Latest Drugwonks' Blog
From today's Pittsburgh Tribune --
U.N.'s errant prescription for drug access
What's the best way to improve health care for billions of people in the developing world? If you answered, “Attack health care firms,” you qualify for a job with the United Nations.
You'd also be dead wrong.
The U.N. recently released a plan to severely weaken patent protections and other forms of intellectual property (IP). U.N. officials believe that this will bring down the price of medicine in the developing world, thereby improving people's access to drugs.
Their recommendations would do the exact opposite. Dissolving IP protections would disincentivize drug research and slow the discovery of new treatments. Patients in both the developing and developed worlds would be worse off.
Drug development is an enormously expensive endeavor. It costs, on average, $2.6 billion to bring a new medicine to market. Just one out of every 5,000 promising compounds makes it from the lab through clinical trials to the pharmacy shelf. And just two out of every 10 approved drugs ever turn a profit.
IP rights are what make risky drug research a worthwhile bet for investors. By temporarily preventing the production of generics and creating a market monopoly, they ensure that the original innovator has a chance to profit from successful new products.
America has the strongest IP protections in the world, and they've driven a spectacular rate of innovation.
We've created more than 500 new medications in the past 15 years alone. That's more than the rest of the world combined. And we account for 70 percent of the 7,000 new drugs now under development globally. We're also home to 12 of the top 20 medical-device companies in the world.
These research efforts are aimed at the most devastating diseases. Today, American scientists are working on 74 new asthma medicines, 92 new arthritis treatments, and 93 therapies for Alzheimer's disease. They're also developing over 800 cancer treatments.
These products lead to longer lives for people all over the world. Consider HIV/AIDS: Back in the 1980s, a diagnosis was a death sentence. Today, antiretroviral cocktails keep patients living for decades. There's no way firms would have plowed billions into researching and developing these therapies without strong patent protections.
Patent protections are not the reason poor patients in the developing world can't access breakthrough medications. Among the 375 drugs the World Health Organization has deemed essential, just 25 are still patented.
Cost isn't a problem either. Poor patients pay just 6 percent of the U.S. retail price for 350 off-patent drugs.
The U.N.'s war on IP rights ignores the real barrier to drug access: insufficient medical infrastructure.
For instance, many developing countries suffer from a severe shortage of health care professionals, particularly in rural areas. In Nicaragua, 50 percent of health personnel work in the country's capital, yet only 20 percent of the country's population lives there.
The U.N. needs to ditch its fixation on intellectual property rights and instead focus on the real problems of the developing world. Undermining IP protections would deter drug development and ultimately deprive needy patients of lifesaving treatments.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
U.N.'s errant prescription for drug access
What's the best way to improve health care for billions of people in the developing world? If you answered, “Attack health care firms,” you qualify for a job with the United Nations.
You'd also be dead wrong.
The U.N. recently released a plan to severely weaken patent protections and other forms of intellectual property (IP). U.N. officials believe that this will bring down the price of medicine in the developing world, thereby improving people's access to drugs.
Their recommendations would do the exact opposite. Dissolving IP protections would disincentivize drug research and slow the discovery of new treatments. Patients in both the developing and developed worlds would be worse off.
Drug development is an enormously expensive endeavor. It costs, on average, $2.6 billion to bring a new medicine to market. Just one out of every 5,000 promising compounds makes it from the lab through clinical trials to the pharmacy shelf. And just two out of every 10 approved drugs ever turn a profit.
IP rights are what make risky drug research a worthwhile bet for investors. By temporarily preventing the production of generics and creating a market monopoly, they ensure that the original innovator has a chance to profit from successful new products.
America has the strongest IP protections in the world, and they've driven a spectacular rate of innovation.
We've created more than 500 new medications in the past 15 years alone. That's more than the rest of the world combined. And we account for 70 percent of the 7,000 new drugs now under development globally. We're also home to 12 of the top 20 medical-device companies in the world.
These research efforts are aimed at the most devastating diseases. Today, American scientists are working on 74 new asthma medicines, 92 new arthritis treatments, and 93 therapies for Alzheimer's disease. They're also developing over 800 cancer treatments.
These products lead to longer lives for people all over the world. Consider HIV/AIDS: Back in the 1980s, a diagnosis was a death sentence. Today, antiretroviral cocktails keep patients living for decades. There's no way firms would have plowed billions into researching and developing these therapies without strong patent protections.
Patent protections are not the reason poor patients in the developing world can't access breakthrough medications. Among the 375 drugs the World Health Organization has deemed essential, just 25 are still patented.
Cost isn't a problem either. Poor patients pay just 6 percent of the U.S. retail price for 350 off-patent drugs.
The U.N.'s war on IP rights ignores the real barrier to drug access: insufficient medical infrastructure.
For instance, many developing countries suffer from a severe shortage of health care professionals, particularly in rural areas. In Nicaragua, 50 percent of health personnel work in the country's capital, yet only 20 percent of the country's population lives there.
