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Archive for the ‘Lobbying’ Category

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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The end of the year with its annual holidays found many  of us here in Washington State feeling anything but in a festive mood, given the imminent decimation of core health and human services, as part of  the Governor’s proposal for balancing of the state’s  budget in the new year and for the biennium.  On September 13th, Governor Gregoire’s Executive Order 10-04 instructed all state agencies to make reductions in their allotments from the State General fund in order to meet the requirement for a balanced  budget. On September 29, DSHS issued its initial plan of how the 6.3% across-the-board budget cuts would be applied to Department programs to meet this mandate. The proposed cuts were aimed at every program and service (included some entirely state-funded and other linked to Medicaid)  not technically defined as “mandatory,” affecting the state’s most vulnerable populations in all age-groups from pre-cradle to grave, and including  primary care delivered at community health centers.

By December, a supplemental budget proposal with even worse news was issued, containing further  proposals for achieving the needed $4 billion in savings to balance the budget. The drastic cuts to almost every aspect of civic life, was driven by outcomes of  ballot measures  from the November elections, which dashed any hopes even of short-term new revenue generation  from snack sales, rejection of a first-ever state income tax to have been levied only on the wealthiest among us, and hamstrung future legislative efforts to raise taxes with the 2/3 majority approval stipulation.  By December 30, the Governor released the latest list of planned budget cuts,and the timeline for their elimination. While some of the worst of the cuts have been staved off or delayed temporarily, it still remains to be seen whether the remaining services will be funded, even in vastly reduced mode, and how many human beings affected by the cuts will even survive.

While at this stage in my life nothing surprises me any more, the discrepancy between what is happening to these most basic of services and the treatment of the high-profile, socially attractive high tech sector by state government should be a wake up call to all of us who value a decent society. While the majority of Washingtonians have not misbehaved, it seems like the most vulnerable among us are being singled out for punishment.

State Dollars > Private Venture

During exactly same time period that the budget cuts were first announced in October, another state agency, the Life Sciences Discovery Fund, gave a grant of $5 million to a private, for-profit business, the Omeros Corporation, a Seattle biopharmaceutical company, for  research into speculative personalized medicines. The grant to Omeros was rolled into a package deal for the firm, that included $25M from Paul Allen’s Vulcan Capital. Even Xconomy: Seattle‘s biotech reporter Luke Timmerman expressed great surprise at this development in his Dec. 14 article entitled Life Sciences Discovery Fund Debunks Perceptions with Omeros Deal, Shows State Can Bankroll Companies. If the research ever pans out, then there is the possibility of financial returns to the state at some unknown time in the future.

A bit of background: Washington’s Life Sciences Discovery Fund was established by the Legislature in 2005 to disburse the tobacco settlement funds allocated to the state. While the the fund originally had been allocated $350M for a 10-year period, when the State’s budget crisis threatened to shut down the program in 2009, it survived with a budget cut of 41% or $39M in funds for FYs 2009-2011. The LSDF’s  stated mission is as follows:

The Life Sciences Discovery Fund supports innovative research in Washington state to promote life sciences competitiveness, enhance economic vitality, and improve health and health care.

which the  program website further explains as intending to “foster growth of the state’s life sciences sector and improve the health and economic wellbeing of its residents.”

But given the crisis situation we now face–in context of course of the ongoing national recession–emergency measures are needed.  It hardly seems the time for state government to be investing in private companies, purely ethical issues aside for the moment. Obviously, it’s going to take more than redirecting the “mere” $5M given by the LSDF to a private venture to save public health services in Washington State, but those funds certainly could have turned things around for a good number of the axed programs, such as the Basic Health Program insurance plan and so many Medicaid services.  While research is important, without access to care, medical innovations are meaningless.  What good is research, if there is no safety net? Given the LSDF’s mission, it should be part of the logical solution needed  now: making sure that all Washingtonians can benefit from the medical knowledge available today. And the state government can take a leadership role too in education on the need for investment in our human capital. Despite laments over the election outcomes,and grim prognostics, the official ChooseWashington.com website continues to highlight the array of attractive tax incentives, some of which I had commented on previously, for certain types of companies to set up shop here, along with the absence of a personal income tax.

