her appeal that “the IAAF will not drug me or stop me from being who I am.”

Semenya’s appeal was announced by her South Africa-based lawyers. They say Semenya’s appeal “focuses on fundamental human rights.”

Sports – TIME

ENTERTAINMENT DEAL UPDATE:

Big drug distributor pays $22 million to settle US opioid charges

Morris & Dickson, one of the largest U.S. wholesale drug distributors, agreed to pay $ 22 million in civil penalties to settle U.S. government charges that it failed to report thousands of suspicious orders of the opioids hydrocodone and oxycodone.
Health and Science

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Brainstorm Health: Free HIV Medication, J&J Ketamine Drug Price, Physician Suicide

Happy Friday, readers!

As we head into the weekend, a bit of intriguing news from the biotech world–drug giant Gilead will be donating hundreds of thousands of doses of HIV prevention drugs as part of a deal reached with the Trump administration.

“I’m pleased to announce that as a result of discussions between the Trump Administration and Gilead Sciences, Inc., Gilead has agreed to make a historic donation of HIV prevention medication for up to 200,000 individuals each year for up to 11 years,” wrote Health and Human Services Secretary Alex Azar in a tweet.

The treatment in question is a so-called PrEP drug called Truvada and, if actually enacted, could equate to several million bottles being given out to uninsured patients at high risk of contracting HIV. Truvada has shown to cut the risk of HIV transmission by well over 90% (if used regularly) among such patients.

Gilead’s deal with the administration is interesting for several reasons. For one, it’s part of President Donald Trump’s stated campaign to eliminate HIV in America. But it also hits on the reality that, despite Truvada’s existence, thousands upon thousands of patients who could benefit from it don’t have the financial resources to do so (it can cost close to $ 2,000 per month out of pocket).

It’s not a pure charity play by Gilead, though–the deal would only be in effect until the successor to Truvada hits the market. And that drug may eventually prove even more expensive than what’s already available.

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

DNA testing startups’ bumpy road. Bloomberg has a fascinating report on the shifting strategies among DNA testing upstarts as they grapple with the complications of a highly personal, sensitive, and regulated industry. The a la carte DNA testing platform Helix serves as a prominent example: Once envisioned as a company that would conduct genetic testing and then allow users to access various other companies’ services (whether for health or ancestry reasons), Helix is now looking to partner with health care providers who have more direct access to patients. (Bloomberg)

INDICATIONS

Johnson & Johnson criticized over ketamine depression drug price. Johnson & Johnson recently made history with an approved depression treatment derived from ketamine (commonly used as a party drug). But watchdogs are criticizing the company for what they say is unfair pricing. While the Institute for Clinical and Economic Review (ICER) considered the drug, Spravato, generally effective, cost-effectiveness was another question (the list price ranges from $ 4,720 to $ 6,785 for the first month of treatment and $ 2,360 to $ 3,540 in following months). “Esketamine shows some benefits for such patients and provides an FDA-approved treatment for treatment resistant depression [TRD] that may be covered by payers; however, it is concerning to have an overpriced therapy where there is such need for treatment. Additionally, the similarity of ketamine to esketamine raises issues for all stakeholders about how to consider off-label prescription and coverage of a treatment that has not been as well studied but is being increasingly used for TRD,” said ICER chief medical officer David Rind in a statement.

THE BIG PICTURE

Why are doctors dying by suicide? A pair of physicians (from Canada) have co-authored a paper exploring one of the most vexing questions in medicine: Why do physicians die by suicide at such high rates? One of the more interesting observations laid out by the study authors is that doctors may consider themselves physicians but not patients, potentially eschewing the very kind of help they’d prescribe to others. (Reuters)

REQUIRED READING

Commentary: Want to Lower Drug Costs for Patients? Start With Rebates, by Olivier Brandicourt & Steve Ubl

Uber’s IPO Hits a Red Light as Stock Price Stays Below Opening, by Erik Sherman

Jeff Bezos Wants to Deliver You to the Moon, by Bloomberg

[ceo_attribution author=”Produced by Sy Mukherjee” email=”sayak.mukherjee@fortune.com” twitter=”the_sy_guy”] Find past coverage. Sign up for other Fortune newsletters.

Fortune

SPECIAL NEWS BULLETIN:

http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

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FDA undercuts $375,000 drug in surprise move

The US Food and Drug Administration created a workaround this week that effectively undercuts the $ 375,000 price tag of a drug that became the poster child for concerns about the pharmaceutical industry.


CNN.com – RSS Channel – Health

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Pharma ads will soon be required to include drug prices

Pharmaceutical companies will soon be required to include their products’ prices in TV ads, under a new rule that the Trump administration hopes will drive down prescription-drug costs, officials said Wednesday. The Department of Health and Human Services regulation, slated to take effect in July, will require commercials to display a drug’s Wholesale Acquisition Cost…
Business | New York Post

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Drug Industry Patents Go Under Senate Judiciary Committee’s Microscope

Congress isn’t making much headway in finding a solution to the problem of soaring prescription drug prices, but lawmakers from both parties are tinkering on the edges with legislation that aims to increase competition among drugmakers.

A comprehensive piece of drug-pricing legislation is a high priority for Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Ron Wyden (D-Ore.). And it could be introduced by mid-June, according to congressional staff.

But while that is hashed out, a slate of options to reform drug patents is working its way through the Senate Judiciary Committee, which had a hearing Tuesday featuring academics, patient advocates and a representative from the pharmaceutical industry. Their mission: to increase competition without decreasing innovation in the industry.

“I think we’re dangerously close to building a bipartisanship consensus around change,” Sen. Dick Durbin (D-Ill.) said during the hearing.

The four proposed bills share a common goal: avoiding some of the thorny issues around drug pricing, like whether the government will set drug prices or negotiate with manufacturers on what federal programs will pay. Instead, the patent reform proposals get at the ways branded drug manufacturers use patents, and the legal monopolies that are granted with patents, to keep lower-priced generic competitors from reaching patients.

“A package of patent reforms are important because they fix systemic problems that allow prices to go up and keep them high,” testified David Mitchell, the president of Patients for Affordable Drugs, a Washington, D.C.-based advocacy group focused on lowering prescription drug prices.

Sen. John Cornyn (R-Texas) offered specific examples of drugs that have benefited from system issues, including Humira, an expensive drug for arthritis and psoriasis that is protected by 136 patents.

That’s called a “patent thicket,” because it prevents a generic alternative from entering the market for more years — in this case, until 2023 for a drug first approved for use in the United States in 2002. “Is there anyone on the panel who’d like to defend the status quo?” he asked.

“There is no way a biosimilar can deal with a hundred patents,” testified Michael Carrier, a professor at Rutgers Law School. “This is an abuse of the system.”

Among the proposed bills, the Stop STALLING (“Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics”) Act — the bipartisan brainchild of Sen. Amy Klobuchar (D-Minn.) and Grassley — is supposed to put a stop to “sham” citizen petitions to the FDA. Critics say these petitions are often introduced by drugmakers under the guise of patient advocacy to slow FDA approval of new generic medicines. “Nearly every one of these citizen petitions is brought by a brand company. None are filed by individuals. I love the legislation. I would go even stronger,” Carrier said.