The U.N. needs to ditch its fixation on intellectual property rights and instead focus on the real problems of the developing world. Undermining IP protections would deter drug development and ultimately deprive needy patients of lifesaving treatments.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
Today is Rare Disease Day. It should be an occasion for raising awareness about the fact that, despite progress in treating rare diseases, nearly 27 million people suffering from one of 7000 uncommon medical conditions do so with any effective treatment or cure.
Instead, the rare disease community finds itself under assault as little more than front groups for pharma companies who – critics claim – want the freedom to bankrupt our health care system by charge hundreds of thousands of dollars for medicines that aren’t that safe or effective.
The critics are attacking patient groups for strategic reasons: shut down patient groups or at least neutralize their influence and their organizations – anointed as objective and expert – will consolidate their power over the development, pricing and use of new medicines.
One of the leaders of this movement is Steven Pearson, the founder of the Institute for Clinical and Economic Review – an organization that claims it’s “a trusted non-profit organization that evaluates evidence on the value of medical tests, treatments, etc.” Pearson claims the influence of patient groups will drive our health care system and economy into bankruptcy. As the number drugs for rare diseases for small groups of patients increase, their higher prices (relative to medicines for common medical conditions) will become unaffordable. And the driving force is the ability of rare disease groups to advocate for new medicines.
Or as he puts in an article entitled, “Which Orphans Will Find a Home? The Rule of Rescue in Resource Allocation for Rare Diseases,” publicity can be a powerful and important tool for advocacy groups, “but it is not an appropriate ethical justification for coverage of particular orphan drugs over others.” Pearson writes, our nation needs a framework that will restrain “society’s desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals.”
Armed with this noble sentiment (and about $5 million from health insurers and the Laura and John Arnold Foundation) Pearson is positioning ICER to develop this ‘value framework.’
In May, ICER will be meeting with patient groups and others to recommend “fair prices that reflect the value of orphan drugs to patients and the health system to allow for broader insurance coverage for innovative new treatments.” (It is targeting Spinraza™ (a new drug for spinal muscular atrophy and Exondys-51™ for Duchenne muscular dystrophy (DMD))
Pearson believes that a “bright line between what constitutes a fair claim on health benefits and what does not will be difficult to draw.”
To ICER and Pearson, that bright line is $150000 for an additional year of life. Most new medicines for rare diseases are expensive and don’t save health insurers money. And ICER measures value from the insurer or government health program perspective. So most new orphan drugs would have been discounted more than 90 percent of the rebated price a medicine just to stay behind Pearson’s bright line.
Next, ICER sets a limit of $915 million on what should be spent on each new drug. It multiplies the price of the drug by the number of people who could benefit. Going over the cap mean that many people with rare diseases will be denied access to a growing array of new medicines. ICER uses these bright lines to “improve affordability” with changes to pricing, payment, or patient eligibility
ICER justifies such limits because beyond that cap it “…we’re siphoning off resources for other things we need like better schools and more resources for local police, roads, and bridges. “
These claims of budgetary Armageddon are overhyped. Between 2007 and 2014, orphan drugs have increased as a percentage of spending on drugs (from about 2 percent to 4 percent in Europe and 5 percent to 8 percent in the United States) even as the percentage spent on drugs has remained the same. And a study by Dr. Frank Lichtenberg shows new medicines for rare diseases are reducing the number of life years lost by about five percent a year.
Conversely, ICER’s limits on access will hurt people and rob them of their lives. Lichtenberg’s study found in France, which took longer to pay for fewer orphan drugs relative to the US, the number of deaths declined by 1.8 percent.
It is precisely our moral sense to save lives in immediate danger and at any expense that sustains humanity and economic progress. We need more orphan drugs not just because more people will be able to enjoy life and live longer. It’s because civilization is enriched when we provide people who are marginalized because of their medical condition the opportunity to contribute to our well-being and happiness.
Pearson and ICER are a threat to that moral vision. They threaten the remarkable advances in medicine that Rare Disease Day celebrates, made possible in large part by the patient advocacy groups that ICER seeks to replace.
Instead, the rare disease community finds itself under assault as little more than front groups for pharma companies who – critics claim – want the freedom to bankrupt our health care system by charge hundreds of thousands of dollars for medicines that aren’t that safe or effective.
The critics are attacking patient groups for strategic reasons: shut down patient groups or at least neutralize their influence and their organizations – anointed as objective and expert – will consolidate their power over the development, pricing and use of new medicines.
One of the leaders of this movement is Steven Pearson, the founder of the Institute for Clinical and Economic Review – an organization that claims it’s “a trusted non-profit organization that evaluates evidence on the value of medical tests, treatments, etc.” Pearson claims the influence of patient groups will drive our health care system and economy into bankruptcy. As the number drugs for rare diseases for small groups of patients increase, their higher prices (relative to medicines for common medical conditions) will become unaffordable. And the driving force is the ability of rare disease groups to advocate for new medicines.
