David Sirota’s blog “The Lever” is a source of excellent investigative reporting. It recently revealed that President Biden is taking on Big Pharma. Some advocates said he needed to go further, but this is a huge opening move to establish the principle that the federal government may cap the prices of drugs developed with public money. The following was written by Katy’s Schwenk.
White House Takes On Pharma Patents
The White House plans to exercise its authority to lower the price of costly medications that were developed with public funding — a potentially powerful new tool in the battle against sky-high medication prices.
The Biden administration announced last week that it had concluded, after a months long review, that it had the authority to break the patents of drugs developed with public funding if their cost was too high. This authority — dubbed “march-in rights” — has never been used, and is likely to encounter major pushback from Big Pharma.
Take, for instance, the case of the drug Xtandi, which is used to treat prostate cancer. The drug was developed at the public University of California, Los Angeles, using federal funding from the National Institutes of Health and the U.S. Army. The university then licensed the drug to a pharmaceutical company called Medivation, which is now owned by Pfizer, and the Japanese pharmaceutical behemoth Astellas. Pfizer and Astellas have made billions selling the drug worldwide. In the U.S., Xtandi costs on average $190,000 a year, more than five times higher than in Canada and Japan.
The Bayh-Dole Act, which was passed more than 30 years ago, allows the federal government to use march-in rights to intervene if drugs developed with public money are not being made accessible to the public. Despite Xtandi being more or less a perfect case for the use of this authority — a cancer drug developed with public money being sold at an egregious premium — the Biden administration declined to use march-in rights in March to seize the patent and allow a generic competitor to enter the market, forcing down the drug’s cost.
Since then, though, federal officials have been reviewing march-in authority. And now, the White House’s announcement signals that they may begin using it to fight drug profiteering.
While the announcement is a critical step forward, the White House’s framework has still drawn some blowback from some advocacy groups for being less aggressive than it could be. In this week’s announcement, the Biden administration implied it would exercise march-in rights only in the most extreme cases of price gouging by Big Pharma. “Where most drug prices already are egregious and force rationing, few drugs will seem ‘extremely’ priced by comparison,” argued the consumer advocacy group Public Citizen.
But even the prospect of limited use of march-in rights has stoked fear in the pharmaceutical industry, which is spending more than ever to oppose drug pricing reforms. Industry groups have already declared their opposition to the measure. It’s a sign of how much is at stake for Big Pharma — and for those paying a premium for life-saving medication.
Diane Ravitch's blog 
Great decision.
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I just had the experience of being prescribed a drug that I cannot afford. My doctor thinks this the best treatment for me and told me that I would have a zero dollar copay. My insurance company just posted a copay that is out of my reach. So, I will go without it. That’s the way it is in the United States, that exceptional country.
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I thought you loved your MA plan? Your situation is a shining example of why people should not drop their current plan for a MA plan.
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It would be exactly the same on straight Medicare. Exactly the same. It’s a Tier 3 drug.
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Medicare does not cover the cost of prescription drugs.
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Medicare Part D covers prescription drugs.
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What I’m looking at is the standard Medicare copay for this drug.
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Medicare part D does cover drugs. Also, lots of secondary insurances will have Rx coverage and Seniors then don’t have to worry about paying for the Part D. Medicare Advantage plans like to tout “drug coverage” as a benefit…..until they don’t want to cover the cost of a particular Rx that a Dr. has ordered. MA wants patients to have to jump through so many hoops that they give up and go without. Cost saving is the goal.
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Until now, my drugs have been slightly less under my Medicare Advantage plan than they were under Medicare Part D. Very slightly. I have a zero-dollar copay for Tier 1 drugs. Under Medicare Part D, these were $7.00 for a 3-month’s supply. I am investigating what the deal is with the cost of this Tier 3 drug.
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Likely, not on the formulary. You will likely be able to get your Rx by jumping through “the hoops”. It may be that you have to try 2-3 different drugs, with no success, before the ins. co will approve “the best” drug to treat your condition. It may be that they just want your Dr. to waste his precious time (or his secretary/office worker/biller) writing letters or holding on the phone listening to the dreaded Muzak for approval?
I used to be a medical secretary/surgery scheduler/billing coder and even 20+ years ago this was an ongoing problem with regular insurance (Not Medicare). The injustices done to sick and elderly people by insurance companies made me seethe in anger. I learned how to work “the system” and it made my job quite difficult daily, but my patients got what they needed most of the time.
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Thanks, Lisa. I shall hammer away at it! Your thoughtful advice, based on relevant experience, is much appreciated.
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Medicare Part D is a private medigap plan offered by private insurance. The tier is set by the insurer not the government. The insurer must have to follow stricter guidelines than the Advantage private insurance.
