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Archive for the ‘Access to Medicines’ Category

Old US Public Health Service Hospital (known as Pacific Tower during its tenure as Amazon HQ building) to become new satellite campus for allied health professions programs of Seattle Central Community College and serve as site for public agencies and NGOs. AmazonBeaconHillHQ*304

Seattleite Jeanne Sather, author of Assertive Cancer patient  blog ,died from metastatic breast cancer  15 years after her original diagnosis

In June the King County Board of Health unanimously approved creation of drug take-back system for county residents , to be financed by a 2-cent per Rx tax. On Dec. 1, PhRMA filed a lawsuit against King County , claiming that the plan causes a financial burden for patients and that in-home disposal of  medicines is the best way to keep Rx drugs out of the wrong hands.

State to review hospital affiliations — Catholic and otherwise

Public hospital CEO gets pay cut to $1 M per year, at Renton’s Valley Medical Center

Harborview to close  pediatrics, women’s, & family clinics

Health Care Reform for American Indians and Alaska Natives 2013  including WA-specific page

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Those who have been following the saga of the leukemia wonder drug imatinib mesylate or Glivec (spelled Gleevec in North America to standardize pronunciation) may recall that it was said to be the first medicine for which a global price was set. At the time of its 2001 FDA approval, the worldwide price was US$2400/month, for  a base dosage of  a 30 day supply of 400mg caps.  Indeed, Novartis CEO  Daniel Vasella went to great lengths to discuss and justify both the high price and the pricing decision in his subsequent infomercial-type book  Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical HistoryThe Gleevec story is notable too in that the typical pharma claim that the price is justified by R & D costs, was refuted by researcher Brian Druker MD, who detailed how most of the initial work on imatinib was publicly funded and he had to convince Novartis to  produce enough of it to begin clinical trials with CML patients. Dr. Druker has also gone on record to criticize  the price being charged for Glivec.

Since then patients in wealthy countries mostly have been clamoring for their  public or private insurance to cover  the drug (and its second-line successors) not that something be done about the price that is exorbitant even in their economies. Novartis  invested heavily in worldwide patient relationship marketing for Glivec , which has contributed to this phenomenon, a topic  explored previously in this blog. In recent years,  it has become much more common to hear complaints from US patients and even some of the big-box disease associations, about the escalating price of  drugs like Glivec and  especially for new biologics. But it has  been rare to to hear demands that something be done about drug prices.

So the recent posting of a patient petition on change.org calling for action to reduce the price of Gleevec is notable:  Novartis and US Representatives in Congress: Reduce to patients the cost of the drug, Gleevec.

The introduction of the petition reads:

Novartis developed this drug in the 1990s. In the years since then the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost

Setting aside the issue of  misunderstanding that there are no price controls on prescription drugs in the US open market and that the FDA does not regulate drug prices, the petition is significant as a reflection of the increasing desperation of middle-class privately insured patients. They are among the majority here whose insurance status and/or income levels typically disqualify them for the patient assistance programs much touted by Novartis, whose global Gleevec sales generated $4.7B in 2011.   Many US patients are now finding that the Gleevec price has skyrocketed at the same time that insurers are requiring them  to pay a much larger share of its  hefty price tag.  The situation is quite simply unsustainable.

One person who signed the online petition shared:

I started taking Gleevec June 1, 2001, when it was first approved by the FDA. It cost $2400 for 30 pills. Now, these same pills cost $7367 per month. I pay $1035 per month for insurance to cover this cost. My insurance Co. gets billed for the drug. Why has Novartis raised the price so much? …

A look at  Costco’s online pharmacy, which has a reputation, anecdotal at least, for offering “good value” retail prices on Rx meds in the US, found the following cash price for a month’s supply of an  average dose (dosage  is individualized) of  30 tabs :  GLEEVEC 400 MG TABLET      $6,264.59

While Novartis is continuing its drag on its patent fight to combat the imatinib generics already on the market in India, these cannot yet be exported to the US.  The original  US patent for Glivec expires in 2015. In 2009, Sun Pharma  filed for and received tentative FDA approval for a generic imatinib for when that day comes.

Given the power of the pharma lobby the future remains very uncertain for any relief on the price of Gleevec , but the clamor of voices from the grassroots is a healthy development.

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Recent developments in Washington and neighboring Oregon are reminders of the clout and lobbying power of Big Pharma on the local level.