Or as he puts in an article entitled, “Which Orphans Will Find a Home? The Rule of Rescue in Resource Allocation for Rare Diseases,” publicity can be a powerful and important tool for advocacy groups, “but it is not an appropriate ethical justification for coverage of particular orphan drugs over others.” Pearson writes, our nation needs a framework that will restrain “society’s desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals.”
Armed with this noble sentiment (and about $5 million from health insurers and the Laura and John Arnold Foundation) Pearson is positioning ICER to develop this ‘value framework.’
In May, ICER will be meeting with patient groups and others to recommend “fair prices that reflect the value of orphan drugs to patients and the health system to allow for broader insurance coverage for innovative new treatments.” (It is targeting Spinraza™ (a new drug for spinal muscular atrophy and Exondys-51™ for Duchenne muscular dystrophy (DMD))
Pearson believes that a “bright line between what constitutes a fair claim on health benefits and what does not will be difficult to draw.”
To ICER and Pearson, that bright line is $150000 for an additional year of life. Most new medicines for rare diseases are expensive and don’t save health insurers money. And ICER measures value from the insurer or government health program perspective. So most new orphan drugs would have been discounted more than 90 percent of the rebated price a medicine just to stay behind Pearson’s bright line.
Next, ICER sets a limit of $915 million on what should be spent on each new drug. It multiplies the price of the drug by the number of people who could benefit. Going over the cap mean that many people with rare diseases will be denied access to a growing array of new medicines. ICER uses these bright lines to “improve affordability” with changes to pricing, payment, or patient eligibility
ICER justifies such limits because beyond that cap it “…we’re siphoning off resources for other things we need like better schools and more resources for local police, roads, and bridges. “
These claims of budgetary Armageddon are overhyped. Between 2007 and 2014, orphan drugs have increased as a percentage of spending on drugs (from about 2 percent to 4 percent in Europe and 5 percent to 8 percent in the United States) even as the percentage spent on drugs has remained the same. And a study by Dr. Frank Lichtenberg shows new medicines for rare diseases are reducing the number of life years lost by about five percent a year.
Conversely, ICER’s limits on access will hurt people and rob them of their lives. Lichtenberg’s study found in France, which took longer to pay for fewer orphan drugs relative to the US, the number of deaths declined by 1.8 percent.
It is precisely our moral sense to save lives in immediate danger and at any expense that sustains humanity and economic progress. We need more orphan drugs not just because more people will be able to enjoy life and live longer. It’s because civilization is enriched when we provide people who are marginalized because of their medical condition the opportunity to contribute to our well-being and happiness.
Pearson and ICER are a threat to that moral vision. They threaten the remarkable advances in medicine that Rare Disease Day celebrates, made possible in large part by the patient advocacy groups that ICER seeks to replace.
WSJ reporters Jonathan Rockoff and Peter Loftus suggest how PBMs and health plans pocket rebates while charging patients list price even as pharma limits price increases ("Facing Criticism, Drug Makers Keep Lid On Price Increases" 2/16/2017) At the same time, the American Cancer Society Cancer Action Network warns that under the ACA “most plans place many, or even all, covered cancer drugs on the highest cost-sharing tier.”
Specifically, Rockoff and Loftus report: most of the increases in list prices are not paid by insurers. PBMs and insurers have their drug costs reduced by rebates and discounts, while consumers (patients) pay the full price. Here's the chart that demonstrates this fact.
Source IMS Health
In addition to pocketing rebates, PBMs and insurers make money by charging consumers of the newest drugs up to 50 percent of the list – not rebated price of the drug. Indeed, Rockoff and Loftus try to skate past this ripoff by blandly noting: "regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year. Indeed, patients who have high deductible plans are not paying anywhere near full price for any other medical service except prescription drugs.
The article notes: "The discounts mean that manufacturers must share the increased revenue with others, but they can still leave buyers such as insurers paying the higher price, or most of it. And regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year."
As if on cue the American Cancer Society Cancer Action Network released its most recent review of drug cost sharing for cancer patients on Obamacare plans and concluded:
"Unfortunately, most plans place many, or even all, covered cancer drugs on the highest cost-sharing tier. Among the formularies we studied, even generic cancer drugs appeared on the most expensive tier with regularity (41 percent of the time in the case of Etopside, and 61 percent for Imatinib Mesylate). Most of the time, the highest cost-sharing tier requires coinsurance rather than a flat copayment; but it is very difficult for consumers to manually estimate their coinsurance costs because the negotiated drug price on which coinsurance is based is not shown.”
So if drug companies are keeping the lid on drug prices, why aren't cancer patients seeing any difference at the pharmacy?
Specifically, Rockoff and Loftus report: most of the increases in list prices are not paid by insurers. PBMs and insurers have their drug costs reduced by rebates and discounts, while consumers (patients) pay the full price. Here's the chart that demonstrates this fact.