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All my life I paid into Medicare, and I thought that when I retired, I would have this insurance. Little did I know that I would pay handsomely every month for it and that it would consist of a labyrinthine set of providers and rules that even someone like me, who is pretty smart and able to read and research prodigiously cannot get a grip on. And, the info provided by the government to new enrollees is clear as a waste pond at an industrial pig farm. It’s a disgrace.
And here we are, in the wealthiest country in the history of the world, and MOST of our elderly don’t have catastrophic health care or ANY kind of dental care, and so they are basically F—–d.
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“…labyrinthine set of providers and rules …”
Especially if you have to go with a Medicare Advantage policy, which is ,of course, NOT MEDICARE. It’s just cheaper up front until you need services then the fun trying to get those services begins. If they would get rid of “Advantage” products, Medicare would be cheaper because everybody would be in the same pool.
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You forget, Speduktr, that the reason why Medicare Part D is provided by private insurers is because Medicare itself doesn’t cover drugs and lots and lots of other care. For example, every insurance plan I have ever had covers a once-a-year complete physical, including extensive bloodwork. This is an essential part of preventative care. But Medicare covers only what it calls a once-a-year “wellness check,” which is basically the doctor listening to your lungs with a stethoscope and looking into your eyes, mouth, and ears. Horrible. Standard Medicare is HORRIBLE. And it does not cover ANY dental. And, again, it doesn’t cover drugs. One has to buy some sort of private extension–Medigap or Medicare Advantage or something.
This ought to be a national scandal.
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I switched to my Medicare Advantage Plan because it offered a $0 copay for almost all the drugs I take, instead of a $7 copay under my Medicare Part D plan. And, a hospital stay (one night) that I had would have cost a little over $400 under my Advantage Plan, instead of the $1,400 it cost me under standard Medicare. So far, Medicare Advantage has paid for a sleep study for me and a colonoscopy. Charge to me for each: $40. I am a Type 2 diabetic and take Metformin and insulin. My cost: $30 a month. Thank you Joe Biden and the Democrats in Congress for that.
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I am hoping that Biden will force big pharma’s hand with this new idea to lower costs through using that law that allows the government to prohibit excessive profits for drugs developed with tax payer money. My drug co-pays tend to be really low but one puts me in that donut hole every year where I have to pay more of the cost. the drug company has gotten around the generic challenge by tweaking the patent. I have heard a generic is supposed to happen in ’24. I’ll believe it when I see it.
I never thought I would sound so old!! Too many conversations start with, “How are you feeling?”
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IKR? It astonishes me to look at all the pill bottles on my dresser! And, alas, a drug that my doctor says I should take is out of my reach. Under Medicare or Medicare Advantage.
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Glad it works for you, Bob.
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So far, but the comments here give me pause.
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I seriously doubt that you diidn’t thoroughly research your options, Bob. I am so glad the annual enrollment period is over! Every other commercial on TV was for someone’s Advantage plan.
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Yes, my poor mail carrier was weighed down by all those solicitations!!! And, ofc, I started hearing from the AARP about 20 years ago. Tons of trees downed for this.
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And Merry, Happy whatever it is you celebrate, Speduktr!
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Thank you, Bob. We just got back from a Christmas Eve dinner with family. If nothing else, Christmas provides a reason for gathering with family and friends. I hope you have the chance to partake in the best of the holidays traditions.
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I have been cooking most of the week for tomorrow’s Christmas feast.
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We decided not to do traditional holiday fare. Instead, we are going to eat Italian for our family dinner. So, I made (from scratch),
Bob’s Better than Bobby Baccalieri’s Baked Ziti
Pasta Puttanesca
Pasta Parma Rosa with Meatballs
Fettucini Alfredo
Ancient grains garlic and fennel breadsticks
Panattone
Mozzarella (homemade)
Italian and Russian tea cakes
Madeleines (OK, France is not too far from Italy)
Peanut cake with vanilla buttercream frosting
Homemade lemonade
All, again, from scratch, except that I am using dry pasta from the store this time. There was simply so much to do and so big a crowd that I made this concession (though ordinarily, I love making pasta). The peanut cake and lemonade perhaps require some explanation. Living in the rural South mostly off what the farm could provide, my Grandmother on my mother’s side did the best with what she had on hand, which included peanuts and lemons. LOL. So, my daughter insists that every Christmas dinner include this homage to Grandma Sarah.
Exhausted but looking forward to seeing the grandkids. Merry Christmas, everyone.
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Bob, what a wonderful feast!!
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A wonderful spiral cut honey glazed ham for us, and dessert was my mother-in-law’s chocolate mousse, which is to die for. Every year my sister-in-law makes it, and Mom is there again.