Grassley is also the lead sponsor on the bipartisan Prescription Pricing for the People Act of 2019. It directs the Federal Trade Commission to investigate mergers of pharmacy benefit managers, the middlemen that negotiate between drugmakers and health plans.

Klobuchar and Grassley teamed up again on another measure, the Preserve Access to Affordable Generics and Biosimilars Act, which they  say would end “anti-competitive behavior” — specifically, deals struck between branded companies and generic companies to keep a generic, or a biosimilar, off the market. Klobuchar, a Democratic presidential candidate, has frequently discussed her opposition to this practice on the campaign trail.

James Stansel — the executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, and the lone voice of the pharmaceutical industry on the panel — cautioned against moving too aggressively on this point. “We want to make sure we don’t do something that’s anti-competitive in the hopes it would be pro-competitive,” he said.

There’s also the CREATES (“Creating and Restoring Equal Access to Equivalent Samples”) Act, introduced by Sen. Patrick Leahy (D-Vt.) with 31 bipartisan co-sponsors and endorsed by nearly every witness on Tuesday’s panel. It’s supposed to crack down on branded companies that refuse to sell samples of their drugs to generic companies, a necessary step to increasing the number of generics on the market.

Versions of all four of those bills have also been introduced in the House and advanced out of the House Judiciary Committee.

“The American people are being played for chumps,” said Sen. John Kennedy (R-La.). “Just chumps. And it’s got to stop.”

Kaiser Health News

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External reference drug pricing could save medicare tens of billions

A new study found that prices for brand-name prescription drugs averaged 3.2 to 4.1 times higher in the US when compared with prices in the United Kingdom, Japan and the Canadian province of Ontario. The study also found that the longer the brand-name prescription drug was on the market, the greater the price differential.
Consumer Behavior News — ScienceDaily

PARENTAL UPDATE:

Bobby Brown Slams Chris Rock’s ‘Tasteless’ Joke About Whitney’s Drug Use

Bobby Brown was not amused when Chris Rock made time over the weekend to post a tasteless joke about Whitney Houston’s drug use.

Rock shared a meme on social media of the late singer looking anything but enthusiastic about giving an interview. The image read: “Me sitting in a meeting that could’ve been an email,” but the comedian added his own caption: “Hurry up I got crack to smoke.”

Many commenters slammed the joke as “tasteless” and  “trash” and simply “not funny,” but  Brown noted, “During this time of women empowerment you chose to use your time to try and humiliate our QUEEN!!!”

He added, “I thought you was a friend of the family.”

Peep the post below.

Rock ultimately deleted the post.

Bobby and Whitney were married from 1992 to 2007 and had one child together, Bobbi Kristina, who died in 2015, three years after Houston drowned in a bathtub while reportedly acutely intoxicated from cocaine. Bobbi Kristina died in a similar manner to her mother.

Houston, who was 48 when she died, denied using crack cocaine during a 2002 interview with Diane Sawyer.

“I make too much money to ever smoke,” she said. “Let’s get that straight, k? We don’t do crack. We don’t do that. Crack is wack.”

Brown previously blasted Kanye West for paying $ 85,000 to license a photo of Houston’s drug den inside her  Atlanta home for the cover of Pusha-T’s album “Daytona.”

[ione_media_gallery id=”557868″ overlay=”true”]

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Mulvaney: Trump Brought Down Drug Prices For The First Time In 50 Years

President Donald Trump announced last month that the GOP will become “the party of health care,” and news reports suggest he intends to make it a top issue in his reelection campaign.

So when Mick Mulvaney, the acting White House chief of staff, touted the administration’s work on prescription drug prices — a hot-button issue that has drawn scrutiny from across the political spectrum, and one that voters say should be a top priority — we were intrigued.

On “Fox News Sunday” April 7, Mulvaney said: “Drug prices in this country actually came down last year for the first time in 50 years. That’s because Donald Trump’s president.”

This statement is particularly hard to prove affirmatively. Drug prices are measured through a host of metrics and affected by all sorts of political and economic forces.

We reached out to the White House for more explanation. Its staff directed us to a report published last October by its Council of Economic Advisers, as well as to data suggesting the consumer price index for prescription drugs declined in January 2019 compared with January 2018.

But experts who reviewed that data said it doesn’t necessarily support Mulvaney’s claim — and certainly not by the magnitude he suggests.

A Broad Brush, And Some Missing Data

We interviewed five experts who all agreed that, no matter which metric was used, evidence is lacking to unequivocally say drug prices decreased last year. The most generous reading came from Matthew Fiedler, a health economist at the Brookings Institution: It’s “within spitting distance of something that’s true.”

But with more examination, the claim’s veracity became murkier.

“Drug prices” can refer to many things: a list price, a net price (what is paid after rebates, or the discounts negotiated by insurers or other payers), the pharmacy’s price or total national spending on prescription drugs.

Let’s start with the latter. Data from the Kaiser Family Foundation shows total spending on prescription drug prices has climbed during the past several years. (KHN is an editorially independent program of the foundation.) In 2018, total spending continued to grow, just at a slower pace. That’s a positive trend, experts noted, but it isn’t the same thing as spending going down.

“It doesn’t mean we’re spending less money on drugs than before,” said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University.

We also examined the CPI data the White House provided. It could suggest that in the past year prescription drugs’ list prices have indeed dropped, and even by a meaningful amount.

But the CPI data doesn’t account for whether manufacturers lowering their list prices have also changed the size of the rebates they provide. That’s essential information in understanding if the real price of a drug — what insurance pays and, ultimately, what consumers pay — has actually changed.

These trend lines also vary depending on the 12-month period they cover, argued Walid Gellad, an associate health policy professor at the University of Pittsburgh. January to January could show a list price decrease, but July to July could show an increase.

Plus, the CPI data includes only drugs sold through retail, or about three-fourths of all prescriptions. That excludes many high-priced specialty meds sold only via mail order, argued Michael Rea, who heads Rx Savings Solutions, a consulting firm.

It also paints with a broad brush — obscuring, many said, just how many list prices are continuing to climb.

This year, the list price of more than 3,000 drugs went up, while the price of only 117 went down, according to data compiled by Rx Savings Solutions. Last year, an analysis by the Associated Press revealed that, from January to July, 4,412 branded drug prices went up, while 46 were cut.

So, Mulvaney’s downward price claim didn’t come out of thin air. But interpreting the data to mean that drug prices are down ignores crucial parts of the prescription drug marketplace.

The White House’s Work

Mulvaney also said Trump has played a key role in bringing down drug prices. When we asked the administration what he meant, a spokesman pointed to their efforts to bring more generic drugs to market — a boost the White House said has fueled competition and helped make lower-price alternatives available to consumers.

But there’s no evidence yet to suggest that the boost in generic drug approvals has that effect. Experts said it takes time for these products to reach the marketplace, create competition and demonstrate a measurable impact on prices.