Source IMS Health
In addition to pocketing rebates, PBMs and insurers make money by charging consumers of the newest drugs up to 50 percent of the list – not rebated price of the drug. Indeed, Rockoff and Loftus try to skate past this ripoff by blandly noting: "regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year. Indeed, patients who have high deductible plans are not paying anywhere near full price for any other medical service except prescription drugs.
The article notes: "The discounts mean that manufacturers must share the increased revenue with others, but they can still leave buyers such as insurers paying the higher price, or most of it. And regardless of discounts to middlemen, patients who have high-deductible health plans may have to pay close to full price for at least part of the year."
As if on cue the American Cancer Society Cancer Action Network released its most recent review of drug cost sharing for cancer patients on Obamacare plans and concluded:
"Unfortunately, most plans place many, or even all, covered cancer drugs on the highest cost-sharing tier. Among the formularies we studied, even generic cancer drugs appeared on the most expensive tier with regularity (41 percent of the time in the case of Etopside, and 61 percent for Imatinib Mesylate). Most of the time, the highest cost-sharing tier requires coinsurance rather than a flat copayment; but it is very difficult for consumers to manually estimate their coinsurance costs because the negotiated drug price on which coinsurance is based is not shown.”
So if drug companies are keeping the lid on drug prices, why aren't cancer patients seeing any difference at the pharmacy?
An interesting post at OhMD discusses a new study showing that “96% of patients report leaving their doctor’s office with limited knowledge of how to use the patient portal. Of the 40% of patients who said they had attempted to use the patient portal in 2016, 83% said it was too complicated to use.” That means only 7% of patients find it simple enough to use, and actually care to use it.
As the folks at OhMD quip, “As a point of reference, 7% of the American population also believes the moon landing was faked, if that helps give you some perspective.”
Why? Consumer technology (the apps we all use in our daily lives) typically solve a problem in a very simple way.
As I’ve said before – healthcare app-ens.
As the folks at OhMD quip, “As a point of reference, 7% of the American population also believes the moon landing was faked, if that helps give you some perspective.”
Why? Consumer technology (the apps we all use in our daily lives) typically solve a problem in a very simple way.
As I’ve said before – healthcare app-ens.
ProPublica, although calling itself "journalism in the public interest,” remains silent about its own funding and conflicts of interest while it brazenly challenges others.
A recent article, " Big Pharma Quietly Enlists Leading Professors to Justify $1,000-a-Day Drugs," questions the credibility of respected academic experts who explain and defend the high cost of developing new treatments and cures, simply because they get funding from the pharmaceutical industry.
Yet, ProPublica receives funding from Arnold Foundation, dedicated to attacking drug pricing, drug spending and by extension the pharmaceutical industry.
Since 2013 ProPublica has received $4 million from the Arnold Foundation. The support is part of nearly $20 million in multiyear grants to organizations that are being paid by the foundation to develop new policies to attack drug prices in a way that will reduce the development of new treatments and cures.
In addition, the foundation is funding news outlets like ProPublica to report on the organizations it is funding, and to support a group called Patients for Affordable Drugs who advocate for policies the other Arnold entities are creating and publicizing. So ProPublica is part of what the foundation calls a 'portfolio of investments' in attacking drug pricing and drug spending. That's journalism in ProPublica's financial interest, not in the public interest.
The piece claims that the scholars (who have a firm called Precision Health Economics of PHE) enlisted by drug companies to defend prices didn’t regularly disclose funding, In fact, the economists who such as Tom Philipson, Dana Goldman and Darius Lakdawalla have been conducting such research for nearly 20 years and they have been disclosing their funding when required or relevant. In any event their relationship with companies was well known to everyone in the field.
Ironically, ProPublica alleges monkey business because of PHE’s failure to disclose in an article But Propublica has also has conflicts which,unlike PSE, it doesn’t disclose at all.
That’s not just being “quietly enlisted: That’s keeping quiet to avoid being criticized for hypocrisy.
Indeed, Annie Waldman, the author of the article, interviewed several individuals and discusses alternative value frameworks who disagree with the PHE methodology and belittle their assertions about prices reflecting values.
These sources are funded by the Arnold Foundation as well.
To discredit the claim that new drugs cost a lot to develop Waldman cites Dr. Aaron Kesselheim who states: “There is substantial evidence that the sources of transformative drug innovation arise from publicly funded research in government and academic labs.” Kesselheim is “an associate professor at Harvard Medical School whose research looks at the cost of pharmaceuticals. Pharmaceutical pricing, he says, is primarily based on what the market can bear.”
And Kesselheim also gets funding from the Arnold Foundation.
Waldman also discusses the role of ICER in setting drug prices based upon its opinion of value. She describes ICER as an organization vigorously attacking US drug prices. Waldman states that: “Some patient groups have contended that ICER emphasizes cost savings because it receives funding from health insurers. However, foundations are ICER’s biggest source of funding, and it is also supported by the pharmaceutical industry and government grants. “
ICER does NOT get money from the drug industry. Waldman fails to mention funding from California Blue Cross Blue Shield Foundation or that ICER receives most of its funding -- $4.6 million from the unmentioned Arnold Foundation.
