Last night Governor Deval Patrick signed MASSPIRG's priority prescription drug marketing reform bill (MASSPIRG release).
"While the bill does not include a complete ban on industry gifts to prescribers it does make a giant step forward in shining the light on this marketing practice through the disclosure of anything of more than $50 value, giving the DPH authority to ban some gifts, and including significant fines for violations of the new regulations," said Deirdre Cummings, Legislative Director of MASSPIRG.
In addition to these and other Rx marketing reforms, the bill requires insurers to use uniform claims codes (expected to save hospitals $50 million annually) and requires public reporting of healthcare-associated infections and serious reportable events.
While lawmakers debate how best to oversee the shift to computerized records, some insurers have already begun testing systems that tap into not only prescription drug information, but also data about patients held by clinical and pathological laboratories. Traditionally, insurance companies have judged an applicant's risk by gathering medical records from physicians' offices. But the new tools offer the advantage of being "electronic, fast and cheap," said Mark Franzen, managing director of Milliman IntelliScript, which provides consumers' personal drug profiles to insurers. The trend holds promise for improved health care and cost savings, but privacy and consumer advocates fear it is taking place largely outside the scrutiny of federal health regulators and lawmakers.
The Fair Credit Reporting Act actually provides stricter controls on medical credit reports than financial credit reports. The FTC has investigated and imposed consent decrees (no civil penalties) on Medpoint and Milliman Intelliscript.
I wish I had time to do a longer blog on how information about your prescription drug purchases is used both for marketing more prescriptions and, paradoxically, as this article shows, insurance denials. For now, read this excellent Business Week story They Know What's in Your Medicine Cabinet:
An untold number of people have been rejected for medical coverage for a reason they never could have guessed: Insurance companies are using huge, commercially available prescription databases to screen out applicants based on their drug purchases.
Here's a fact you may not know: The fastest growing uninsured population in the U.S. is young adults--of the 6.6 million people that have joined the ranks of the uninsured since 2000, nearly half are 19-34 year-olds.
So, Colorado PIRG Student Chapters have launched Colorado Health Care Alert to "question the myth that young adults in the state don't carry health insurance because we think we are invincible! While there may be a minority of young adults who reject health coverage, the vast majority of us want health care but experience difficulty."
Find out what other young people are saying about how the health care crisis affects them. Tell your story, too, at CoPIRG Student Chapters' Colorado Health Care Alert
Ensuring affordable and safe health care is a priority for all the PIRGs. Here's more on our prescription drug and other health care reform programs from MASSPIRG and CALPIRG.
On Thursday, during consideration of mortgage meltdown response legislation, the House overwhelmingly passed on a 256-160 vote (Pro-consumer vote is AYE) the bi-partisan Miller-(D-NC)-LaTourette-(R-OH) amendment. This previous blog has details. Over at the Credit Slips blog, Professors Elizabeth Warren and Adam Levitin discuss the vote. Professor Warren (after noting that even the national bank regulator known as the OCC has previously ceded foreclosure law to the states) makes the following points:
There are no federal foreclosure laws. Any mortgage holder--including a national bank or thrift--must abide by the terms of the state's foreclosure laws. But in the past few weeks, national banks have started making a new argument: state laws are pre-empted whenever a national bank holds the mortgage, so the states can't make them follow the local rules.[...] The scope of this argument is stunning. Because there is no federal foreclosure law, would the banks be free to do whatever they wanted? Could they simply order families out of their homes? Would federally-charted banks start buying up troubled loans from other banks, then doing their own vigilante expulsions?
I would only add that for those who believe that we need a legal and policy marketplace with 51 or more -- not just one -- innovation centers, it's nice when we win, even when it appears that the correctness of our position is obvious to anyone with knowledge of the subject. But wherever they can, powerful interests are seeking to make it harder for consumers to obtain justice in the state courts, for state attorneys general to exercise their traditional police powers to protect their citizens and for state legislatures to act as laboratories of innovation. More than a few of the powerful interest efforts can be characterized as vigilante policy power plays, but the current courts and administration players are largely with them. We must exercise eternal vigilance to hold their efforts back.