Indeed, many of those generics, while approved, never went to market. This White House assertion also doesn’t account for high-priced, branded drugs that lack a generic counterpart.

Yes, Trump’s tough talk — accusing pharma companies of “getting away with murder” — may have persuaded some drug manufacturers to hold off on increasing their prices — at least temporarily, or until after the government releases key stats on how many prices have gone up, Dusetzina said. But it’s hard to separate that phenomenon from the pressure also levied by Congress and state legislatures.

For what it’s worth, the administration has proposed many new policies meant to curb drug prices, many noted, such as eliminating some kinds of rebates, or changing how Medicare Part B pays for drugs. But none of those have taken effect — so they haven’t brought prices down.

Our Ruling

Mulvaney said, “Drug prices in this country actually came down last year for the first time in 50 years. That’s because Donald Trump’s president.”

At first glance, CPI data could conceivably support the argument that the list prices for some prescription drugs dipped. But that data doesn’t include many high-priced specialty drugs that drive costs up, and the pattern it illustrates can change based on the time frame selected.

The CPI data set obscures the individual drugs for which the list prices have increased — with far more going up than down. It also does not account for a drug’s true “net price.”

Mulvaney’s statement also does not reflect trends showing that, nationally, spending on drugs has continued to climb, even if that growth has slowed. There is also no evidence to support the argument that Trump himself is responsible for changes in drug pricing.

This claim has an element of truth, but it ignores key facts and context that would give a very different impression. We rate this claim Mostly False.

Kaiser Health News

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Brainstorm Health: Brain Stimulation, GSK HIV Drug, Telemedicine and Antibiotics

Happy Monday, readers–I hope you had a wonderful weekend.

Alzheimer’s and dementia researchers have had to endure a cascade of heartbreaking drug development failures in recent years. Traditional pharmaceutical treatments based on the “beta amyloid” theory have failed… and failed… and failed yet again.

So perhaps it’s not surprising that some scientists are hitching their wagons to radically different approaches. A team of Boston University researchers claim that a form of electrical brain stimulation has produced surprising (if very, very early) results in boosting cognitive skills.

It’s important to take these kinds of preliminary results with a grain (or ten) of salt. After all, more conventional Alzheimer’s drug hopefuls have shown early promise only to face humiliating defeats down the line.

But the research is undeniably interesting. Neuroscientists found that electrically (but harmlessly) zapping the regions of the brain related to what’s called “working memory”–i.e., short-term memories critical to conducting certain immediate tasks–can temporarily improve this sort of memory in older people. In fact, the electrical bridging of the prefrontal and temporal regions of the brain reportedly helped improve working memory function in older adults to similar levels as people who were significantly younger.

Still, this wasn’t a randomized clinical trial, and it certainly wasn’t a robust one. When it comes to dementia treatment, past experience suggests a cautious outlook.

Read on for the day’s news.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

Does telemedicine carry an antibiotic risk? A new study suggests a correlation between use of telemedicine and increased antibiotic prescriptions, according to the Associated Press. In fact, the University of Pittsburgh researchers found that telemedicine visits weren’t just associated with far more antibiotic use by children–they were linked to prescriptions that didn’t follow common guidelines for such therapies. (Associated Press)

INDICATIONS

FDA approves Glaxo’s two-drug HIV regimen. The Food and Drug Administraiton (FDA) on Monday approved British drug giant GlaxoSmithKline’s pioneering two-drug combo therapy to treat a form of HIV. “Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” explained the FDA’s Dr. Debra Birnkrant, who heads the antiviral products arm of the agency. Fewer treatments in a drug regimen generally corresponds with fewer side effects and can be cheaper. The GSK drug is called Dovato. (FDA)

Regeneron strikes $ 800 million Alnylam deal. Regeneron is putting its money where its mouth is on gene therapies, striking an $ 800 million deal (in straight up cash and equity) with the “gene silencing” biotech Alnylam. Alnylam is focused RNA interference treatments, a method of turning disrupting gene communication that’s used to make certain proteins (which may be associated with certain diseases).

THE BIG PICTURE

Measles cases continue to rise. There have now been 465 reported cases of measles in the U.S. this year, a 78-case increase from just last week that threatens to match 2014’s all-time record, the Centers for Disease Control (CDC) reports. (CNN)

REQUIRED READING

Why ‘Move Fast and Break Things’ Is Out, by Adam Lashinsky

Do Violent Videos Radicalize People? by Robert Hackett

How to Make Your Smartphone a Tool–And Not a Temptation, by Erika Fry

The Short Sellers Are Coming for Lyft, by Lucinda Shen

[ceo_attribution author=”Produced by Sy Mukherjee” email=”sayak.mukherjee@fortune.com” twitter=”the_sy_guy”] Find past coverage. Sign up for other Fortune newsletters.

Fortune

SPECIAL NEWS BULLETIN:

http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

CHARITY UPDATE:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

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Doughnut Hole Is Gone, But Medicare’s Uncapped Drug Costs Still Bite Into Budgets

Three times a week, Tod Gervich injects himself with Copaxone, a prescription drug that can reduce the frequency of relapses in people who have some forms of multiple sclerosis. After more than 20 years with the disease, Gervich, 66, is

Unlike commercial plans that cap members’ out-of-pocket drug spending annually, Medicare has no limit for prescription medications in Part D, its drug benefit. With the cost of specialty drugs increasing, some Medicare beneficiaries could owe thousands of dollars in out-of-pocket drug costs every year for a single drug.

Recent proposals by the Trump administration and Sen. Ron Wyden (D-Ore.) would address the long-standing problem by imposing a spending cap. But it’s unclear whether any of these proposals will gain a foothold.

The 2006 introduction of the Medicare prescription drug benefit was a boon for seniors, but the coverage had weak spots. One was the so-called doughnut hole — the gap beneficiaries fell into after they accumulated a few thousand dollars in drug expenses and were on the hook for the full cost of their medications. Another was the lack of an annual cap on drug spending.

Legislative changes have gradually closed the doughnut hole so that, this year, beneficiaries no longer face a coverage gap. In a standard Medicare drug plan, beneficiaries pay 25 percent of the price of their brand-name drugs until they reach $ 5,100 in out-of-pocket costs. Once patients reach that threshold, the catastrophic portion of their coverage kicks in and their obligation drops to 5 percent. But it never disappears.

It’s that ongoing 5 percent that hits hard for people, like Gervich, who take expensive medications.

His 40-milligram dose of Copaxone costs about $ 75,000 annually, according to the National Multiple Sclerosis Society. In January, Gervich paid $ 1,800 for the drug and another $ 900 in February. Discounts that drug manufacturers are required to provide to Part D enrollees also counted toward his out-of-pocket costs. (More on that later.) By March, he hit the $ 5,100 threshold that pushed him into catastrophic coverage. For the rest of the year, he’ll owe $ 295 a month for this drug, until the cycle starts over again in January.