It is perfectly acceptable to criticize PHE approach on substance. But as a colleague of mine observed: “foundation money is no different than pharma money if the purpose is the same: to support advocacy-driven research.” I applaud the Arnold Foundation for supporting groups that advance its drug pricing agenda and I am grateful to receive funding to advance other ideas about how to make medical innovation accessible and affordable.
However, if you are going to make funding sources an issue, it should apply to thee and me. And more to the point, if you are a media outlet receiving money from an organization that also funds the groups you cite in your article and use to research your piece, you should at least tell the public that. That’s not just nondisclosure. That’s misleading. It certainly isn’t journalism.
Jayne O' Donnell believes that patient groups that get money from biotech and pharma are corrupt. Her USA Today article: "New patient group focuses on drug prices amid bipartisan concern" starts off with this guilt by association meme:
"A new patient advocacy group launches Wednesday that distinguishes itself by focusing only on drug prices and eschewing money from the pharmaceutical industry at a time when drug makers are pouring millions into a campaign fighting efforts to regulate them."
In otherwords, groups that get money from biopharma companies are not legitimate. O' Donnell claims the new group -- Patients For Affordable Drugs -- is the only organization tackling policies to bring down drug prices because they are pharma free. That is untrue. What is true is that most patients groups -- and not PAFD focusing on the rigged system wherein PBMs, insurers and government health programs that set drug prices to maximize rebate revenue. Those are the prices that matter. If you want to reduce launch prices and price increases of drug companies, change the way drugs are paid for and the cost of drug development. PFAD ignores both. Why?
They focus on the immoral practice of getting $100 billion in rebates (that reduce drug prices) and then forcing the sickest patients to pay up to 50 percent of the retail price of the same drugs. (That's another $30 billion from less than 3 percent of all patients) But PFAD is perfect because it doesn't take 'drug' money. So what if it ignores the rebate games, the forced drug switching, fail first step therapy, etc. So what if it ignores the fact that by passing through rebate dollars the patient share of any drug cost could be zero, without raising premiums.
PFAD is perfect because it doesn't get drug money and supports government negotiated drug pricing for Medicare without acknowledging that such practices have hurt patients in Medicaid, the VA and everywhere price controls are used around the world.
Guess what other organizations share the same approach or seek to promote it? ICER, the drug pricing group at the Oregon Health & Science University, and several others. And they all get money from the John and Laura Arnold Foundation which has publicly stated it wants to build a network of groups attacking drug prices and the 'grass roots' entities to lobby for the policies and approaches the other entities produce.
So the real debate is how to best increase the pace of medical innovation and ensure that they are accessible. The Arnold-funded family of groups pursue administrative approaches and regulations to limit price and the pace of drug development. No mention of PBMs, insurers, etc. Patient groups are focusing on the system as a whole. And patient groups are less likely to support more government control over prices and access. They want a patient-centered drug development process. Arnold-funded 'experts' want more randomized trials where patients are exposed to placebos half the time.
To assert that Arnold foundation money is less tainted than money from a biotech company is ridiculous. If patient groups got money from the Merck Foundation instead of Merck for instance, would it pass O'Donnell's purity test?
(Many companies fought against eugenics in the early part of the 20th century. Foundations supported eugenics, accusing corporations of simply wanting more immigrants to work in their factories. )
It is time to stop branding patient groups as tainted because of their funding sources. Let's focus on the issues. The Arnold Foundation is seeking to change policy. So are patient groups.
"A new patient advocacy group launches Wednesday that distinguishes itself by focusing only on drug prices and eschewing money from the pharmaceutical industry at a time when drug makers are pouring millions into a campaign fighting efforts to regulate them."
In otherwords, groups that get money from biopharma companies are not legitimate. O' Donnell claims the new group -- Patients For Affordable Drugs -- is the only organization tackling policies to bring down drug prices because they are pharma free. That is untrue. What is true is that most patients groups -- and not PAFD focusing on the rigged system wherein PBMs, insurers and government health programs that set drug prices to maximize rebate revenue. Those are the prices that matter. If you want to reduce launch prices and price increases of drug companies, change the way drugs are paid for and the cost of drug development. PFAD ignores both. Why?
They focus on the immoral practice of getting $100 billion in rebates (that reduce drug prices) and then forcing the sickest patients to pay up to 50 percent of the retail price of the same drugs. (That's another $30 billion from less than 3 percent of all patients) But PFAD is perfect because it doesn't take 'drug' money. So what if it ignores the rebate games, the forced drug switching, fail first step therapy, etc. So what if it ignores the fact that by passing through rebate dollars the patient share of any drug cost could be zero, without raising premiums.
PFAD is perfect because it doesn't get drug money and supports government negotiated drug pricing for Medicare without acknowledging that such practices have hurt patients in Medicaid, the VA and everywhere price controls are used around the world.