Seattle City Councilmember Tom Rasmussen announced that he was working to implement a  discounted prescription drug program for Seattlites , a program of the National League of Cities.  At first glance this might seem like a boon most of us, cash-strapped and increasingly uninsured and underinsured, but in reality the plan is not needed, won’t offer much in the way of bargains, and is linked to a questionable PBM. With all due respect to Rasmussen, who undoubtedly has good intentions , he seems unaware that we already have a drug discount program available at no charge to all state residents, the Washington Prescription Drug Program , which offers discounts up to 60% on generics and 20% on branded drugs, while the NLC program  offers maximum discounts up to 23% of full retail prices.  Another concern is that the NLC card is an offering of CVS Caremark, the mega-PBM which has earned itself notoriety for  unethical business practices, including overcharging government employee health plans ( including the federal plan) for Rx medicines and drug-switching on scripts. The Seattle-only program is due to start next month, so now is a good time to weigh in with Rasmussen and his fellow City Councilmembers , as well as with Mayor Mike McGinn on the issue.  In addition to helping to increase awareness of the WPDP, our city elected officials could really offer a public service by creating a drug price comparison tool that surveys Seattle pharmacies.

And in the Washington Legislature, among several bills dealing with prescription drugs ( look for my comments in the future), for the third year in a row we saw  Drug Companies Fight Take-Back Program for Unused Medicine. They claim that take-back programs, which they would be required to help pay for, would do little to stop  abuse of prescription drugs and that environmental concerns about trashing meds are essentially bogus. Take Back Your Meds, a group of over 260 health organizations, police, drugstores, local governments, environmental groups and concerned individuals vows to keep up the fight.

In Oregon, a legislative defeat with direct negative impact there and for partner WA in the Northwest  Drug Purchasing Consortium , pharma and insurance industry muscle united to make sure that  Oregon Prescription Drug Program Bill Dies a Second Death. SB 1577 would have required all state agencies to purchase medicines for beneficiaries through the Oregon Prescription Drug Program, reversing the current optional  status.  When the OPDP and the WPDP were created in 2005, they formed the Northwest Prescription Drug Purchasing Consortium to achieve better prices through pooled volume purchasing but left participation optional for state agencies. In both states, for example,  the Dept. of Corrections does not participate.  And with efforts to control Rx costs stymied, we are seeing scenarios such as this year’s state budget proposal in Washington to eliminate completely prescription drug coverage for adults in the Medicaid program, only now with some hope of possible mitigation if competitive bidding for generic drugs is approved by the Legislature now in Special Session.

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As the new year starts, some ome items of note from near and far:

The breast implant scandal strips away the glossy euphemisms of cosmetic surgery

S. Korea approves Asia’s first anti-leukemia drug

Nicotine Gum and Skin Patch Face New Doubt

No Benefits for Sick Job Seekers: After battling leukemia, man is denied unemployment benefits

Opinion: Why are Washington’s nonprofit health insurers sitting on huge surpluses?

“Gizmo idolatry,” robotic prostatectomy, and real data

Final Thoughts from A Dying Cancer Researcher

Number of uninsured in WA hits 1 million

Drug research routinely suppressed, study authors find

FBI crackdown on unproven stem cell therapies

 

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Now more so that ever, learning of positive developments and new efforts of those working to make a difference, helps me to keep going . I share here with you some news of significance at the local, state,  and national levels.

In Washington State:

State lifts three-visit ER limit for poor patients

Workers’ wellness saving jobs in parks, policing, transit

Poor people win: Judge allows 11,000 to rejoin Basic Health

In New York State:

Medicaid team passes four sets of reform proposals, including Safe Rx  to “Promote Language Accessible Prescriptions”

Governor Cuomo Issues Executive Order to Improve Access to State Services for Non-English Speakers

Nationally:

One Million Young Adults Gain Health Insurance in 2011 Because of the Affordable Care Act

For kids in foster care, law now requires that states create protocols and actively monitor the use of psychotropic medications

Launch of Pharmacists United for Truth and Transparency

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Recent news and commentary of note on US and global issues related to health and well-being:

Medicare Part D Ups Patient Compliance, Reduces Hospital Costs

Why do 70 dead in Norway rank higher than tens of thousands in Somalia?

For-Profit Hospices Keep Patients Longer, Push Costs Up

Where’s the Advocacy, Komen?

Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

Big Pharma wants to ‘friend’ you

Drug prices to plummet in wave of expiring patents

Two Steps Forward, One Step Back on Hospital Transparency

The most and least expensive cities for health care

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Can We Afford Personalized Medicine?

Special treatment for ‘high profile’ patients; exasperation for the rest of us

Health Insurers Making Record Profits as Many Postpone Care

People Who Donate Organs For Transplants Can Have Difficulty Getting Insurance

Foundations, Conflicts Of Interest And Drugmakers

Mission Crash: The Intolerable Policy Incoherence in US AIDS Policy, Global and Domestic

 Office of Minority Health Awards Major Project to Support
CCHI’s work on Healthcare Interpreter Certification

WA Governor signs precedent-setting healthcare worker safety laws

Washington is first state in nation to ban toxic pavement sealants

HHS awards $4.9 million to support families of children with special health care needs

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The article Efforts to Undermine Public Health:  Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices in the Jan.13 issue of  American Journal of Public Health focuses some much-needed attention on a serious and growing problem , which directly impacts the creation of rational health policy.  It’s also good to see the wide media attention being given to the study, which has been flagged by venues across the spectrum, including  healthcare sector analysis and investigative reporting blogs to mainstream  business media and news reports.