That $ 295 is a far cry from the approximately $ 6,250 monthly Copaxone price without insurance. But, combined with the $ 2,700 he already paid before his catastrophic coverage kicked in, the additional $ 2,950 he’ll owe this year is no small amount. And that assumes he needs no other medications.

Tod Gervich injects himself with the prescription drug Copaxone, three times a week. While he’s accustomed to managing his condition, he can’t get used to Medicare’s high coinsurance payments.(Courtesy of Tod Gervich)

“I feel like I’m being punished financially for having a chronic disease,” he said. He has considered discontinuing Copaxone to save money.

His drug bill is one reason Gervich has decided not to retire yet, he said.

An annual cap on his out-of-pocket costs “would definitely help,” said Gervich, a self-employed certified financial planner in Mashpee, Mass.

Drugs like Copaxone that can modify the effects of the disease have been on a steep upward price trajectory in recent years, said Bari Talente, executive vice president for advocacy at the National Multiple Sclerosis Society. Drugs that used to cost $ 60,000 annually five years ago cost $ 90,000 now, she said. With those totals, Medicare beneficiaries “are going to hit catastrophic coverage no matter what.”

Specialty-tier drugs for multiple sclerosis, cancer and other conditions — defined by Medicare as those that cost more than $ 670 a month — account for more than 20 percent of total spending in Part D plans, up from about 6 percent before 2010, according to a report by the Medicare Payment Advisory Commission, a nonpartisan agency that advises Congress about the program.

Just over 1 million Medicare beneficiaries in Part D plans who did not receive low-income subsidies had drug costs that pushed them into catastrophic coverage in 2015, more than twice as many as the 2007 total, an analysis by the Kaiser Family Foundation found. (KHN is an editorially independent program of the foundation.)

“When the drug benefit was created, 5 percent probably didn’t seem like that big a deal,” said Juliette Cubanski, associate director of the Program on Medicare Policy at the Kaiser Family Foundation. “Now we have such expensive medications, and many of them are covered under Part D — where, before, many expensive drugs were cancer drugs” that were administered in doctors’ offices and covered by other parts of Medicare.

The lack of a spending limit for the Medicare drug benefit sets it apart from other coverage. Under the Affordable Care Act, the maximum amount someone generally owes out-of-pocket for covered drugs and other medical care for this year is $ 7,900. Plans typically pay 100 percent of customers’ costs after that.

The Medicare program doesn’t have an out-of-pocket spending limit for Part A or Part B, which cover hospital and outpatient services, respectively. But beneficiaries can buy supplemental Medigap plans, some of which pay coinsurance amounts and set out-of-pocket spending limits. Medigap plans, however, don’t cover Part D prescription plans.

Counterbalancing the administration’s proposal to impose a spending cap on prescription drugs is another that could increase many beneficiaries’ out-of-pocket drug costs.

(Credit: Department of Health and Human Services)

Currently, brand-name drugs that enrollees receive are discounted by 70 percent by manufacturers when Medicare beneficiaries have accumulated at least $ 3,820 in drug costs and until they reach $ 5,100 in out-of-pocket costs. Those discounts are applied toward beneficiaries’ total out-of-pocket costs, moving them more quickly toward catastrophic coverage. Under the administration’s proposal, manufacturer discounts would no longer be treated this way. The administration said this would help steer patients toward less expensive generic medications.

Still, beneficiaries would have to pay more out-of-pocket to reach the catastrophic spending threshold. Thus, fewer people would likely reach the catastrophic coverage level where they could benefit from a spending cap.

“Our concern is that some people will be paying more out-of-pocket to get to the $ 5,100 threshold and the drug cap,” said Keysha Brooks-Coley, vice president of federal affairs at the American Cancer Society Cancer Action Network.

“It’s kind of a mixed bag,” said Cubanski of the proposed calculation change. “There will be savings for some individuals” who reach the catastrophic phase of coverage. “But for many there will be higher costs.”

For some people, especially cancer patients taking chemotherapy pills, the lack of a drug-spending cap in Part D coverage seems especially unjust.

These cutting-edge targeted oral chemotherapy and other drugs tend to be expensive, and Medicare beneficiaries often hit the catastrophic threshold quickly, said Brooks-Coley.

Patty Armstrong-Bolle, who lives in Haslett, Mich., takes Ibrance, a pill, once a day to help keep in check the breast cancer that has spread to other parts of her body. But while the medicine has helped send her cancer into remission, she may never be free of a financial obligation for the pricey drug.

Armstrong-Bolle, 68, paid $ 2,200 in January and February for the drug last year. When she entered the catastrophic coverage portion of her Part D plan, the cost dropped to $ 584 per month. Armstrong-Bolle’s husband died last year, and she used the money from his life insurance policy to cover her drug bills. This year, a patient assistance program has covered the first few months of coinsurance. That money will run out next month and she’ll owe her $ 584 portion again.

If she were getting traditional drug infusions instead of taking an oral medication, her treatment would be covered under Part B of the program and her coinsurance payments could be covered.

“It just doesn’t seem fair,” she said.

Kaiser Health News

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Silicon Valley techies are turning to a cheap diabetes drug to help them live longer

Doctors feel that taking metformin is mostly safe, but cautioned about the lack of clinical studies.
Health and Science

U.S.HEALTHCARE UPDATE:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

SPECIAL DONATION REQUEST UPDATE:

Please help American Consultants Rx achieve it’s biggest goal yet of donating over 30 million discount prescription cards to over 50k organizations in an effort to assist millions of Americans in need. Please click here to donate today!

UnitedHealth gives drug discounts directly to consumers in move beyond Trump crackdown

UnitedHealth says all of its new employer-sponsored plans in 2020 will pass discounts paid to so-called pharmacy benefits managers to consumers at the drug store.
Health and Science

U.S.HEALTHCARE UPDATE:

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Say What Now? Man Who Went Viral for Dropping $500 on Girl Scout Cookies Has Been ARRESTED in Long-Term Federal Drug Investigation

The man in a viral photo who spent more than $ 500 cash to buy 121 boxes of Girl Scout cookies so two Girl Scouts wouldn’t have to stand in the rain, has been arrested in a long-term federal drug investigation.

via NBC:

The photo went viral quickly, garnering nearly 10 thousand Facebook shares in 5 days with people praising the thoughtful gesture.

WSPA set out to cover the act of kindness Tuesday, interviewing both of the scouts and the woman who took the photo. However, late in the afternoon, WSPA learned that the mystery man, identified as Detric McGowan, was arrested Tuesday morning by the U.S. Drug Enforcement Agency (DEA).

He is accused of conspiracy to manufacture and distribute heroin, cocaine and fentanyl. McGowan allegedly tried to import drugs from Mexico.

According to the local DEA, McGowan was taken into custody at his home in a rural part of Laurens County, where cash and other assets were seized by U.S. Marshals.

Resident Agent Mike Rzepczynski of the DEA told 7-News Reporter Kirsten Glavin over the phone that McGowan’s arrest was part of a long-term federal drug investigation that began in September 2018 and spanned out of state.

