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BIG PHARMA
PROFITABLE PRICING Medicare blocked Pharma price gouging. Now Big Pharma including Biogen is fighting back. 
Original article: https://www.statnews.com/2022/02/10/biogen-pushes-back-on-medicares-limits-on-alzheimers-drug-coverage-and-advances-a-counteroffer/ Burgess COMMENTARY The US pharmaceutical industry is a part of the dysfunction of the modern US socio-enviro-economic system. In purely technical terms is has done some impressive scientific work, but the cost, price and value of many of its products reflect an unhealthy imbalance between profit performance for the companies and social benefit for the consumers. There are many moving parts that enable scientific and medical progress, but the imbalance between cost to beneficiaries and the associated profits for the supplies seems to be sub-optimal, to say the least. I have been a corporate CFO and I have a good understanding about the behavior of costs over the life cycle of a product. It is not easy to find much useful information about these matters in the information available to the public, and most likely accessible to regulators. What was do know is that there is an expectation from the investor community that the return on investment for any and all drugs will be huge and always getting bigger. Most of the world's consumers have no idea how much the products that they consume have cost to produce, the amount of profit that is being made before the product reaches the consumer. Few consumers know which parts of the supply chain are doing the most to make the product profitable but expensive!!!!!!!!!!! In the case of pharmaceutical products, there is a role for government. Certain regulations are desirable in order to keep the products safe. Some patent protection is needed so that an innovator is able to earn back a reasonable return on their effort and investment. However, these rules and regulations and protections should not enable profit gouging as they seem to be doing at the present time and for the past many decades. Peter Burgess | ||
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Medicare blocked Pharma price gouging. Now Big Pharma is fighting back.
Alex Lawson, Social Security Works February 5th 2022, 12:27 PM Peter, What I’m about to ask you to do is difficult, but necessary―and it’s not asking for money. Please read this email all the way to the end. In 2022, Medicare premiums rose by over $20 per person, every month, due to a single drug. And here’s the worst part: The medicine, which purports to fight Alzheimer’s, was developed and approved through a corrupt process1. The medicine appears to be ineffective, but that hasn’t stopped Pharma giant Biogen from setting its price at $28,200! Because Medicare cannot by law negotiate lower prices, and this medicine is targeted directly for Medicare-aged individuals, widespread adoption of this drug could result in a direct transfer of Medicare’s entire trust fund right into Biogen’s bank account. Fortunately, the Centers for Medicare and Medicaid Services (CMS) came out with a draft rule last month that it would only cover Biogen’s medicine for certain clinical trials. This is a big win for Medicare premiums, and patient safety. But the fight isn’t over. CMS will issue its final ruling in April, and it’s accepting public comments until February 10th. Upon the announcement of the coverage limits, Biogen’s US president Alisha Alaimo pledged to flood CMS with comments in an attempt to stop last month’s decision.2 Unfortunately, CMS doesn’t make it easy for members of the public to make their voices heard, giving Big Pharma an inside track to rig the process! Most federal comment periods use a fairly straightforward system that makes sending a message as easy as signing a petition. But this particular comment period has a number of hurdles that make it difficult. Don’t worry―we’ve got your back. Here are step-by-step instructions on how to fight against Big Pharma greed! (click on any of the images below if you want to see them bigger) Click here and open the CMS Comment page in a new browser window or tab. On that page, click on the link that says “CMS PHI Posting Policy.” Once the policy popup opens, click “OK” to close it. Check the box below the CMS Posting Policy link. NOTE: You will not be able to fill in any of the forms until you’ve checked this box, and you can’t check this box until you’ve clicked “OK” in step 3 above. Fill out your first name, last name and email under “Identification” Copy this statement and paste it into the “Comment” box. Feel free to personalize it: The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients. Moreover, the integrity of the FDA’s review of the marketing application for Aduhelm was dangerously corrupted by the unprecedented and inappropriately close collaboration between Biogen and the FDA during the analyses of data from the key clinical trials of the drug after the termination of the phase 3 clinical trials because of futility. CMS must not compound the FDA’s egregious error in approving Aduhelm on June 7, 2021. Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug cannot possibly be deemed reasonable and necessary for treatment of such patients. I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. Fill out the required address fields, check the box to affirm that you are not a robot, and press “Submit!” Thanks for adding your voice on this important action, Alex Lawson ... Social Security Works
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