It’s been interesting too,but not surprising to see, that a number of people are also sending identical comments to multiple venues  which covered the story, some to decry the findings of the study, or  to make  off-topic remarks. The comments from the National Health Council , for example emphasized that it has a policy of requiring member groups to have internal disclosure policies regarding industry support received. The NHC itself  has a listing of funding received in 2009 from its  many “Corporate Partners.”   However, just like with payments to physicians, merely acknowledging industry funding doesn’t mean that it does not influence the actions of the recipient, nor not create conflicts of interest.  Unlike the significant body of research on the topic of influences on the prescribing practices of doctors (which have found that while many  state that they themselves are not influenced by pharma gifts and perks, they believe that their colleagues are) , much less attention has been paid in the US to the phenomenon of  industry support of HAGs and its impact on public policy.

Based on personal observations both as  patient and a healthcare professional , I believe that the “don’t bite the hand that feeds you”  phenomenon  relating to HAGs, contributes to  the present inaction on getting states and federal government to do something about the exorbitant and escalating price of medicines as a public health measure. Until the electorate actively protests what is going on, the lobbying power of the biopharma industry  on Congress will remain in effect. While it is becoming more common to find  media pieces highlighting  complaints by provider and  disease groups  about the price of Rx drugs, along with the unaffordable co-pays for those insured, almost never do we hear patient advocacy groups demand that something be done about the situation.  The only logical conclusions that seemingly can be made about the scenario is either that the public is incredibility naive about how the pharmaceutical  and insurance  industries  function, or else HAGs have been so influenced by their pharma benefactors that recipients actually believe that the prices are justified by R & D costs, and that patient assistance programs ( PAPs) are a genuine access solution.  Likely it’s some combination of factors.  More about this later.

Since a requirement that  HAGs disclose industry funding was dropped from Sunshine Act provisions incorporated in the ACA, it’s time start to address the problem by pressing the IRS to require that all 501(c)3 charities disclose their funders and amounts received from each. At the same time, much more public education  is needed about  “the ties that bind”, to paraphrase the title of a 1999  report on the topic  by Health Action International.

In the meantime, those interested in starting to research  industry links to patient and disease groups will find the following resources of independent organizations helpful:

Essential Action
Pharmafiles database: Patient and Health Groups and Their Corporate Funders
Patients, Patents and the Pharmaceutical Industry

Knowledge Ecology International
Medical professional and patient group funding by drug and medical device companies

Healthy Skepticism


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I’m catching up on my reading now, so passing on links to a number of  important studies , some ongoing , published in late 2010, including:

Public Citizen
Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act

MSF/Doctors Without Borders
Access to Essential Medicines: Ten Stories That Mattered in 2010

ProPublica
Dollars for Docs: What Drug Companies are Paying Your Doctor

American Medical Students Association
AMSA PharmFree Scorecard 2010 : Conflict of Interest Policies at Academic Medical Centers

and in the news Supreme Court Reviews Data Mining & Free Speech

Also of  note, the upcoming conference of the National Legislative Association for Prescription Drug Prices :NLARx Meeting on Drug Pricing & Affordability, Friday, January 21, 2011, Washington D.C.  


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Beyond the challenges planned to overturn the Affordable Care Act in the US, we need to keep abreast of news  from around the world affecting access to care , such as these headline stories:

HIV Patients May Soon Face a Choice: Full Price Meds or No Meds At All

U.S. Backs Drug Firms in Lawsuit Over Prices

Deadly Spin Strikes a Chord

Firms fight move to obtain cheap anti-blindness drug Avastin

and from North America, illustrating that it’s not only quality control and manufacturing issues, but the profit motive that contributes to shortages of important drugs:

Report warns of medication shortages across Canada

A push to ease prescription drug shortages: Sen. Klobuchar to propose easing imports of medication from abroad

Darcy Malard-Johnson, a pharmacist at the University of Minnesota’s cancer clinic, said 13 of the 150 drugs on the current shortage list are cancer drugs. Most have been around for years, she said, and that may be one of the problems. Because they’re generic, they’re not as profitable to make or sell as newer drugs. And there’s no way of knowing when a company will simply decide to stop making it.

The shortage of oncology drugs in particular was also highlighted in NCI Cancer Bulletin in an article entitled Continued Shortage of Chemotherapy Drugs Causing Concern.

The FDA’s Drug Shortages  website includes current shortages, status updates, and a list of drugs to be  discontinued, per the following terms:

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only.

Health Canada currently does not conduct such monitoring or provide information on drug shortages, actions that the Canadian Pharmacists Association has urged the government to take on quickly to address the serious and growing problem.

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