Guess what other organizations share the same approach or seek to promote it? ICER, the drug pricing group at the Oregon Health & Science University, and several others. And they all get money from the John and Laura Arnold Foundation which has publicly stated it wants to build a network of groups attacking drug prices and the 'grass roots' entities to lobby for the policies and approaches the other entities produce.
So the real debate is how to best increase the pace of medical innovation and ensure that they are accessible. The Arnold-funded family of groups pursue administrative approaches and regulations to limit price and the pace of drug development. No mention of PBMs, insurers, etc. Patient groups are focusing on the system as a whole. And patient groups are less likely to support more government control over prices and access. They want a patient-centered drug development process. Arnold-funded 'experts' want more randomized trials where patients are exposed to placebos half the time.
To assert that Arnold foundation money is less tainted than money from a biotech company is ridiculous. If patient groups got money from the Merck Foundation instead of Merck for instance, would it pass O'Donnell's purity test?
(Many companies fought against eugenics in the early part of the 20th century. Foundations supported eugenics, accusing corporations of simply wanting more immigrants to work in their factories. )
It is time to stop branding patient groups as tainted because of their funding sources. Let's focus on the issues. The Arnold Foundation is seeking to change policy. So are patient groups.
The best way to reduce opioid abuse is to reduce the number of opioid tablets being dispensed. That means we need smarter physician prescribing habits. According to the results of a Columbia University Medical Center (published in American Journal of Psychiatry), “people with moderate or more severe pain had a 41 percent higher risk of developing prescription opioid use disorders than those without, independent of other demographic and clinical factors.”
In other words, it’s not just fewer opioids for patients with less severe pain or with conditions for which there are non-opioid alternatives (such as fibromyalgia and diabetic neuropathy). It means we need better ways of tracking the patient experience. One solution to narrowing the gap between prescription and outcomes measurement are mobile apps. The gathering and appraisal of real world evidence can expedite identification of problems before they become deadly. If we can identify misuse earlier, we can help eradicate abuse and addiction.
Apps present us with just that opportunity – a virtual ounce of prevention.
In other words, it’s not just fewer opioids for patients with less severe pain or with conditions for which there are non-opioid alternatives (such as fibromyalgia and diabetic neuropathy). It means we need better ways of tracking the patient experience. One solution to narrowing the gap between prescription and outcomes measurement are mobile apps. The gathering and appraisal of real world evidence can expedite identification of problems before they become deadly. If we can identify misuse earlier, we can help eradicate abuse and addiction.
Apps present us with just that opportunity – a virtual ounce of prevention.
ICER CEO Steve Pearson has tried to salvage what's left of the organization's shredded credibility by claiming ICER's mission is to help patients. Specifically, ICER argues that it all it wants to do is "spur discussion among stakeholders to ensure that patients have access to the medications at prices that are aligned with the value they bring to patients.”
In fact, ICER was established to evaluate whether the price of drugs reflected value from the perspective of PBMs and health insurers. As ICER notes, it uses a "US health system perspective (i.e., focus on direct medical care costs)."
So when Pearson told MS patients today at an ICER meeting that the institute cannot quantify the benefits of new drugs to MS, it was just another evasion. In fact, ICER excludes the patient perspective because its mission to maximize the benefits to insurers and PBMs. Indeed, if spending exceeds that cap and therefore hurts the health system, ICER recommends changes in which MS patients would get medicines and how many would benefit. Of course none of these components of the ICER analysis were discussed. The same goes for the impact of limiting spending on each new drug to $915 million. The goal is to hide ICER's real face, which it shows to a fawning media and its PBM and insurer constituency.
Similarly, every time discussion turned to step therapy, how patients pay a share of the list price of a drug even as PBMs and insurers grab more rebates through price increases, Pearson steered the conversation in a different and self-serving direction. Instead, Pearson reminded everyone how drug prices rose and asserted that if MS drug prices had remained the same, then all of the medicines would be cost-effective.
Let's deal with this claim before turning to how ICERs value framework affects MS patients
To be sure, since 2011 the list price for Copaxone, Betaseron, Avonex, and Rebif have risen substantially to keep pace with the launch price of newer MS drugs in an apparent effort to maximize revenue as these injectable products lost market share. It also turns out that since 2011, rebates and discounts (which go to PBMs and insurers) were 60 percent of the price increase of these older products.
Further, since 2011 the primary driver in MS drug spending was the introduction of new medicines and greater use of oral MS medications. As the IMS study of drugs use notes: "Oral medicines now account for half of new treatment starts in 2015, steadily increasing since the introduction of these new treatment options six years ago and up from 26% in 2011."
But here too, rebates and discounts whittled down the actual increase in spending by about 30 percent according to my estimates based on Credit Suisse rebate data.
Further, even though ICER now attempts to calculate drug prices net of rebates, it is silent about the fact that these savings are pocketed by PBMs and insurers. (Indeed, Pearson is afraid to raise the issue.) And ICER is quiet about the fact even as payors rake in cash rebates that reduce the cost of medicines; they continue to charge patients up to 50 percent of the list price of medicines.