Note that our letter refers to Miller-LaTourette as an amendment to HR 5830, the American Housing Rescue and Foreclosure Prevention Act. HR 5830 became part of a floor package known as HR 3221, which after consideration of a variety of amendments, passed the full House but faces a complicated road, as noted in today's New York Times story Housing Bailout Bill Seems to Be on Shaky Ground by Stephen Labaton and Steven Weisman.
The objective of this workshop is to bring together policy makers and experts to debate the proposal to create a new mechanism to stimulate private investments in medical R&D. We will consider the economic, management and legal issues surrounding the use of monetary prizes as an alternative mechanism to stimulate private investments in R&D. This will include, but not be limited to, a discussion of the proposed Medical Prize Fund Act of 2007 (S.2210, 110th Congress) introduced by U.S. Senator Bernie Sanders.
As I pointed out recently:
"It is natural for consumers to distrust monopolies, which can even limit access to medicine. The Prize Fund bill, from U.S. Senator Bernie Sanders (I-VT) shows us that we don't have to tolerate monopolies or the abuses of monopoly pricing to stimulate innovation.
Our colleagues at Essential Action have a new e-newsletter, the Global Access to Medicines Bulletin. Click here to subscribe.
Essential Action today published the debut issue of our new Global Access to Medicines Bulletin. This free bulletin aims to be a reliable and easy-to-use resource for those who want to keep up to date on key issues and the latest developments regarding access to medicines in the developing world.
Our debut issue focuses on a recent review of how U.S. government trade policy affects access to medicines in developing countries.
We anticipate distributing the bulletin electronically every two to four weeks.
The big U.S. papers all have short stories reprising a longer story -- SFO seizes drug giants' documents -- that ran in the London Sunday Telegraph reporting that the UK's Serious Fraud Office (we need one of those) is looking into whether Big Pharma's GlaxoSmithKline and AstraZeneca were involved in illegal "bribes allegedly paid to Saddam Hussein's deposed Iraqi regime." The companies deny all and say they've been cooperating since the Volcker report on the "oil-for-food" scandal listed them and thousands of other firms. From the Telegraph:
The report claimed investigators had uncovered evidence to suggest AstraZeneca had paid $162,000 (£81,000) in bribes to get three contracts worth $2.9m, while GlaxoSmithKline was named as having paid $1m to win nine medicine contracts valued at $11.9m. Both companies vehemently denied the claims at the time.
We are co-amici, with AARP and other leading groups, in an important case before the Supreme Court today, Riegel vs. Medtronic. The case against the medical device manufacturer is being argued by Allison Zieve of Public Citizen Litigation Group. Over at the Consumer Law and Policy blog, her colleague Brian Wolfman has posted an entry linking to key resources on the case, including this previous post.
Virulent bacteria kills 19,000, says hospital infections study
Kevin Sack of the New York Times reports that Bacterial Infection Killed Almost 19,000 in 2005 , according to a new U.S. Centers for Disease Control study of infection caused by a "virulent drug-resistant bacteria" known as methicillin-resistant Staphylococcus aureus.
The state PIRGs have worked closely with the Consumers Union Stophospitalinfections.org campaign to enact state laws requiring greater attention to this serious problem.
International conference on World International Property Organization
On Monday, I will participate in an international conference in Geneva, Switzerland, sponsored by the PIRG-backed TransAtlantic Consumer Dialogue (tacd.org). The conference concerns the activities of the powerful, but obscure, UN agency known as the World Intellectual Property Organization. The Reform of WIPO: Implementing the Development Agenda will examine WIPO's well-known potential to make access to medicine and access to knowledge more affordable for billions of citizens across the globe. The question has always been: But does WIPO have the political will? The event is one in a series of TACD conferences on reforming intellectual property laws.