McGowan faced a judge Tuesday afternoon, along with several others who were arrested in this operation. 

We’re told he will have a bond hearing on Friday.

McGowan remains in the custody of the U.S. Marshals.

According to the indictment, Detric McGowan has been charged with the following:

  • Conspiracy to possess with intent to distribute controlled substances,
  • Conspiracy to import controlled substances
  • Conspiracy to commit bulk cash smuggling ($ 1,004,665.00),
  • Interstate travel and transportation in aid of drug trafficking business,
  • Possession with intent to distribute and distribution of heroin,
  • Maintaining a drug-involved premise,
  • Conspiracy to structure transactions to evade reporting requirement
  • Three counts of unlawful use of a communication facility.

Yikes. Now we know why he was so comfortable dropping $ 500 on some cookies.

The post Say What Now? Man Who Went Viral for Dropping $ 500 on Girl Scout Cookies Has Been ARRESTED in Long-Term Federal Drug Investigation appeared first on lovebscott – celebrity news.

lovebscott – celebrity news

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Health and Science

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In Florida, Drug Re-Importation From Canada Finds New Champions, Old Snags

Florida Gov. Ron DeSantis said Wednesday he intends to bring down skyrocketing drug prices by leaning on an existing federal law that could enable the state to import prescription meds wholesale from Canada, where they’re much cheaper. He’s citing direct support from President Donald Trump, whose administration would have to approve the endeavor.

“He not only supports this, he is enthusiastic,” DeSantis said at a news conference northwest of Orlando.

But it’s not clear Florida’s idea has actually gotten that level of commitment.

The White House would not directly answer whether it supports letting states import prescription drugs from Canada and would not say whether it has blessed this proposal.

Instead, said spokesman Judd Deere, the president has asked his administration to “learn more details” about Florida’s drug-importation plan and “looks forward to educating Governor DeSantis on the many policy options the Trump administration has proposed to reduce costly drug prices for American families.” (Those policy options, according to a White House blueprint released last year, don’t include importation.)

“President Trump is always eager to discuss ways to lower drug prices for the American people,” Deere said.

Still, Florida is joining the growing ranks of states that, squeezed by climbing drug prices, are eyeing the Canadian fix. This idea isn’t new: Bernie Sanders, Vermont’s left-leaning independent senator, is among a number of longtime champions in Congress.

Legislation has been advanced this year in about a dozen states that would advance wholesale drug importation programs and a bill was introduced in Florida on the same day DeSantis outlined his support.

Vermont, Sanders’ home state, where a measure became law last year, leads the pack. But the state has not yet sought necessary federal approval.

And how much would these programs help anyway? While statehouses may be abuzz, in Washington, national politics impedes feasibility. And skeptics question how much relief these initiatives could actually provide.

“I don’t think large-scale importation — given both the size of the United States and the potential for retaliation [by the industry] — is likely to save as much as might be projected,” said Rachel Sachs, an associate law professor at Washington University in St. Louis, who tracks drug-pricing laws.

Said Ameet Sarpatwari, a lawyer and epidemiologist at Harvard Medical School, “Something like importation could help on the margins in the short term, but it needs to be coupled with some sort of strategy to be sure there is efficient supply in the market.”

In order to pursue this approach, states are leaning on a provision in a 2003 law that empowers the Department of Health and Human Services to approve state programs to import medications from Canada, as long as the state can show the practice is safe and saves money.

Once they gain this go-ahead, states would develop wholesale importation programs and then sell the drugs they get from up north to local pharmacies and hospitals, theoretically netting savings.

But HHS has never approved such a move. Last year, HHS Secretary Alex Azar told reporters that importation proposals constituted a “gimmick” rather than any meaningful drug-pricing reform. Vermont plans to formally submit its importation proposal this summer. So far, HHS has been silent on that project.

Last June, though, Azar directed the Food and Drug Administration to establish a working group to study how drug re-importation could help address price hikes and supply disruptions.

DeSantis on Friday acknowledged that he doesn’t yet have the backing of federal agencies needed to make his plan go forward.

The guarantee of drug safety is also a challenge. HHS secretaries from both Republican and Democratic administrations have argued over the years that they could not find a process that meets this standard — though many pharmaceutical policy experts dispute this argument. Sarpatwari called it “a red herring.”

Policy researchers question whether these proposals would net substantial savings — or even survive the backlash from the powerful pharmaceutical industry.

“If you think about the practicalities of trying to feed a large section of the U.S. market from Canada, it doesn’t make much sense,” argued Michael Law, a pharmaceutical policy expert and associate professor at the University of British Columbia’s Centre for Health Services and Policy Research. “There are too many steps along the way where people will shut it down.”

Pharmaceutical companies supplying Canadian wholesalers will quickly notice, he said, if those entities are buying lots more drugs and then selling them back to Americans. And they would cut off supplies pretty quickly.

That’s especially true, Law added, for a state as big as Florida, whose population of 20 million people is not that far from rivaling Canada’s 37 million.

Importation would also face a formidable opponent from the Canadian government, both he and Sachs said. If Canadian prices are used to bring down American prices, drugmakers have a reason to just charge more up north.

Vermont estimated potential savings of between $ 1 million and $ 5 million. Those figures don’t account for the costs of setting up the program.

Even with those issues, though, there’s active interest in the idea — just ask DeSantis’ own constituents. A number of employers and local governments in Florida have been buying drugs from Canada for years. Among them: the Pasco County school district near Tampa.

“The program is working well, and we’ve had no issues or complaints,” said Patricia Howard, an employee benefits official with the school system.

In Florida, as around the country, some businesses also already help consumers purchase drugs from overseas, and they say they see sizable savings.

Tim Booth, owner of Canadian Meds in Lady Lake, Fla., said his customers get prescriptions filled from pharmacies in Canada, Australia, Britain and India. “We get many doctor referrals who fax us prescriptions for their patients,” he said.

Canadian Meds, which is located about eight miles from where DeSantis made his prescription drug announcement, is one of about 20 such storefront businesses across Florida that claim thousands of customers each year. These businesses, which technically operate outside the law, started in 2003 and continue with little pushback from regulators.

“Everybody knows drug prices are too high, so anything they can do is good for the American public,” Booth said.

But the benefits Booth’s customers see may not translate to a statewide program, considering the differences between thousands of customers versus a statewide program. Plus, the federal law that DeSantis’ plan would use authorizes importation only from Canada — not Australia, Britain or India.

That said, proposals like these have political implications, both in states, whose budgets are directly squeezed by climbing drug prices, and in Washington, where drug pricing is one area where congressional activity seems more likely.

“This goes along with a broader thinking that’s going on about how to lower drug prices in the United States,” Law said. “Despite the fact that this might not work — it’s not too long before someone figures out something that would.”

Kaiser Health News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Winners And Losers Under Bold Trump Plan To Slash Drug Rebate Deals

Few consumers have heard of the secret, business-to-business payments that the Trump administration wants to ban in an attempt to control drug costs.

