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Archive for the ‘Lobbying’ 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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Recent news of note:

Report: Debt Collectors Work In Emergency Rooms, Demand Payment Before Patients Receive Care

Abbott To Pay $1.6 Billion To Settle Depakote Probes

Discrepancies on Medical Bills Can Leave a Credit Stain

American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics

Insurers back FDA plan for new drug category

Patients Share Of Expensive Specialty Drugs Is Rising

Racial, Socioeconomic Disparities Alleged In Autism Spending

Premera tries to gut drug benefits, Kreidler says no 

and a shout out to an excellent source of news and analysis with a focus on Oregon and the broader context:

The Lund Report: Unlocking Oregon’s Healthcare System

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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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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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Things are still beyond grim as the work on Washington State’s  budget continues. However, on February 4, there was a more hopeful sign when the  Senate approved its version of the Supplemental Budget, including a provision to continue the Basic Health Program, although in reduced scope, by drawing on the Life Sciences Discovery Fund. The  LSDF was established in 2005 from WA’s share of national tobacco settlement funds.  Both the Governor’s budget and the one previously approved by the House had cut  BHP, along  with the DSHS long-standing  interpreter services program for  Medicaid and CHIP patients  These potentially promising developments however have garnered less attention than another set of proposals in HB 1847 ,which would  to sustain funding for BHP by eliminating tax exemptions for Big Banking,  and sales taxes on elective cosmetic surgery and private jets. 

While advocates regard these developments as positive, the struggle is far from over. The Supplemental budget is now undergoing the reconciliation process by both houses and will needs the Governor’s approval; the Biennial budget  will have its turn next. Both contain deep cuts in virtually every area of life affecting Washingtonians, with the worst cuts affecting the most vulnerable populations, especially immigrants and refugees. WA Budget cuts 2011.

The history of these two programs is of particular note at this critical time.  The original intent of the Master Tobacco Settlement Agreement was to fund health services in the states for those affected by smoking.  At the time, Gov. Gregoire, aware that the state would come into additional funds from that source by 2009, planned a move to combine them with private monies to develop a biotech sector.  In a  2005 commentary prescient of current threat of extinction for the Basic Health Program (which began as a 1987 pilot project and became permanent in 1993) the Seattle Weekly had reported:

It will be controversial because originally the tobacco settlement money was supposed to be used to help states offset the health care costs associated with smoking. In 2003, when Gary Locke floated an idea similar to the Life Science Discovery Fund—he called it Bio21—Senate Majority Leader Brown told Seattle Weekly she didn’t like the idea of using tobacco money for biotechnology. “We are one of the few states that has remained true to using that money for health care,” she said at the time. Expect the debate over the best use of the tobacco money to continue.

As I had written previously, in late October 2010, after the Governor had issued her call for “across the board budget cuts” from every state agency, the LSDF awarded $5 million to a private company engaged in personalized medicine research.  Last week, LSDF awarded $600,000 in commercialization grants to four research projects.

The Interpreter Services program also was created as a result of federal litigation, in this case as a result of a 1991 Consent Decree negotiated with the Office of Civil Rights in response to lawsuits and civil rights complaints filed against DSHS for failing to provide equal access to services for clients with limited English proficiency  By law, in this case the Civil Rights Act of 1964, title VI, recipients of federal funds must not discriminate against program beneficiaries on the basis of race, color, or national origin.  Courts have defined lack of language access as a form of discrimination based on national origin. However, the responsibility to fund language services is ultimately that of providers. Since  techncially Washington funded the DSHS program voluntarily, it is now able to seek to de-fund it, unlike other mandatory programs. But in doing so, the state would also forgo specific federal funds that it has been receiving that have covered 50-75% of the total costs, as the Washington State Coalition for Language Access explains in a fact sheet:  WASCLA DSHS Interpreter Services Talking Points January 2011

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A front-page article published on February 1 by  The Seattle Times, now the Emerald City’s  sole remaining daily newspaper, purporting to describe new state demographic trends, is causing outrage at a very critical time. At this very moment  the draconian cuts proposed by the Governor to balance the budget, are the subject of  contention in the Legislature  as advocates  struggle to convince lawmakers to preserve at least the semblance of a safety net .  The program cuts would disproportionately affect poor immigrants and refugees and communities of color, as the planned terminations cut deeply into a range of services from state food assistance, citizenship programs, Medicaid medical interpreter services, to health insurance plans which now cover noncitizen adults and some 27,000 children enrolled in the Children’s Health program of Apple Health for Kids, among other vital services.  In addition, other bills being considered would promote racial/ethnic profiling of state residents, including requiring citizenship checks of applicants for drivers’ licenses to those targeting youth for incarceration on the basis of presumed but not proven gang affiliations.

So it seems like more than a coincidence that the Times story Illegal-immigrant numbers in state jump 35% in 3 years was published the day before the Senate Ways & Means Committee was to hold a hearing on the 2011 Supplemental Budget bill which encompasses all of the cuts. The Times article discussed a just-released report from the Pew Hispanic Center  entitled Unauthorized Immigrant Population:
National and State Trends, 2010,
about  results of the Census Bureau’s Current Population Survey. Beyond  just the damage that the inflammatory  and dehumanizing language of the article’s title can cause in the court of public opinion , it turns out that reporter Lornet Turnbull  got his facts wrong too.  Subsequently Jeff Passel, one of the authors of the Pew report, was interviewed by a reporter for local radio station.   Passel said that based on the Census data, there was no evidence that Washington’s undocumented population had increased, pointing to the high margin of error in the data analysis and its very small sample size, and more pointedly, that the Seattle Times had not done fact-checking with Pew.  The  Feb. 3 interview Dispute About Growth Of Undocumented Immigrants In Wash. can be heard in its entirety on the KUOW website.

In these desperate economic times, articles like this one in the Seattle Times serve only to scapegoat all immigrants for the economic woes of the state (and the nation) instead of focusing on the genuine causes of the recession.  Over 400 comments  have been posted in response so far, most of them of a hate-mongering nature.  Recognition that Washington’s regressive tax structure means that all of us contribute at the same (sales tax) rate to state coffers, regardless of immigration status or income, is handily overlooked by the ranters. Interestingly, the Times has posted a partial correction to the article, explaining that undocumented people constitute a small  fraction of the state’s population

A previous version of this story incorrectly stated that illegal immigrants accounted for nearly 5 percent of the state’s population, giving Washington the seventh highest rate of illegal immigrants in the nation. A Pew Hispanic Center report, on which the story was based, incorrectly attributed the percentage and ranking to Washington state rather than to the District of Columbia. The center has corrected the information in its online report to reflect that illegal immigrants comprise 3.4 percent of Washington state’s population, a rate that does not rank it among the top 10 states.

The story’s problematc title and other content inaccuracies however remain the same, its damage done.  Use of attention-grabbing headlines is a journalistic technique of course; likewise  fewer readers ever bother to go back to read corrections.

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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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