AMA/doctors sell your info to big Pharma for big money
Over at the Prescription Access blog of our partners the Prescription Access Litigation project, check out the post: AMA sells your Doctor's info to Big Pharma. It's based on an op-ed column Prescription mining raises millions for doctors' group by Robert Restuccia and Lydia Vaias that ran in the San Francisco Chronicle last month. The blog excerpts the full op-ed. Excerpt from the blog portion:
As the op-ed points out, most doctors aren't even aware that their information is sold -- not just by the AMA, but by pharmacies as well. When one of the 100,000 drug salespeople that blanket the country enters a doctor's office, they know exactly how many prescriptions the doctor has written for their drug and for those of their competitors. And they know how the doctor's prescribing habits changed since their last visit -- so they can figure what messages worked, and didn't work, with that particular doctor.
In news releases, leading advocates for low-cost AIDS drugs and other medicines for lesser-developed countries, including Knowledge Ecology International and Doctors Without Borders/Medecins Sans Frontieres (MSF), have praised the Republic of India's High Court in Chennai for ruling against a Novartis patent claim, thereby allowing lower-cost Indian generic equivalents to continue to be sold without royalties. From KEI:
Novartis is complaining that the decision today will undermine R&D by claiming that it needs strong patent protection in India for R&D. India has more poor people than the combined population of Europe and the United States. We cannot depend on high drug prices in poor countries to stimulate R&D.
Yusuf Hamied, chairman of the Indian pharmaceutical company Cipla, also described it as a positive ruling. "If Novartis had won, this would have been a tremendous setback for us," he said. "I am willing to pay a royalty on a new invention, but I am against monopolies. This would have increased monopolies, which would have meant higher prices."
From MSF:
Developing country governments and international agencies like UNICEF and the Clinton Foundation rely heavily on importing affordable drugs from India, and 84% of the antiretrovirals that MSF prescribes to its patients worldwide come from Indian generic companies. India must be allowed to remain the 'pharmacy of the developing world.'
The story in today's New York Times by Andrew Pollack -- Pricing Pills by the Results -- reports that one prescription drug company
is offering a money-back guarantee. Johnson & Johnson has proposed that Britain's national health service pay for the cancer drug Velcade, but only for people who benefit from the medicine, which can cost $48,000 a patient. The company would refund any money spent on patients whose tumors do not shrink sufficiently after a trial treatment.
Such a fund would give large rewards for cures or vaccines for diseases like malaria that affect millions, and smaller rewards for drugs that are similar to existing ones, with perhaps slightly different side effects. The intellectual property would be available to generic drug companies. The power of competitive markets would ensure a wide distribution at the lowest possible price, unlike the current system, which uses monopoly power, with its high prices and limited usage.
In a paper, economist Dean Baker of the Center for Economic and Policy Research explains and compares four alternative methods including the prize system and finds that all do a better job than the current system:
a proposal to require employers to contribute funds to drug researchers, a proposal to compensate patent holders based on the quality and extent of use of their drug, a proposal under which the government would purchase most drug patents and place them in the public domain, and a legislative proposal to establish a group of publicly supported pharmaceutical research centers, which would develop patents for public use...Dr. Baker concludes that all proposed alternatives "hold clear advantages over the patent system," in part because each would allow drugs to be sold in a competitive market unhindered by government-granted monopoly rights.
Updated with our release (same day). Over at GoozNews, Merrill Goozner of the Center for Science in the Public Interest explains that the drug safety bill passed by the House Energy and Commerce Committee "slightly improves the ability of the agency to ensure new drugs are safe and well-monitored once on the market." The bill took some amendment hits. We'll post an update next week from U.S. PIRG's health care advocate Paul Brown detailing which of our priorities made it through the committee's amendment gauntlet. In general, we did get $225 million for post-market drug safety efforts, greater transparency in clinical trials, higher civil penalties and stronger conflict of interest rules for FDA advisory committees. We're disappointed that a number of commitee members supported an amendment that passed, severely weakening the bill's direct-to-consumer ad reforms. Here's more on PIRG's drug safety efforts. Below the jump is our pre-vote early Thursday news release.