But the administration’s plan for drug rebates, announced Thursday, would end the pharmaceutical business as usual, shift billions in revenue and cause far-reaching, unforeseen change, say health policy authorities.

In pointed language sure to anger middlemen who benefit from the deals, administration officials proposed banning rebates paid by drug companies to ensure coverage for their products under Medicare and Medicaid plans.

“A shadowy system of kickbacks,” was how Health and Human Services Secretary Alex Azar described the current system in a Friday speech.

The proposal is a regulatory change applying only to Medicare plans for seniors and managed Medicaid plans for low-income people. But private insurers, who often take cues from government programs, might make a similar shift, administration officials said.

Drug rebates are essentially discounts off the list price. Outlawing them would divert $ 29 billion in rebates now paid to insurers and pharmacy benefit managers into “seniors’ pocketbooks at the pharmacy counter,” Azar said.

The measure already faces fierce opposition from some in the industry and is unlikely to be implemented as presented or by the proposed 2020 effective date, health policy analysts said.

In any event, it’s hardly a pure win for seniors or patients in general. Consumers are unlikely to collect the full benefit of eliminated rebates.

At the same time, the change would produce uncertain ricochets, including higher drug-plan premiums for consumers, that would produce new winners and losers across the economy.

“It is the most significant proposal that the administration has introduced so far” to try to control drug prices, said Rachel Sachs, a law professor at Washington University in St. Louis. “But I’m struck by the uncertainty that the administration has in what the effects would be.”

Possible Winners:

Chronically ill patients who take lots of expensive medicine

The list price for many brand-name medicines has doubled or tripled in recent years. But virtually the only ones affected by the full increases are the many patients who pay cash or whose out-of-pocket payments are based on the posted price.

By banning rebates, the administration says its intention is to ensure discounts are passed all the way to the patient instead of the middlemen, the so-called pharmacy benefit managers or PBMs. That means consumers using expensive drugs might see their out-of-pocket costs go down.

If rebates were eliminated for commercial insurance, where deductibles and out-of-pocket costs are generally much higher, chronically ill patients could benefit much more.

Drug companies

Ending rebates would give the administration a drug-policy “win” that doesn’t directly threaten pharmaceutical company profits.

“We applaud the administration for taking steps to reform the rebate system” Stephen Ubl, CEO of PhRMA, the main lobby for branded drugs, said after the proposal came out.

The change might also slow the soaring list-price increases that have become a publicity nightmare for the industry. When list prices pop by 5 or 10 percent each year, drugmakers pay part of the proceeds to insurers and PBMs in the form of rebates to guarantee health-plan coverage.

No one is claiming that eliminating rebates would stop escalating list prices, even if all insurers adopted the practice. But some believe it would remove an important factor.

Possible Losers:

Pharmacy benefit managers

PBMs reap billions of dollars in rebate revenue in return for putting particular products on lists of covered drugs. The administration is essentially proposing to make those payments illegal, at least for Medicare and Medicaid plans.

PBMs, which claim they control costs by negotiating with drugmakers, might have to go back to their roots — processing pharmacy claims for a fee. After recent industry consolidation into a few enormous companies, on the other hand, they might have the market power to charge very high fees, replacing much of the lost rebate revenue.

PBMs “are concerned” that the move “would increase drug costs and force Medicare beneficiaries to pay higher premiums and out-of-pocket expenses,” said JC Scott, CEO of the Pharmaceutical Care Management Association, the PBM lobby.

Insurance companies

Insurers, who often receive rebates directly, could also be hurt financially.

“From the start, the focus on rebates has been a distraction from the real issue — the problem is the price” of the drugs, said Matt Eyles, CEO of America’s Health Insurance Plans, a trade group. “We are not middlemen — we are your bargaining power, working hard to negotiate lower prices.”

Patients without chronic conditions and high drug costs

Lower out-of-pocket costs at the pharmacy counter would be financed, at least in part, by higher premiums for Medicare and Medicaid plans paid by consumers and the government. Premiums for Medicare Part D plans could rise from $ 3.20 to $ 5.64 per month, according to consultants hired by the Department of Health and Human Services.

“There is likely to be a wide variation in how much savings people see based on the drugs they take and the point-of-sale discounts that are negotiated,” said Elizabeth Carpenter, policy practice director at Avalere, a consultancy.

Consumers who don’t need expensive drugs every month could see insurance costs go up slightly without getting the benefits of lower out-of-pocket expense for purchased drugs.

Other policy changes giving health plans more negotiating power against drugmakers would keep a lid on premium increases, administration officials argue.

Kaiser Health News

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Health and Science

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Podcast: KHN’s ‘What The Health?’ Drug Prices Are Rising Again. Is Someone Going To Do Something About It?

Many drugmakers have announced price increases with the start of the new year. The new Congress wants to do something about that. And even though both Republicans and Democrats want to address the politically potent issue of drug prices, it is unclear what they might be able to agree on.

Battle lines are forming between the House and Senate on the matter of abortion. The House is led by abortion-rights supporters and, since the election, the Senate has become slightly more against abortion.

And even though the majority of the Department of Health and Human Services remains unaffected by the partial government shutdown, the lapse of funding for other agencies is having spillover effects on health programs.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Alice Ollstein of Politico.

Among the takeaways from this week’s podcast:

  • The biggest conflict among Republicans and Democrats on the drug issue centers on the GOP’s reluctance to give the government a role in directly negotiating prices. Adding to the pressure is the clear indication that the issue will be front and center in the 2020 campaign.
  • Some states, such as California, are looking to find ways to bring down drug costs on their own. California Gov. Gavin Newsom, a Democrat, has proposed that the state have direct negotiations with drugmakers. Such efforts could mean cutting off consumers’ access to some drugs, if manufacturers don’t agree to a price the state likes, and that is a painful choice for officials and patients.
  • When House committee assignments were released this week, women were appointed to lead many of the key panels that have a hand in health policy, including the chairman and top Republican on the Appropriations Committee and two Energy and Commerce subcommittees.
  • The House Democratic Caucus now has more liberal members and fewer conservatives, so the party’s efforts to roll back restrictions on abortion are likely to be more robust. That could also trigger some big battles with Republicans through the legislative session.
  • Senate Majority Leader Mitch McConnell (R-Ky.) is putting a bill on the Senate floor that would make permanent the Hyde Amendment — which bars federal funding of abortions in nearly all circumstances. But it seems unlikely that bill could be passed by the Senate, where it needs 60 votes, and even some Republicans are believed to oppose it.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: Bloomberg News’ “This JPMorgan Health Conference Is So Packed Attendees Are Meeting in the Bathroom,” by Kristen V Brown

Joanne Kenen: The New York Times’ “The Strange Marketplace for Diabetes Test Strips,” by Ted Alcorn

Margot Sanger-Katz: Kaiser Health News’ “Patients Turn To GoFundMe When Money And Hope Run Out,” by Mark Zdechlik

Alice Ollstein: The Washington Post’s “Federal Officials Launch Audit of D.C. Government’s Opioid Grant Spending,” by Peter Jamison

Kaiser Health News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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HQ Trivia and Vine co-founder Colin Kroll dead at 34 of apparent drug OD

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Technology News & Reviews | New York Post

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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $ 147,308 in 2017 compared with $ 30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $ 5.4 billion in sales and $ 184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $ 10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Drug overdoses, suicides cause drop in 2017 US life expectancy; CDC director calls it a ‘wakeup call’

Life expectancy in the United States declined from 2016 to 2017, yet the 10 leading causes of death remained the same, according to three government reports released Thursday. Increasing deaths due to drug overdoses and suicides explain this slight downtick in life expectancy, the US Centers for Disease Control says.