Another part of the Governor’s plan to balance the budget, announced December 14, is to eliminate Boards and Commissions. No mention was made in this announcement, however, about the status of  a brand-new board, the Global Health Technologies Competitiveness Board established in July 2010, after SB 6675 Creating the Washington global health technologies and product development competitiveness program and allowing certain tax credits for program contributions, was approved by the Legislature and signed into law by Gov. Gregoire. Per RCW 43.374.010, among the Board’s charges are seeking funding from the private sector, foundations, and the federal government in order to issue grants to local enterprises …to stimulate our economy and foster job creation in the emerging field of global health while improving the health of people in our state and the world. The program is required to be administered by a 501(c)6 tax-exempt nonprofit organization, which contracts with the Dept. of Commerce for administrative services.

The Global Health Technologies Competitiveness Program (GHTCP) was awarded $1M by the Legislature (evidently not subject to the budget cuts) and issued its first RFP in mid-November, with awards expected to be announced early in the new year, along with a second RFP announcement, according to the Washington Global Health Alliance.

Think Globally, Act Locally ?

These new developments beg the question of just exactly what these specific state-funded programs are doing to improve the health  of Washington residents in the here and now. I write these words from the perspective of understanding full well how domestic and  international health are inextricably linked, whether regarding diseases rapidly transcending national borders or concerning the impact of international trade agreements on availability of medicines for US Medicaid programs, just to name a few examples. I myself am alive today partly as a result of medical advances developed here in Seattle, and I am also directly involved with both local and global health equity work, which makes me even more appalled at what is going on. Global health has been described as Seattle’s “next hot industry,” but few are the public voices applying critical thinking skills to analyze what this actually means for local folks. One of the exceptions is that of Seattle journalist Tom Paulson, who now offers insights on his Humanosphere blogsuch as a November 2010 story on a still-vague, 5-year  $1M  Swedish Medical Center pilot project called Global to Local targeting two low-income communities in  South King County.  Tom pointed out the irony  of this program being rolled out at the very same time that well-established and proven-effective, public health services are being slashed. According to the article, G2L is based on a concept that the “best practices” used by local actors in overseas health programs can be applied here at home too, while structural reasons for domestic health and healthcare inequalities are not addressed. And another observer, Steve Gloyd, MD of Health Alliance International and the UW Dept. of Global Health, has opined that there can be an upside to calling global health an “industry”:

“Maybe using the word will shock people into recognizing that when a local biotech firm says it is working on a vaccine to help people in Africa, some will see it is actually just trying to make a few people in Seattle rich.”

Next year, a new nonprofit called Global Health Nexus will commemorate the 50th anniversary of the Seattle World’s Fair with a major conference and exhibition showcasing the region’s global-health advancements. One has to wonder if anyone working to improve health at the local level will be invited to present, or if we’ll be able to afford the registration fees. Perhaps advocates can submit an abstract for a session there featuring real-life Washingtonians sharing first-hand accounts of the outcomes of state budget cuts on preventable health problems, such as  a child who has  been experiencing asthma attacks since elimination of the Children’s Health Program; an adult with diabetes who had to get their leg amputated due to lack of non-emergency podiatry care;  or the relative of a patient who died due to a wrong diagnosis resulting from lack of a medical interpreter;  or we could show  videos of overflowing ERs full of patients bumped from the Basic Health Program and unable to be seen at community clinics. Then maybe we could pass the hat among the rich and famous to take to up a collection for local health.

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That might be the conclusion drawn by readers of a recent article in Bloomberg Businessweek. Recession Causing Cancer Patients to Quit Life-Extending Drugs which was the August 4 feature in  the Executive Health column. This news story earned billing as  the Outrage of the Week in  NLARx News from the National Legislative Association on Prescription Drug Prices.  The original article discusses the dire plight of patients  in California with GIST ( gastrointestinal stromal tumor) who lost their jobs and hence insurance, and  are no longer able to afford the Gleevec which has been keeping them alive to the tune of $5000/month.  Or for those who still have insurance, the unaffordable cost of the co-pays, often 50-70% of the Rx retail cost, in accordance with the now-common tiered formulary systems.  Equally outrageous however is that the article completely misses the boat when discussing remedies for the situation.  Author Amanda Gardner describes how patient assistance programs (PAPs) may be available temporarily for some patients as a stop-gap measure, and posits how things should get better  as the provisions of  the Affordable Care Act  roll out.  In the meantime, however,  the very survival of many of the patients  described is in jeopardy  with no solution in sight, if we are to believe such spokespeople as  Stepehn Finan, senior policy director of the American Cancer Society’s Cancer Action Network , who was quoted stating that [the PAPs]

…….. are the only real options at this point for people who are pressed to afford their prescription costs.