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I really have to profread before hiting send!
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I also made, for this dinner, cultured butter and a spice mix to go in olive oil for dipping the breadsticks. In that spice mix: garlic, salt, fennel, rosemary, thyme, oregano, paprika, sumac, dried chile de arbol.
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When I spoke of a “labyrinthine set of providers and rules,” I was talking about standard Medicare. The options and rules involved–what’s covered and what’s not, for example–are Byzantine. I’m a skilled communicator and researcher. I found figuring out what was best for me to do re: my care at this age IMPOSSIBLE. It was all clear as mud.
And that’s because our system is all about protecting the profits of the U.S. healthcare industry, which makes huge donations to Congress to keep things that way. It’s obscene.
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…our system is all about protecting the profits of the U.S. healthcare industry, which makes huge donations to Congress to keep things that way.”
That we can agree on. Medicare has never denied any of our claims, nor has our medigap. I don’t think they can if Medicare pays its share (80%). Finding that gap and drug plan was easy for us. We went with a provider from our private insurance days that had been reliable. I knew about some to avoid from school benefit plan days, too. It was easy to figure if they were less than helpful before Medicare they would be no better after Medicare eligibility kicked in. Plus, I have never had to deal with a limited number of providers. I know many people have no choice but to go with an advantage plan, and I do have a friend who can’t afford even basic Medicare coverage, so bring on universal coverage!
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One of the things that drove me to Medicare Advantage was having Medicare deny services. I was sick of hearing, “Sorry, that’s not covered.”
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Should drug dealers be given federal assistance to engage in price gouging? Just Say No.
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Biden is finally using an old law to curb the extreme profiteering of Big Pharma. So many Americans cannot afford the price of prescription medicines. American taxpayers often underwrite the R&D of life saving drugs. However, when the drugs come out, most working people cannot afford to pay for the outrageous price of the drugs. People in the EU often pay less for drugs because the EU has stepped in to regulate the excessive profiteering. Medical debt in this country is a major problem. Hopefully, Biden’s decision will make more drugs affordable for people.
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I think I heard that medical debt is the major cause of bankruptcy.
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The Organisation for Economic Co-operation and Development (OECD; French: Organisation de coopération et de développement économiques, OCDE) is an intergovernmental organisation with 38 member countries–roughly the rich countries of the world with developed, successful economies. The following figures are a bit old, but they haven’t changed much:
All other countries in the OECD have universal coverage.
Heatlhcare systems by type, 2013, from World Health Organization
“Thirty-two of the thirty-three developed nations have universal health care, with the Untied States being the lone exception.”
citation: Praveen Ghanta, “List of Countries with Universal Healthcare.” True Cost: Analyzing Our Economy, Government Policy, and Society through the Lens of Cost-Benefit, 2013. https://truecostblog.com/2009/08/09/countries-with-universal-healthcare-by-date/. Accessed April 9, 2019.
The US has the highest healthcare costs in the OECD
Healthcare costs in the United States, from National Center for Health Statistics, Centers for Disease Control and Prevention
$10,348 per capita (per person), 2016
Total expenditure, $3.3 trillion, 2016
Healthcare as percent of Gross Domestic Product: 17.9 %
Citation: “Health Expenditures.” National Center for Health Statistics, Centers for Disease Control and Prevention, 2016. https://www.cdc.gov/nchs/fastats/health-expenditures.htm. Accessed April 9, 2019.
Costs for countries in the OECD is much lower on average:
Average healthcare cost per capita, 2018: $4,069 USD
Average cost of healthcare as a percentage of Gross Domestic Product in the OECD, 2018: 8.9 %
Highest percentages: US at 17.2 % of GDP, Switzerland at 12.3 % of GDP, France at 11.5 % of GDP (2018 figures)
Citation: “Spending on Health: Latest Trends.” OECD, June 2018. http://www.oecd.org/health/health-systems/Health-Spending-Latest-Trends-Brief.pdf. Accessed April 9, 2019.
So, we pay twice as much.
Despite this, our health outcomes are worse:
Comparing health outcomes, life expectancy
Life expectancy of the following OECD countries is higher than in the US: Chile, Costa Rica, Portugal, Slovenia, Finland, Germany, Greece, Belgium, Denmark, France, Austria, Korea, United Kingdom, Canada, Ireland, Netherlands, New Zealand, Luxembourg, Australia, Iceland, Span, Sweden, Israel, Norway, Italy, Japan, Switzerland (2017 figures)
Citation: “Life Expectancy at Birth.” OECD Data, 2017. https://data.oecd.org/healthstat/life-expectancy-at-birth.htm#indicator-chart. Accessed April 9, 2019.