CNN.com – RSS Channel – Health

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New Congress To Tackle Burning Health Care Issues, Including Drug Prices

Voters ranked health care as the top issue facing the country after the midterms, according to CBS News exit polling. KHN senior correspondent Sarah Jane Tribble joined “Red and Blue” anchor Elaine Quijano to discuss how Republicans and Democrats are responding to the American public’s call to action — with a focus on skyrocketing prescription drug prices. Tribble and Quijano also explored how the midterms bolstered Medicaid expansion in a handful of states.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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SPECIAL NEWS BULLETIN:

http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Esperion CEO: Our new cholesterol drug can help millions of patients

Shares of Esperion popped on the company's latest data for its cholesterol drug.
Health and Science

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Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

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Could Trump’s plan for lowering prescription drug prices work?

Trump proposed having Medicare base what it pays for some expensive drugs on average prices in other industrialized countries, such as France and Germany.
ABC News: Health

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Novartis drug cut death risk by 35 percent in gene mutation breast cancer

An experimental cancer drug that Novartis hopes will raise the profile of its oncology portfolio cut the risk of death or disease progression by more than a third in breast cancer patients with a hard-to-target gene mutation.


Reuters: Science News

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Trump Adds A Global Pricing Plan To Wide Attack On Drug Prices, But Doubts Persist

President Donald Trump’s new pledge to crack down on “the global freeloading” in prescription drugs had a sense of déjà vu.

Five months ago, Trump unveiled a blueprint to address prohibitive drug prices, and his administration has been feverishly rolling out ideas ranging from posting drug prices on television ads to changing the rebates that flow between drugmakers and industry middlemen.

Thursday, Trump proposed having Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries, such as France and Germany, where prices are much lower. The proposal is in the early stages of rule-making and awaiting public comments.

The U.S., Trump said, will “confront one of the most unfair practices, almost unimaginable that it hasn’t been taken care of long before this.”

The proposal was met with hope and skepticism, with several experts saying they were happy the administration was taking on Medicare Part B’s rising drug prices but questioning its approach.

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said in an online post that the administration’s proposed solutions were unclear. And, he said, they would “face insurmountable challenges.”

While some industry watchers pointed to the announcement as a political move, Wells Fargo pharmaceutical analyst David Maris said that this is a broader effort by the president and his administration to attack the root causes of high drug prices.

“The reality is he could very easily not take this on and do what other administrations have done and let the prices keep rising.”

Trump, too, promised more to come and said he will soon announce “some things that will really be tremendous.” On Friday, Health and Human Services Secretary Alex Azar said that, as promised in the blueprint, there would be more changes to Medicare Part D, which covers most prescriptions. Ian Spatz, a public policy expert and senior adviser at Manatt Health, said the overall blueprint was “unprecedented in terms of how many different ideas and areas of ideas that it contained.”

Nothing would happen overnight. The proposal to require drug prices in TV ads could be delayed by litigation and notably, if implemented, does not include any penalties for companies who fail to post their prices.

The proposed rebate rule was delivered to the Office of Management and Budget in July. Matt Brow, president of industry consulting firm Avalere Health, said he expects the administration to publish the rule for comment by year’s end.

Trump’s international pricing plan is not as far along as the rebate proposal. Rather, it is an “advanced notice of proposed rule-making.” The proposed rule could come in spring 2019, and Azar said the new model could begin in late 2019 or early 2020.

Yet, on Friday, Azar signaled the proposal could change, telling an audience at the Brookings Institution that the administration is “open to any number of alternative ideas.”

Avalere’s Brow said there is a good chance the proposal will change significantly.

“The sweeping nature of the proposal makes the stakes higher and makes it harder to implement,” Brow said.

If the administration moves forward, it would bypass Congress and implement a pilot under the Center for Medicare & Medicaid Innovation’s purview. The pilot would phase in over five years and apply to 50 percent of the country. Azar said there would be no changes to Medicare benefits and no restrictions on patient access.

The proposal focuses on drugs covered under Medicare Part B, which are administered in hospitals, clinics and doctors’ offices. It also would alter the reimbursement formula for doctors and providers and would allow private-sector vendors to purchase drugs and then sell them to doctors and hospitals. Medicare would reimburse those vendors at the international pricing level.

Currently, doctors and hospitals administering Part B drugs are reimbursed the average price of a drug plus 6 percent. President Barack Obama’s administration attempted to alter Part B as well but drew intense lobbying opposition and eventually withdrew a proposed pilot project.

Allan Coukell, senior director for health programs at Pew Charitable Trusts, said removing incentives that reward doctors for purchasing costlier drugs and bringing in a new way to control prices “makes a lot of sense.” Drug spending within Medicare Part B reached $ 22 billion in 2015, and drug costs have increased by an average of 8.6 percent annually since 2007.

Stephen Ubl, president of the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said imposing foreign price controls from countries with socialized health care systems would harm patients and hinder drug discovery and development.

Azar, a former executive at pharmaceutical manufacturer Eli Lilly, told reporters Thursday that “you may hear the tired talking points” that this will affect innovation. He disputed that idea, concluding that “less than 1 percent of pharma [research and development] could potentially be impacted by this change.”


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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Kaiser Permanente Southern California Provides Numerous Drop-Off Locations for National Prescription Drug Take Back Day

PASADENA, Calif. — Kaiser Permanente Southern California facilities, in partnership with local law enforcement agencies, are encouraging community members to participate in “National Prescription Drug Take-Back Day” on Saturday, October 27, 2018, from 10:00 a.m. to 2:00 p.m.

“At Kaiser Permanente we remain actively involved in the total health of our Southern California community, and we feel it’s our responsibility to educate the community about the importance of responsibly disposing prescription drugs, while also raising awareness of the significant harm that comes from abuse of medications, “said Alan Kiyohara, vice president, Pharmacy Operations and Services for Kaiser Permanente Southern California. “Studies have shown that medicines that remain in the home are highly susceptible to misuse.”

DEA National Rx Take Back - Saturday, October 27 10 a.m. to 2 p.m. Visit deatakeback.com for more information.There are 16 Kaiser Permanente Southern California facilities participating as drop-off sites for Take Back Day. Earlier this year, 11 Kaiser Permanente facilities participated during the Take Back Day, where more than 6,700 pounds of unused and expired medications were collected.

These prescription drug take back events address vital public safety and public health issues while providing residents with a convenient and anonymous way to safely dispose of expired, unwanted, or unused medicines.