Yet the urgent need for something to be done about the exorbitant price of drugs  is not mentioned in this article. Unaffordable medicines are not inevitable. Real remedies exist such as allowing CMS to negotiate for drug prices like the VA does,  instituting price controls, and allowing  prompt development of generics of the most costly drugs. The grip of Big Biopharma  lobbyists on Congress will remain strong if the public continues to believe that nothing can be done.

For the record, the vast majority of funding for the research that led to creation of Gleevec came from government coffers and nonprofit sector sources, and drug’s first US patent expires in 2015.

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Allison Bass’ most recent blog post should serve as inspiration to all , especially to those who think that nothing can be done:

Fighting for lower drug prices, or how to counteract Big Pharma’s lobbying

She gets right to the point with her analysis and recommendations:

Why? The reason is glaringly obvious: Congress won’t give the Department of Health and Human Services (HHS) the authority to negotiate lower drug prices because too many of its members are in bed with the industry. That’s why HHS was expressly prohibited from negotiating lower drug prices in the Medicare Part D legislation enacted during the Bush administration.

<snip>

It’s difficult for individual consumers to have much of a voice in the face of such well-oiled (forgive the pun) special interests. But it doesn’t hurt to try. So I will repeat what I told the Mount Holyoke crowd: Pick up the phone or write a letter/email to your Congressional representatives telling them that you want Congress to pass a law giving HHS the power to negotiate lower drug prices for Medicare and Medicaid (and while you’re at it, ask for a ban on direct to consumer advertising too).

Obviously this was a select crowd she was speaking to, but the message is clear and vital for us all. Time for everyone to become a broken record on the topic.

Allison is a journalist and medical writer, and author of the book  Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial.  Her blog focuses on “the serious flaws in our health care system and the need for reform.”


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Little-known issues considered by Washington Legislature become or remain Law: Who Benefits? Part 2

Another piece of 2010 legislation that is destined to affect the  pocketbooks of consumers was a measure backed by the Washington State Medical Association to allow doctors to engage in “balance billing. ” This practice now banned in 47 states for insurance plans’  in-network providers, and for the entire Medicare program. Balance billing  refers to charging patients for the difference between the  dollar amount that a physician or other provider bills for a service, and the amount that an insurance company is willing to pay. Despite the fact that both parties, i.e. providers and insurers ,may have negotiated an agreed amount per service, some providers persist in billing the patient for the remaining balance above the contracted price. According to the recent report Unexpected Charges: What States Are Doing about Balance Billing,–prepared for the California HealthCare Foundation by Georgetown University’s Health Policy Institute, and the National Academy for State Health Policy –laws to regulate balance billing began focusing on managed care plans, and increasingly extended the scope of consumer protections to HMOs and also PPOs.

Balance billing can bankrupt insured patient families, as the Kaiser Health News reported early this year:

The Price They Paid :How a Virginia family got permission to get out-of-network treatment for one son’s heart defect, and still ended up drowning in debt.

Other major media reports on the topic included 2008 articles in Business Week and the Wall Street Journal. A blog piece and companion article in were just published  April 30 in the New York Times, describing the controversial and often illegal practice of balance billing. A Medical Bill You May Not Have to Pay links to the article on troubleshooting one’s medical bills, and also discusses the additional problem that the new federal health care reform law does not directly remedy unfair business practices like balance billing.

There seems to be limited information available in the public domain about the lobbying efforts that went into the success in blocking the proposed ban on balance billing in Washington.  The legislative analysis section of the Washington State Medical Association‘s website is restricted to members only. A brief legislative report on the topic is available on the site of the Washington Association of Health Underwriters:

House Kills Controversial Measure Regarding Coverage for Emergency Health Care Services. The House Ways and Means Committee has killed HB 2779—a measure that was intended to clarify the circumstances involving coverage for the delivery of health care services by non-participating providers, and to prevent balance billing. The bill was killed when it was not brought to a vote before the cut-off for committee action. The measure was introduced by Rep. Eileen Cody, Chair of the House Health Care & Wellness Committee. Rep. Cody argued that consumers need to be protected from balance billing by non-participating providers. The Washington State Medical Association, together with the Washington State Hospital Association and the American College of Emergency Physicians testified in opposition to the measure. The WSMA hired former Insurance Commissioner Deborah Senn to testify in opposition to the bill. Opponents argued that the bill amounts to price-fixing, and damages Washington health care providers who are already paid less than providers in other states under Medicare. A companion bill in the Senate—SB 6400—was also killed in committee when it was not brought to a vote before the cut-off for action

It is of note that  banning balance billing at the very least for emergency care, is considered best practice, as patients need to be able to receive care based on proximity. And in the case of accidents, patients are brought to a facility by first responders. It should go without saying that ER patients, even if conscious, certainly cannot  be expected to interview the members of a facility’s medical team to determine if all of them participate in the network of a patient’s insurance plan. Even for planned surgeries, it is usually impossible for patients to learn whether or not all providers who will be involved in every step of the procedure, belong to the patient’s insurance network.

