News update re: Xtandi

[ragnar2020]

PROSTATE DRUG PETITION DENIED AGAIN — On Tuesday, the federal government rejected a petition asking the NIH to use so-called march-in rights to take ownership of patents tied to the pricey prostate cancer drug Xtandi, David reports.Such rights have yet to be used, but their aim is to help lower prices for drugs developed using government funds.HHS and the Department of Commerce will launch an interagency review of the government's authorities under the Bayh-Dole Act, which grants the march-in rights. The rejection, which affirms a similar 2016 determination, wasn’t well received by some Democrats on the Hill.“I am extremely disappointed that the Biden Administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi,” Sanders said in a statement following the announcement. “This is a drug that was invented with taxpayer dollars … and can be purchased in Canada for one-fifth the U.S. price.”That sentiment was shared by Rep. Lloyd Doggett (D-Texas), who said the “excessive price-gouging” cost taxpayers more than $2 billion in 2020.It’s also a blow to liberal groups, including Public Citizen and Families USA, which argue that taking such a step would rapidly lower the price of Pfizer and Astellas Pharma’s prostate cancer drug.“NIH’s analyses in response to the petition request have found Xtandi to be widely available to the public on the market,” wrote Lawrence Tabak, who is performing the duties of the NIH director. “In addition, given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”James Love, brother of one of the complainants and director of Knowledge Ecology International, a nongovernmental organization that focuses on intellectual property that has also petitioned NIH, lamented the decision, which he said has "no silver lining" and runs directly in contrast to the Biden administration’s executive order on drug prices.

[Magnus1964]

If big pharma is making billions on drugs, I would say they could afford to sell xtandi for a reasonable price. They just jacked up the price of Covid meds 400% which should soak billions more out of tax payer coffers.

[cujoe]

It all snowballed when the US allowed direct-to-consumer advertising. Last account, only New Zealand and US allow DTC advertising of prescription drugs. My understanding that most, if not all of the major drug companies now spend more money on advertising than they they do on drug development. And don't even get me started on the Rube Goldberg medical contrivance know as Medicare Part D!

And while I understand your interest in drug companies being able to continue to develop new drugs and test current ones, what we now have is a simple case of special interests owning the entire process and milking it for all the dollars they can get.

[Magnus1964 in reply to cujoe]

???

[cujoe in reply to Magnus1964]

And your question(s) would be?

[Magnus1964 in reply to cujoe]

I am having some difficulty with the forum mechanisms. The software is a little off. Or maybe the user.

[cujoe in reply to Magnus1964]

Welcome to the club (for either reason). Others have reported problems with HU's interface. Some attribute it to the browser in use and others to unknown conflicts. For three months or so I have been getting browser crashes (Firefox running on Win7pro) at random - often resulting in lost in-progress typing. Firefox is regularly updating, so that is unlikely the cause. These crashes ONLY occur when I am logged into HU and have a tab opened - never without? Anytime I do a long post, PM, or reply, I now use a text editor and copy/paste into HU. (It happened again last night when I was doing a short reply to smurtaw on this thread. Since I clear cookies whenever I close my browser, the crashes mean I have to again go through the HU login!)

[Magnus1964 in reply to cujoe]

One of the problems I have been having is to open 'Alerts' and when I click on a new "alert" I am taken to the top of the thread but not to the message that generated the alert.

You can by pass this (on a computer or laptop) by opening 'Alerts', then scroll to the bottom of the Alerts and click on "view all notifications". This opens a new page with all alerts listed. Clicking on an alert from this list will redirect you to the message.

Magnus

[cujoe in reply to Magnus1964]

That's an annoyance I've just learned to live with - as sometimes it seems to work and sometimes it doesn't. I know people who have tried to get HU to deal with all sorts of issues and I don't hear that they are very successful in getting solutions. Their PM tool is not even as sophisticated as most basic text editors. I guess Love it or Leave it is the only solution.

[cujoe]

My drug co rant was not directed at you personally. Free drugs is lie just like 'free' shipping; i.e., a non-existent entity. The questions most people who use (or need to use, but can't afford) pharma products are ones like: "Why are drugs more expensive here than anywhere else in the world?" and in view of that, "Why can Medicare not negotiate with suppliers outside the US to lower those costs?"

I'm on Medicare with a "place holder" Part D drug plan and will be using GoodRX for generics of bicalutamide, dutasteride, and tamoxifen. I was just quoted something over $290 for 3 mos of bical via my insurance at CVS, where GoodRX shows a price of about $28 at both Walmart and Publix. Hummm, which one will I have my script sent to? And how can there be that much markup for an off-patent 25+ year old drug in any case? BTW, Specialty drugs, like Enzalutamide are not available at GoodRX.

As far as I can tell, Cuban's Cost Plus deals exclusively with generics, so drugs still on patent will not be there. However, the current quote for generic Zytiga (abiraterone Acetate) is $36.60 (vs $1093.20 @ retail) Get real! An account is required and scripts have to be routed via CostPlus mailorder delivery system.