For Immediate Release For More Information:
Thursday, June 21, 2007 Paul Brown (202) 546-9707
Energy and Commerce Committee to Consider Drug Safety Bills
U.S. PIRG Urges Congress To Allocate More Money for Drug Safety
(Washington, DC)-The Energy and Commerce Committee is considering legislation today that will protect consumers from unsafe prescription drugs. The safety bills are part of a package of nine Food and Drug Administration-related bills. Earlier this week the Subcommittee on Health passed the bills on a voice vote.
The FDA has faced severe criticism over the last few years for approving several drugs such as the pain reliever Vioxx and antidepressant Paxil that were later shown to cause dangerous side effects and deaths. Most recently, the FDA has been chastised for withholding information about the diabetes drug Avandia that links it to increased risks of heart attacks.
U.S. PIRG urged the Energy and Commerce Commmittee to require the FDA to make the results of drug studies available on-line to researchers, doctors and patients.
"An on-line database will allow doctors and patients to weigh the risks as well as the benefits of taking a drug," said U.S. PIRG Consumer Health Care Advocate Paul Brown. "For too long this potentially life-saving information has been hidden from public view."
U.S. PIRG also urged the House Committee, like its Senate counterpart, to allocate an additional $225 million from drug industry user fees for
post-market drug safety reviews, and to include strong conflict-of-interest rules for scientists who serve on FDA advisory panels.
U.S. PIRG also urged the House to give the FDA the authority to issue hefty fines of up to $100 million for drug makers who fail to complete follow-up safety studies.
"The fines are a necessary incentive to get the industry to do the follow up safety studies," Brown said. "Drug makers have failed to complete 70 percent of these studies."
The Energy and Commerce bills are expected to pass with bipartisan support since they are part of must-pass prescription drug user fee legislation that provides nearly $400 million of the Food and Drug Administration's $1.5 billion budget.
The bills are scheduled to go to the House floor in early July. The Senate already passed a similar legislation by a 93 to 1 vote in May.
"The FDA's system for reviewing the safety of drugs has been broken for a number of years and it has cost consumers their health and their lives," Brown said. "Congress must solve the agency's safety problems."
###
U.S. PIRG is the federation of state Public Interest Research Groups. State PIRGs are non-profit, non-partisan public interest advocacy organizations.
Opponents of fairly-priced medicines go hard negative
I saw a harsh and jingoistic ad Slouching Toward Burma (Myanmar) from the corporate front group USA For Innovation in a Capitol Hill news tabloid this week, claiming that the issuance of compulsory licenses and other legal efforts by the Thai health ministry to lower AIDS and other drug prices were nothing more than some regime taking the money and running. I knew, however, that I could rely on James Love, director of Knowledge Ecology International, to clear the air in his Huffington Post blog, where he explains to others what I already knew:
Thailand issued compulsory licenses on three overpriced drugs, including two drugs for AIDS and one for heart disease. Thailand did this to obtain access to less expensive generic products. Thailand did this in compliance with WTO rules, and the patent owners are free to negotiate with the Thailand government on the royalties for those compulsory licenses.
Knowledge Ecology International also works closely with Doctors Without Borders/Medecins Sans Frontieres (MSF), which has posted this recent speech by its Dr. Buddhima Lokuge, explaining the Thailand health crisis.
Both the WHO (in August 2005) and the World Bank (in August 2006) predicted dramatically rising drug costs in Thailand because of the second-line crisis. The World Bank identified the use of compulsory licenses to produce less-expensive generic medicines as a strategy to address the rising costs in order to continue providing universal coverage for HIV/AIDS treatment to the estimated 200,000 people who need ARVs. It is important to point out again that compulsory licenses are legally recognized means to overcome the barriers created by monopolistic pricing practices.