The  defeat of  this Washington legislation was hailed at the national level by the American Medical Association:

Physicians’ right to balance bill protected in Washington State,  AMA Advocacy News, March 22, 2010.
The Washington State Medical Association (WSMA) achieved an impressive legislative victory this month. WSMA defeated three bills (H.B. 2779, S.B. 6400 and S.B. 6532) that would have prohibited physicians’ right to balance bill. The AMA worked with WSMA for several months on the balance billing issue and will continue to work with WSMA and others to defeat similar proposals this year and in 2011

Conclusion:  Parts 1 & 2

What do the developments discussed these two posts mean for Washingtonians? For starters, we need to learn more about these issues, do the necessary opposition research, and take action to make sure that access to care is genuine.

Regarding medical innovations, without access they are meaningless.  And whether it’s providers or insurers who are not playing fair with medical bills, they must be held accountable, with genuine regulation. We need to get hard data on whether Washingtonians are benefiting from the treatment advances developed in our state; the same holds true here and nationwide for all R&D supported by us via federal and other public funding.  We know that Big Biopharma’s lobbying efforts on the biologics pathway got their desired results from Congress in healthcare reform; the states are targets too.   If anyone still is wondering what’s next, headlines like the following are strong indications of what’s in store, unless popular efforts can restore the political will to do what’s right :

Gaps in insurance policies make oral drugs too pricey for some cancer patients

Despite the somewhat misleading title attributing the access problem just to insufficient insurance coverage, the article goes on to discuss the cost problem and how industry justifies the exorbitant prices.

Another new item of note is this one ,written after the approval last week of  a prostate cancer vaccine whose medical value may still be uncertain, developed by Seattle biotech company Dendreon:

Provenge, a New $93K Cancer Drug, Will Be Extremely Effective — on Taxpayers

This is one reason the price of Provenge was set so much higher than analysts expected: Dendreon knew that patients were covered mostly by Medicare and not private insurance, and that the government’s own rules prevent Medicare from negotiating prices.

’nuff said.

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Little-known measures passed by Washington Legislature now Law: Who Benefits? Part 1

The 2010 Washington State Legislature adjourned on April 12, after the special session called by the Governor to work on budgetary issues still pending at the end of this year’s regular short session. The arduous session focused primarily on filling the gaps created by this year’s $2.8 billion budget shortfall, coming on the heels of the $9B state deficit of last year.  In the realm of health and human services, most state-level advocacy attention naturally was devoted to preservation of the basics and safety net services, and monitoring developments with the federal health care reform legislation. But some bills that became law received limited public attention, including those which can directly impact Washington’s goal of access to affordable and appropriate health care for all by 2012 , and for all children by 2010.

While the  language of SESSB 6143, said that it was about Modifying excise tax laws to preserve funding for public schools, colleges, and universities, as well as other public systems essential for the safety, health, and security of all Washingtonians, in it’s final version,  Section 1101 , subsections 2a & 2b, contain an exemption from the temporary Business & Occupation tax surcharge for hospitals and institutions engaged in scientific research and development. For readers who are not Washingtonians, this temporary fix was proposed to help fill the dire budget shortfall, because our state does not have an income tax  and relies heavily on sales tax revenues — now greatly diminished– to fund services.

While the bill was being considered, the Seattle Times reported only that

It would increase from 1.5 to 1.8 percent the B&O tax paid by service businesses, with exemptions for hospitals and research and development. A tax credit for small businesses would be doubled.

Meanwhile, GenomeWebNews ran a feature story entitled Non-Profits, Investors Worry About Proposed Washington State Tax Surcharge Increase, describing how venture capital firms along with many research institutes and spin-off companies, joined forces  in fighting the proposed B&O tax surcharge hike.