Even with their quarterly/annual membership fee, ScriptCo may be less expensive of all for drugs available there, so it does pay (less) to shop around even if you have insurance coverage.

Keep it Safe & Well - Ciao, K9 terror is ranting again . . .

[cujoe]

No, but I have a treatment review in several weeks and if I continue to use my current "old drug" regime into at least mid-year, I may give them a try. Their stated cost for 90 day scripts for bical+dutasteride+tamoxifen is $31.60 + $50 for quarterly membership for a total of $ 81.60 with free shipping. That works out to about $3 per individual 30-day script, which is about the same as tier 1 generics on most insurance plan formularies - sans deductibles, etc. They also offer a yearly individual membership for $140 and $280 for a family

The only problem I have heard of with mail order drugs via insurance plans is with delays in filling and shipping scripts. Not sure if that would be and issue with ScriptCo, but will do some digging over then next several weeks and let you know what I find. BTW, I only recently heard of ScriptCo via some post or reply several weeks back here or on another HU forum. For what it's worth, they have a 4.9 out of 5 review rating on Google. Info link:

scriptco.com/

Generics only and that may be a concern for some people.

Bedtime for K9s. Later, Ciao - Capt'n K9 now has the terror under control!

[Hidden]

There are no free rides in the world. To compare cost of pharmaceuticals to other countries fails to account for what one pays in taxes and fees for each country. A quick take away....

The U.S. has some of the lowest taxes in the world, both in terms of personal income tax rates and goods and services tax rates (sales taxes).

U.S. taxes represent about one-quarter of gross national product, compared to an average of 33% in other OECD countries.U.S. state and local sales taxes are much lower than VAT rates in Europe, which are typically at least 20%.

Income Tax

The United States' top individual tax rate is 37%. That's lower than the top rate in 17 out of 27 European countries.2 The countries with the highest tax rates were Denmark (56%) and Austria (55%).Outside of Europe, Israel (50%), Australia (45%), China (45%), and South Africa (45%) all have higher top rates than the U.S. Countries with lower top tax rates included Guatemala (7%), Norway (22%), Brazil (27.5%), and Canada (33%).

Consumption Tax (Sales Tax)

The U.S. taxes goods and services far less overall than any other OECD nation. In 2018, these types of taxes made up 18% of U.S. revenue compared to an average of 32% in all 38 OECD countries.Note: This Tax in the US determined by states. Outside the US, the tax is determined by country.

So in the end, how do you want to pay for your health care and other social type services? Essentially, a capitalistic view or a socialistic view? And maybe a combination view...... unstated is the amount that ones pays or doesn’t pay for insurance; understanding that the cost of coverage upfront dictates future benefits.

BTW, I watched and listened to witnesses who testified before the US Senate Subcommittee chaired by Senator Sanders yesterday on this very subject.

Gourd Dancer

[ragnar2020 in reply to Hidden]

Well said and considered. We would all like this to be much simpler and less complex, but reality is always a wake-up call.

[Magnus1964 in reply to Hidden]

And those other countries have universal health care, railroad that work, bridges without homeless people living under them..

[Hidden in reply to Magnus1964]

It’s a terrible situation that is growing worldwide. It is estimated the number of homeless people sleeping rough or in emergency/temporary accommodation in the European Union each night at 700,000, i.e. an increase of 70 % in ten years, from 2009 to 2019. I imagine that number has increased the past four years. Consider this: “The highest rates for lifetime literal homelessness were found in the UK (7.7%) and United States (6.2%), with the lowest rate in Germany (2.4%), and inter- mediate rates in Italy (4.0%) and Belgium (3.4%).”

GD

[Magnus1964]

It does not matter who pays for the vaccine, big pharma is getting rich off someone, you insurance, the government....

[Magnus1964]

Tax dollars pay for research. The drug company pay to refine the research, produce and test the drug and spend billions on lobbying and advertising.

[cujoe]

Strictly from a theoretical point of view, it would seem a SERM+SARM combo would be pretty effective for PCa. However, my research indicates that is not at all the case, either individually or in combo.

[cujoe]

BTW, Since recently starting Tamoxifen (for bical related gynecomastia), I have been digging into the ERa vs ERb issue with PCa. It seems most of the recent research throws into question much of the earlier research done with standard PCa cell types due to the isolated nature of such cells from the larger metabolic/genetic matrix. Seems the ERalpha=bad and ERbeta=good is not so clear cut as once thought.

[cujoe]

I took note of your earlier cautions on SARMs and the tiny dosages you actually use for QOL benefits. Your explicit details continue to be very useful to those of us following your evolving treatment program. Thanks for openly sharing,

[cujoe]

I keep thinking of all the clinical trials our government could be fully funding with the tax money we are sending to blow-up countries halfway around the world. That would mean the end-cost of proven meds would not be the $150+K per year that most new pharma drugs roll out at now. It's the "Broken Window Fallacy" replicated on a global scale. Same as it ever was . . .