By the way, I couldn't find the not-so-helpful About Us page at USA For Innovation, until I used various outside-the-site searches, but it does confirm that its director, Ken Adelman (with an A), the former Bush official, is a senior flack with Edelman Worldwide (the link is to SourceWatch, not Edelman), the PR powerhouse with massive PhRMA contracts.
KEI challenges Rx Giant Gilead on AIDS, avian flu drugs
The leading access to knowledge/access to information advocate known as Knowledge Ecology International (the new home of the Consumer Project on Technology (CPTech)), has filed a complaint with the U.S. Federal Trade Commission (news release) alleging that the pharmaceutical giant Gilead is using anti-competitive practices in efforts to "control global markets for active pharmaceutical ingredients (APIs)." From the Huffington Post blog by KEI's James Love):
Gilead Sciences, the firm chaired by Donald Rumsfeld before he became head of the Department of Defense, was in the news in 2005 over its patents on Tamiflu, a drug used to treat avian flu. More recently, health groups, including ours, are looking closely at efforts by Gilead to control global markets for active pharmaceutical ingredients (APIs) not only for Tamiflu, but also for two AIDS drugs, including one invented at Emory University on government grants.
Yesterday, the Food and Drug Administration (FDA) proposed modest improvements to its drug safety efforts. Response from Congressional critics was swift: not good enough. We expect to work with Congressional champions of FDA reform, including Rep. Henry Waxman (D-CA), and Senators Enzi (R-WY), Grassley (R-IA), Dodd (D-CT) and Kennedy (D-MA) and others on a variety of legislative efforts to improve both the funding and independence of the FDA's post-market safety efforts and the transparency of clinical drug testing.
Over the last fifteen years, under pressure from powerful drug manufacturers, the mission of the FDA has been distorted by an increase in user-fee funding that could largely only be used to approve new drugs, without concomitant increases in funding for critical post-market safety reviews. This created an over-emphasis on approving these new drugs at the expense of programs guaranteeing the safety of drugs already on the market. As we pointed out in 2005 comments to the Institute of Medicine:
Since the passage of the Prescription Drug User Fee Act (PDUFA), funding for most of the FDA's critical drug research functions-with the exception of new drug approval-has declined. In the past 11 years, spending on new drug reviews increased from 53 percent to more than 79 percent of the agency's drug center budget.
As the New York Times story F.D.A. Widens Safety Reviews on New Drugs notes today, the expiration of the PDUFA funding has forced the once-omnipotent drug lobby PhRMA to the Congressional table:
The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs. That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.
The urgency of the renewal of the PDUFA user fee program provides an outstanding opportunity for Congress to conduct broad oversight of the FDA and to do a lot more than simply reforming the fee mechanism so some of the money goes to post-market safety. More on PIRG's Safe and Affordable Drugs campaign work here.
More on the Rx vote: Here is the recorded 255-170 vote to pass the Rx negotiation bill HR 4. Here's a news release from U.S. PIRG health advocate Paul Brown:
Excerpt: "We're in a classic David versus Goliath fight -- with seniors, taxpayers and consumer groups representing David and the drug industry representing a Goliath on steroids," said Brown. "Now the battle moves to the Senate where we anticipate fierce resistance from the drug industry." FULL RELEASE BELOW THE JUMP
FOR RELEASE: Friday, January 12, 2007
CONTACT: Paul R. Brown (202) 546-9707 ext 304 or (702) 287-2163 House Passes Medicare Prescription Drug Bill
Legislative Battle Cast As David Versus 'Goliath On Steroids'
The U.S. House of Representatives today voted to allow Medicare to use its bulk purchasing power to negotiate directly with drug manufacturers for prescription drug price discounts.
Congress created the prescription drug program in 2003 with a drug industry-backed bill that explicitly prohibited Medicare from negotiating discounted prices with drug manufacturers.
"Today's vote is a big victory for seniors and taxpayers," said U.S. PIRG Consumer Advocate Paul Brown.