And price increases don't change the fact that If ICER had been in place 15 years ago, not one of the medicines used today would be considered cost effective at $150K per QALY
Between 2000-2015 the combined deficit in life years lost (those that would not be saved and the additional years lost) would have been 59000 with a loss of $17 billion in value.
Similarly, ICER claims not one MS drug developed since 2015 is cost effective. I estimate that between 2017-2022 limited use of these medicines would cost patients 11300 life years and $3.9 billion a year.
ICER’s public relations campaign to portray itself as the voice of the patient is deadly deception. It cannot be trusted to protect patients or fully include the value of new medicines to the people who are most in need of medical innovation.
In short, ICER’s policy prescriptions will cripple MS patients.
President Trump will ask prominent vaccine safety skeptic Robert F. Kennedy Jr. to lead a planned commission to study vaccine safety, Kennedy said Wednesday. Commission members will include "household names" who "have not taken a position on the issue" of vaccine safety, he said.
Hm.
Kennedy said that in a Jan. 10 meeting, Trump told him he expected an "uproar" from the pharmaceutical industry concerning vaccines, and that the industry "would try to make him back down and he wouldn’t back down.” Immediately after the meeting, Kennedy told reporters that Trump had asked him to lead a vaccine safety commission, a claim Trump staff quickly denied. At a press conference Wednesday, Kennedy said he has since spoken with Trump staffers twice.
"They say they are still going forward with” a commission, he said. Kennedy spent much of the press conference repeating widely discredited theories about links between thimerosal in vaccines and neurological disorders in children. In fact, almost no pediatric vaccines contain the preservative, according to an FDA document.
Kennedy also vilified the CDC as a “cesspool of corruption,” and accused FDA, the drug industry, and the scientific and medical establishment of colluding to poison American children.
Actor Robert De Niro, who was also in attendance, said he "agreed 100%" with Kennedy’s comments. Kennedy and De Niro said they are not "anti-vaxxers," but they remained silent when Tony Muhammad, a representative of the Nation of Islam, told reporters that polio vaccines had caused 95 million cases of cancer in America.
Considering Mr. De Niro’s macho man video aimed at the President during the election, he’s come a long way – except that he hasn’t.
Shame. Shame. Shame.
How about a Presidential commission on how to educate the American public (and particularly the parents of young children) on the safety and urgency of vaccinations?
Via Forbes …
The Privacy Delusions Of Genetic Testing
BY: Peter Pitts
Mr. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
Genetic testing promises a revolution in healthcare. With just a few swabs of saliva, diagnostics can provide an unprecedented look into a person’s family history and potential health risks. Within a decade, global sales of genetic tests are expected to hit $10 billion. Direct-to-consumer companies such as 23andMe and Genos have proven particularly popular, with tens of thousands of people purchasing at-home testing kits every year.
But the industry’s rapid growth rests on a dangerous delusion: that genetic data is kept private. Most people assume this sensitive information simply sits in a secure database, protected from hacks and misuse.
Far from it. Genetic-testing companies cannot guarantee privacy. And many are actively selling user data to outside parties.
The problem starts with the Health Insurance Portability and Accountability Act (HIPAA), a 1996 federal law that allows medical companies to share and sell patient data if it has been “anonymized,” or scrubbed of any obvious identifying characteristics.
In 2013, 23andMe CEO Anne Wojcicki speaks at an announcement for the Breakthrough Prize in Life Sciences on UCSF’s Mission Bay. In 2015 the Google-backed genetic testing company pledged to reintroduce some health-screening tools that regulators had forced off the market, due to concerns about accuracy and interpretation.
The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine. But today, that loophole has proven to be a cash cow. For instance, 23andMe has sold access to its database to at least 13 outside pharmaceutical firms. One buyer, Genentech, ponied up a cool $10 million for the genetic profiles of people suffering from Parkinson’s. AncestryDNA, another popular personal genetics company, recently announced a lucrative data-sharing partnership with the biotech company Calico.
Customers are wrong to think their information is safely locked away. It’s not; it’s getting sold far and wide. Many testing firms that generally don’t sell patient information, such as Ambry and Invitae, give it away to public databases. Such transfers, as privacy consultant Bob Gellman puts it, leave a “big gap in protections.” Hacks are inevitable. Easily accessible, public genetic depositories are obvious targets.
If genetic data does fall into the hands of nefarious actors, it’s relatively easy for them to de-anonymize it. New lab techniques can unearth genetic markers tied to specific, physical traits, such as eye or hair color. Sleuths can then cross-reference those traits against publicly available demographic data to identify the donors.
Using this process, one MIT scientist was able to identify the people behind five supposedly anonymous genetic samples randomly selected from a public research database. It took him less than a day. Likewise, a Harvard Medical School professor dug up the identities of over 80% of the samples housed in his school’s genetic database. Privacy protections can be broken. Indeed, no less than Linda Avey, a cofounder of 23andMe, has explicitly admitted that “it’s a fallacy to think that genomic data can be fully anonymized.”