Comparing health outcomes, infant mortality
Infant morality rates in the following OECD countries are lower than in the US: Iceland, Finland, Japan, Slovenia, Norway, Estonia, Sweden, Spain, Czech Republic, Italy, Korea, Ireland, Australia, Austria, Demark, Israel, Belgium, Portugal, Germany, Netherlands, Switzerland, France, Latvia, Luxembourg, United Kingdom, Hungary, Poland, Greece, Lithuania, Canada, Slovak Republic, New Zealand (2017 figures)
Citation: “Infant Mortality Rates.” OECD Data, 2017. https://data.oecd.org/healthstat/infant-mortality-rates.htm#indicator-chart. Accessed April 9, 2019.
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So, the US pays twice as much for healthcare, per capita, as the average in the OECD, but we have far worse outcomes. And we have these insane pharmaceutical costs, and we have TERRIBLE dental care for the elderly. WHY? Because half our healthcare dollar is siphoned off to buy private helipads for the homes of the shareholders of pharmaceutical companies.
We don’t have to argue about whether Medicare-for-all-type systems work better than ours does. All we have to do is to GO AND LOOK. The rest of the OECD has national healthcare systems. And they have better health outcomes. At half the cost.
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To make matters worse, private equity has been buying up hospitals, ERs and anesthesiology practices, ambulance companies, etc. Unless something is done for regular people, we are on our way to being the collateral damage of private equity profiteering. https://www.forbes.com/sites/robertpearl/2023/02/20/private-equity-and-the-monopolization-of-medical-care/?sh=56401102bad5
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Yes, these vultures are always first to where the bonanza profits lie.
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What a ridiculously corrupt and evil system! Tax payers fund the research and private corps own the patents and make obscene profits while people die and/or go into bankruptcy trying to get life saving drugs. Let’s hope that Biden is successful in his attempt to lower prescription drug prices.
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The yearly cost to Americans of Patent Protected Drugs over the cost of what they would sell for as Generics is 400 billion.
https://www.nytimes.com/roomfordebate/2015/09/23/should-the-government-impose-drug-price-controls/end-patent-monopolies-on-drugs
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Christmas Letter, 2024 | Bob Shepherd
Only a few are allotted to us. Perhaps you are young enough not to feel this yet, but you will. So, I figure I’d better write a Christmas letter while there is still time.
Yes, this is the time of the winter solstice, celebrated by pagans worldwide long, long, long before there was a Christ or a Christmas. And of course we have no idea on what day our brother Yeshua was born, but this day will do as well as any: a day to celebrate the rebirth of the Sun (when it starts traversing the sky ever higher until Midsummer), becomes a day to celebrate the Son. This is altogether fitting.
Leading up to this day, when I was a kid, Grandpa (or simply Pa, as we called him), would take me with him out to the woods to gather mistletoe and holly and cut a Christmas tree and drag it back (my brother was as yet too young for these excursions). Grandma (or Granny, as we called her) would put candles in the windows, and these seemed to me the purest, most beautiful things in the world, as did her tiny porcelain figurines of angels and Santa and his reindeer.
Let us pause to express our gratitude for the small and breathtaking beauties of our world, such as the light of a candle shining through a lattice of frost on a windowpane and stars literally twinkling through the ice crystals in the air.
There would always be lots of family at Christmas back then because Granny and Pa’s kids mostly built on parts of the farm, so it was easy enough to get them around a table. And on that table would be vegetables from Granny’s canning throughout the year, meat from their smokehouse, and peanut cake and lemonade. In that part of the country at that time, peanuts and lemons were easy enough to come by. So, she made do with what she had. This combination, btw, the sweetness of the cake and the acerbity of the lemonade, is astonishingly delicious. Country people (all those Grannies and Pas) know a thing or two.
And sometimes, for Christmas, way back then, I would get an orange. These were rare, and the smell and taste were exotic and exquisite. I wish I had a way of conveying how amazing such a thing is when one rarely has one. Imagine never having seen a tree and suddenly, boom, there one of these amazing things is!!!! This should remind us to see A LOT OF THINGS anew, in their true glory, each day, including ourselves and those around us. Let us remember this in this season of The Birth (and the rebirth).
I would be remiss if I didn’t remind you all that the First Noel was the certain good shepherds. LOL. But seriously, glad tidings to you. And on the shortest, darkest night of the year, feast and be merry and shine in the light of the love of friends and family.
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And peace to Israel and Palestine.
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“Let us pause to express our gratitude for the small and breathtaking beauties of our world, such as the light of a candle shining through a lattice of frost on a windowpane and stars literally twinkling through the ice crystals in the air.”
What a beautiful image!
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