"We're in a classic David versus Goliath fight -- with seniors, taxpayers and consumer groups representing David and the drug industry representing a Goliath on steroids," said Brown. "Now the battle moves to the Senate where we anticipate fierce resistance from the drug industry."
Brown added that the drug industry spends more than any other industry on federal lobbying, campaign donations and congressional travel, and has launched a $100 million campaign to kill the Medicare drug negotiation bill.
Senator Max Baucus, Finance Committee Chair and Senator Charles Grassley, Finance Committee Ranking Member oppose the House bill, and President Bush has threatened to veto it.
"While it's true we face an uphill climb in the Senate, it's also true that an overwhelming majority of Americans--85 percent--want Medicare to negotiate bulk purchase discounts for its drug program, so we've got millions of Davids on our side." said Brown.
News flash in from Paul Brown, U.S. PIRG health care advocate, who's back in DC: "The House passed the PIRG-backed Medicare Negotiation Bill by a vote of 255 yes, 170 no. We got 24 Republicans and lost no Democrats." That's great news, especially that 24 Republicans voted to help senior citizens get better access to low-cost, critical drugs. The bi-partisan vote helps to show that Speaker Pelosi's 100 Hours program is not a partisan game as some pundits have alleged. We have some work to make Medicare negotiation rights law, but it's a great start and shows that the once-all-powerful PhRMA lobby no longer can claim control over what the Congress does on its issues.
Updated with new links 10 Jan 07: California governor Arnold Schwarzenegger has proposed a comprehensive health care reform plan. Any time California acts, it has an important ripple effect, so we're encouraged, but there's a lot of work to be done, and not just around the edges. Here's an AP story with some concerns from labor and consumer groups including CALPIRG's Emily Clayton. Here's Emily's blog post and CALPIRG's news release, which offers cautious support, but then points out some flaws:
The administration's plan does, however, fall short in some important respects. While Governor Schwarzenegger wants to have everyone at the table, employers are largely allowed to skip out on the dinner tab. The modest requirement that employers contribute 4% of payroll to health care costs simply is not enough to guarantee coverage to the millions of Californians that currently lack it.
In today's New York Times, Marian Burros reports that a new study finds that "Research studies financed by the food industry are much more likely to produce favorable results than independently financed research." These important findings are in a study, Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles, published in the important and relatively new online journal PLoS Medicine of the Public Library of Science. PLoS Medicine, like other PLoS projects, is a fully peer-reviewed scientific journal, but unlike most scientific journals, is open-access: it's not copyrighted and it's free to other researchers and to the general public on the Internet. For more on the international open access -- or what's often called the Access To Knowledge movement -- see CPTech's A2K page. Also see the 2005 CALPIRG Report Limited Knowledge: How The High Cost Of Academic Journals Limits Public Access To Research.
FTC goes after Bayer, other diet pill/vitamin companies
The FTC has penalized 4 diet pill and vitamin manufacturers, including the massive Bayer, a total of $25 million for making false or deceptive promises about the effects of their products. One company involved, Trimspa, used Anna Nicole Smith as its celebrity. The Pharma Marketing Blog has a good post called If FDA were as Powerful as FTC explaining the difference between the FTC's enforcement actions (which often include money penalties) and the FDA's (generally limited to "don't do this again" letters). From the blog:
FTC has powers far beyond those of mortal FDA -- it can impose fines, force the liquidation of assets, and put liens on property to collect settlement fees, all of which the FDA cannot do -- or has never done to my knowledge.
Two weeks ago, U.S. Senator Ron Wyden (D-OR) proposed an innovative solution to America's 46 million uninsured and counting health care crisis (from his website Stand Tall for America):
Start by making care more affordable. That means eliminating inefficiency, beginning with when a person signs up for coverage. Get citizens good quality outpatient health care so they don't go to hospital emergency rooms. Reward prevention-- health care, not sick care. Beef up the quality of care by reducing medical errors in our hospitals. The Healthy Americans Act provides a guarantee: health coverage for every American that is at least as good as Members of Congress receive and can never be taken away.