Rates of prescription drug abuse in the U.S. are alarmingly high, as are the number of accidental poisonings and overdoses due to these drugs. According to the Drug Enforcement Administration, more people started down the path of addiction through the misuse of opioid prescription drugs, and each year higher amounts of opioids are being turned in at the Take Back Day events.

Those unable to participate on October 27 can properly dispose of medications at drug disposal kiosks in Kaiser Permanente facilities throughout Southern California. Kiosks are available at Kaiser Permanente locations for public use during regular service hours.

A listing of additional drop-off locations available for public use can be found on the Drug Enforcement Administration website.


About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.

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NEW PARENT ESSENTIAL UPDATE:

Trump outlines new plan to lower Medicare drug prices, end ‘rigged’ system

Under the administration's proposal, the Department of Health and Human Services would permit Medicare to create a new payment model that would bring drug prices in line with what other nations pay.
Health and Science

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AbbVie rheumatoid arthritis drug succeeds in late stage trial

AbbVie Inc on Tuesday said its experimental rheumatoid arthritis (RA) treatment showed significant improvement in physical function, pain and quality of life compared with the commonly prescribed generic drug methotrexate in a late stage clinical trial.


Reuters: Science News

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10.24.18 Where to buy toys for Christmas; Mobile check deposit rules; Prescription drug price disclosure

With Toys R Us having gone bankrupt, Clark discusses how to approach toy shopping for Christmas; Mobile check depositing is a gift from above. But some folks are abusing this gift and new rules about how you can deposit mobile checks are coming to a banking app near you; Prescription drug companies might have to disclose their drug prices on TV ads in the near future.

Learn more about your ad choices. Visit megaphone.fm/adchoices

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clark.com

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Amgen cuts price of cholesterol drug by almost 60%, echoing rival’s move

Biotech giant Amgen is lowering the price of its cholesterol medicine Repatha by almost 60 percent, following a similar move from its competitor, after both drugs failed to meet sales expectations.
Health and Science

U.S.HEALTHCARE UPDATE:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

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‘To some, Maddie was just a junkie’: Obituary gives new take on drug addiction

Madelyn Linsenmeir, 30, died after years of battling drug addiction.
ABC News: Health

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

BEST DEAL UPDATE BY AMERICAN CONSULTANTS RX:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

SPECIAL DONATION REQUEST UPDATE:

Please help American Consultants Rx achieve it’s biggest goal yet of donating over 30 million discount prescription cards to over 50k organizations in an effort to assist millions of Americans in need. Please click here to donate today!

National Prescription Drug Take Back Day Southern California Drop-Off Locations

Location Event Time

Kaiser Permanente Los Angeles Medical Center

4760 Sunset Blvd, Los Angeles, CA 90027

Drop-off site located curbside

10 a.m. to 2 p.m.

Kaiser Permanente West Los Angeles Medical Center

6041 Cadillac Ave, Los Angeles, CA 90034

Drop-off site located at the 24-Hour Pharmacy turn-around

10 a.m. to 2 p.m.

Kaiser Permanente Panorama City Medical Center

13652 Cantara Street, Panorama City, CA 91402

Drop-off site located outside the Medical Offices 3

10 a.m. to 2 p.m.

Kaiser Permanente Woodland Hills Medical Center

5601 De Soto Ave, Woodland Hills, CA 91367

Drop-off site located at parking lot on the corner of De Soto Ave and Burbank Blvd

10 a.m. to 2 p.m.

Kaiser Permanente Anaheim Medical Center

3460 E. La Palma Ave, Anaheim, CA 92806

Drop-off site located at turn-around driveway of Kraemer Medical Office Building 1

10 a.m. to 2 p.m.

Kaiser Permanente Irvine Medical Center

6670 Alton Parkway, Irvine, CA 92618

Drop-off site located at turn-around driveway of Alton/Sand Canyon Medical Office Building 1

10 a.m. to 2 p.m.

Kaiser Permanente South Bay Medical Center

25825 South Vermont Ave, Harbor City, CA 90710

Drop-off site located in front of Parkview Building near the corner of Vermont Ave and Pacific Coast Highway

10 a.m. to 2 p.m.

Kaiser Permanente Riverside Medical Center

10800 Magnolia Avenue, Riverside, CA 92505

Drop-off site located in parking Lot B4 at corner of Magnolia Ave and Park Sierra Ave

10 a.m. to 2 p.m.

Kaiser Permanente Stockdale Medical Office Building

3501 Stockdale Highway, Bakersfield, CA 93309

Drop-off site located in the parking lot

10 a.m. to 2 p.m.

Kaiser Permanente Bellflower Medical Offices

9400 E. Rosecrans Ave. Bellflower, CA 90706

Drop-off site located in the circle area near Clark Ave. entrance

10 a.m. to 2 p.m.

Kaiser Permanente Baldwin Park Medical Center

1011 Baldwin Park Blvd, Baldwin Park, CA 91706

Drop-off site located near patient drop-off (medical center entrance)

10 a.m. to 2 p.m.

Kaiser Permanente Diamond Bar Medical Offices

1336 Bridgegate Dr, Diamond Bar, CA 91765

Drop-off site located near main entrance

10 a.m. to 2 p.m.

Kaiser Permanente San Marcos Medical Offices

400 Craven Road, San Marcos, CA 92078

Drop-off site located at Entrance C off Craven Road

10 a.m. to 2 p.m.

Kaiser Permanente Otay Mesa Medical Offices

4650 Palm Ave., San Diego, CA 92154

Drop-off site located at the east entrance of the campus

10 a.m. to 2 p.m.

Kaiser Permanente Fontana Medical Center

9961 Sierra Ave, Fontana, CA 92335

Drop-off site located curbside by the parking lot of Medical Office Building 4

10 a.m. to 2 p.m.

Kaiser Permanente Ontario Medical Center

2295 S. Vineyard Ave, Ontario, CA 91761

Drop-off site located curbside by the parking lot of Medical Office Building B

10 a.m. to 2 p.m.

 

 

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Trump administration may soon require drugmakers to advertise drug prices, report says

The proposal is slated to be introduced next week, Politico reported, citing four people with knowledge of the plan. It's a key piece of President Donald Trump's blueprint to lower drug prices, which the administration unveiled in May. 
Health and Science

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Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

SPECIAL DONATION REQUEST UPDATE:

Please help American Consultants Rx achieve it’s biggest goal yet of donating over 30 million discount prescription cards to over 50k organizations in an effort to assist millions of Americans in need. Please click here to donate today!

A man drank too much of an erectile dysfunction drug. It tinted his vision red

A man drank too much of an erectile dysfunction drug purchased over the internet and it tinted his vision red, USA Today reports. Doctors have been unable to fix it.
Health and Science

U.S.HEALTHCARE UPDATE:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

SPECIAL DONATION REQUEST UPDATE:

Please help American Consultants Rx achieve it’s biggest goal yet of donating over 30 million discount prescription cards to over 50k organizations in an effort to assist millions of Americans in need. Please click here to donate today!