Once genetic data has been linked to a specific person, the potential for abuse is vast and frightening. Imagine a political campaign exposing a rival’s elevated risk of Alzheimer’s. Or an employer refusing to hire someone because autism runs in her family. Imagine a world where people can have their biology held against them. Such abuses represent a profound violation of privacy. That’s the risk inherent in current genetic-testing practices.
For their part, direct-to-consumer testing companies have been less than forthright about these dangers, usually burying privacy disclaimers deep in their contracts and refusing to disclose how long they keep customer data or how it can be used.
23andMe customers have to wade through pages of fine print before finding out that their information may be “shared with research partners, including commercial partners.” AncestryDNA’s contract claims a “perpetual, royalty-free, worldwide, transferable license to use your DNA.” New research published in the journal Nature found that genetic-testing companies frequently fail to meet even basic international transparency standards.
Genetic testing has tremendous benefits. We are provided a closer look at our own biology. Medical researchers develop a deeper understanding of the origins of disease and can create powerful new treatments. But today, far too many donors are operating under a false sense of security, handling profoundly intimate data without appropriate protections.
The Privacy Delusions Of Genetic Testing
BY: Peter Pitts
Mr. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
Genetic testing promises a revolution in healthcare. With just a few swabs of saliva, diagnostics can provide an unprecedented look into a person’s family history and potential health risks. Within a decade, global sales of genetic tests are expected to hit $10 billion. Direct-to-consumer companies such as 23andMe and Genos have proven particularly popular, with tens of thousands of people purchasing at-home testing kits every year.
But the industry’s rapid growth rests on a dangerous delusion: that genetic data is kept private. Most people assume this sensitive information simply sits in a secure database, protected from hacks and misuse.
Far from it. Genetic-testing companies cannot guarantee privacy. And many are actively selling user data to outside parties.
The problem starts with the Health Insurance Portability and Accountability Act (HIPAA), a 1996 federal law that allows medical companies to share and sell patient data if it has been “anonymized,” or scrubbed of any obvious identifying characteristics.
In 2013, 23andMe CEO Anne Wojcicki speaks at an announcement for the Breakthrough Prize in Life Sciences on UCSF’s Mission Bay. In 2015 the Google-backed genetic testing company pledged to reintroduce some health-screening tools that regulators had forced off the market, due to concerns about accuracy and interpretation.
The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine. But today, that loophole has proven to be a cash cow. For instance, 23andMe has sold access to its database to at least 13 outside pharmaceutical firms. One buyer, Genentech, ponied up a cool $10 million for the genetic profiles of people suffering from Parkinson’s. AncestryDNA, another popular personal genetics company, recently announced a lucrative data-sharing partnership with the biotech company Calico.
Customers are wrong to think their information is safely locked away. It’s not; it’s getting sold far and wide. Many testing firms that generally don’t sell patient information, such as Ambry and Invitae, give it away to public databases. Such transfers, as privacy consultant Bob Gellman puts it, leave a “big gap in protections.” Hacks are inevitable. Easily accessible, public genetic depositories are obvious targets.
If genetic data does fall into the hands of nefarious actors, it’s relatively easy for them to de-anonymize it. New lab techniques can unearth genetic markers tied to specific, physical traits, such as eye or hair color. Sleuths can then cross-reference those traits against publicly available demographic data to identify the donors.
Using this process, one MIT scientist was able to identify the people behind five supposedly anonymous genetic samples randomly selected from a public research database. It took him less than a day. Likewise, a Harvard Medical School professor dug up the identities of over 80% of the samples housed in his school’s genetic database. Privacy protections can be broken. Indeed, no less than Linda Avey, a cofounder of 23andMe, has explicitly admitted that “it’s a fallacy to think that genomic data can be fully anonymized.”
Once genetic data has been linked to a specific person, the potential for abuse is vast and frightening. Imagine a political campaign exposing a rival’s elevated risk of Alzheimer’s. Or an employer refusing to hire someone because autism runs in her family. Imagine a world where people can have their biology held against them. Such abuses represent a profound violation of privacy. That’s the risk inherent in current genetic-testing practices.
For their part, direct-to-consumer testing companies have been less than forthright about these dangers, usually burying privacy disclaimers deep in their contracts and refusing to disclose how long they keep customer data or how it can be used.
23andMe customers have to wade through pages of fine print before finding out that their information may be “shared with research partners, including commercial partners.” AncestryDNA’s contract claims a “perpetual, royalty-free, worldwide, transferable license to use your DNA.” New research published in the journal Nature found that genetic-testing companies frequently fail to meet even basic international transparency standards.
Genetic testing has tremendous benefits. We are provided a closer look at our own biology. Medical researchers develop a deeper understanding of the origins of disease and can create powerful new treatments. But today, far too many donors are operating under a false sense of security, handling profoundly intimate data without appropriate protections.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