After passage, the Times wrote about Why the Legislature ended up relying on ‘7-11’ taxes explaining that

Instead, the Legislature passed a $780 million tax package that included more than $250 million in new taxes on candy, mass-market beer, cigarettes, bottled water and soda pop. In other words, the vices of the Average Joe.

GenomeWebNews, to date one of the very few outlets to report details of the outcome of this proposed legislation, described in an April 22 article  Institutes, Companies Exempted from Washington State Tax Surcharge Increase how the thriving biotech  and biomedical sectors got their way:

Chris Rivera, president of the Washington Biotechnology and Biomedical Association, told GenomeWeb Daily News his 460-member organization organized its government affairs council, its Board of Directors, and key life-science organizations to lobby for an exemption to the tax hike.

“Literally within 48 to 72 hours, we mobilized our members in the life science community. And probably within a week to 10 days, we had an exemption,” Rivera said.

In 2008, the Washington life sciences sector is reported to have generated an estimated $6.4 billion in revenue. statewide. On the national scale, the University of Washington is the  #1  public university recipient of federal research funding, and the #2 such recipient of funding from the  National Institutes of Health. According to the state website on the sector, Washington is home to over 190 nonprofit organizations and 594 companies engaged in life sciences research and development, and employs some 14, 300 people. Big institutional names  here include the Fred Hutchinson Cancer Research Center, PATH, the Bill & Melinda Gates Foundation. Seattle BioMedical Research Institute ,WSU,and the Institute for Systems Biology, along with many smaller nonprofits and companies. Many of them will also be found listed as among major recipients of taxpayer funding, Washington was said to rank 7th among all states as a recipient of NIH funding, having received a total of $755 million in 2008.

The high tech sector has been receiving  state tax breaks (and from some cities and counties as well) for some time now. Since 1995, per legislation that became RCW 82.63,  there have been state sales tax exemptions for facility construction and purchases of eligible equipment , followed by  later legislation authorizing B & O tax credits for tech R & D expenditures. Entities that utilize benefits of these programs must report details annually to the WA State Legislature. The Descriptive Statistics for Tax Incentive Programs  2009 Report for calendar year 2008, published by the state Dept. of Revenue, reveals that dollar value of the sales tax exemptions  for this sector was $122.5 million out of a total  $194.1M  for all participating industries;  and that 481 companies received B&O tax credits that saved them some $22M . The other state tax incentive programs are primarily for the farming and timber sectors. The report explains in detail how the program works, and that

The original law provided the deferral/exemption only for a ten-year period.  In 2004 the
expiration date was extended to January 1, 2015.

Interestingly, at that time (2004) the Seattle Times commented:

.….the industry’s political clout has never been stronger. Along with high-tech lobbyists, the biotech group won a battle in Olympia earlier this year to extend multimillion-dollar tax breaks for the industry to 2015, despite the state’s budget woes.

A March 2010 editorial by local venture capitalist  Robert Nelsen in Xconomy-Seattle, entitled  Olympia: Don’t Crush Biotech With New Taxes. opined that the exemption from the temporary B &O surcharge would cure the problems of both high unemployment and high healthcare costs in Washington, all while improving the national economy.  However, the evidence he offered in support of his belief that that the “wrong” action by state legislators  would be the death of the industry seems pretty thin. In addition to the usual warning that jobs will be lost because companies will locate or, relocate, to locales with more favorable tax laws, the sole examples he offered about how the bioscience  industry reduces healthcare costs were

Pharmaceuticals have long been known to drastically reduce costs. New medications have brought down the cost of treating depression by mitigating the need for hospitalization. Likewise, cholesterol drugs have saved our health system billions of dollars by reducing the need for heart surgery…

If only controlling healthcare costs were so simple. While Nelsen has chosen to give examples only of pharmaceutical remedies, he doesn’t mention the problem of the affordability of so many of the newest medicines, most of which are biologics. Biologics are expected to account  for  50% of all new medicines by 2014, and now cost on average, 22 times more than ordinary drugs. Nelsen’s examples are of  2 types of small -molecule drugs, which also happen to be drugs about which there are concerns about effectiveness and safety.  Readers wanting  to learn more about  treatment for depression, and research on cholesterol-lowering drugs will find Consumer Reports Best Buy Drugs , and the Center for Evidence-Based Policy at OHSU to be helpful resources to get started.

Getting back to the topic of this post, the concept of sharing the pain in these tough fiscal times in order to promote the common good,  seems to have lost out once again.

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