Here's more on the problem and solution from an LA Times column -- Going Universal -- from a few days ago by The American Prospect's Ezra Klein (here's his blog):
Surrounded by an unlikely array of union leaders and corporate chief executives, Sen. Ron Wyden (D-Ore.) has unveiled an inventive, comprehensive reform plan that would end the employer system forever. What businesses pay in employee premiums would be redirected to employee raises; insurers would offer their plans through state associations that would no longer allow price discrimination for reasons of health or job status; and everyone would have to buy in. Universal coverage would be achieved in under two years.
Joe Stiglitz on access to medicine and the prize fund
Nobel Prize-winning economist Joe Stiglitz has a column Scrooge and intellectual property rights in the British Medical Journal supporting the concept of a prize fund, instead of patent protection, to promote investment in prescription drug research. The idea has been promoted by CPTech and others and it is expected that U.S. Senator-elect Bernie Sanders (I-VT) will continue to support the idea, continuing efforts he started as a member of the House.
Here are links to a few interesting recent entries in the various consumer and public interest blogs I read:
Over at his Huffington Post blog, Jamie Love of CPTech has a well-researched and deeply-linked entry Merck, USTR ask Thailand to Reconsider Compulsory License on AIDS Drug documenting the U.S. government's continued efforts to block Thailand's efforts to provide access to low-cost AIDS drugs for its people. Jamie documents a history of US diplomatic power plays at the behest of the powerful pharmaceutical company Merck that seek to preserve Merck's intellectual property rights at the expense of access to medicine.
At his MSNBC Red Tape Chronicles blog entry Why Cell Phone Outage Reports Are Secret, reporter Bob Sullivan provides the FCC's reasons why consumers "have no idea how reliable their cell phone service will be when they buy a phone and sign a long-term contract." Bob points out that the FCC falls back on the lame, but ever-popular, "it would help the terrorists" defense to hide the real reason it doesn't want consumers to have this important shopping information so that they can compare cell phone plans better: FCC policy is to protect the regulated companies from having to admit their flaws publicly and suffer potential economic risk. The heck with the consumers stuck with the bad phone plans.
From the Hearusnow.org site of Consumers Union: Mark Cooper of the Consumer Federation of America, joined by media reform co-authors from Consumers Union and Free Press, has released a new book: The Case Against Media Consolidation. You can download it in pdf format for free under a Creative Commons license.
Over at Credit Slips, Elizabeth Warren comments on several recent reports on health care costs, including a JAMA study that finds that One In Five American families spent more than 10% of their annual income on health care in 2003.
In today's New York Times, Milt Freudenheim and Robert Pear do a very good job of exploring a variety of privacy issues raised by the ongoing switch to electronic health records, in their story Health Hazard: Computers Spilling Your History.
Would it be fair to lose a promotion because you'd been seeing a psychiatrist after a personal tragedy? Would it be fair to lose your job because a bean counter in Human Resources decided your health condition was too expensive for the firm's insurance policy? How about discrimination based on your DNA? And, with health records linked by Social Security Numbers, there's the threat of identity theft. Finally, voyeurs or persons seeking to do you harm could inappropriately use information from your health records, if those records are not well-enough protected. MORE:
The story describes the Paul Revere-like work of Dr. Deborah Peel, and of her Patient Privacy Rights coalition. Along with organizations from all parts of the political spectrum, U.S. PIRG health advocate Paul Brown has supported their important efforts to ensure that pending Congressional Health Information Technology (HIT) legislation includes provisions (1) allowing stronger state privacy laws to stand, even if a federal bill is enacted, (2) to allow consumers to keep their records out of databases without any retribution, and (3) to be notified of security breaches.
The story notes that corporate managers in charge of administering computerized health records systems are realizing that building in privacy at the outset is the only way to gain the trust of workers. It also cites two surveys where more than half of Americans expressed signifcant concern about health privacy:
The survey, conducted by Forrester Research, also found that 52 percent were "very concerned" or "somewhat concerned" that insurance claims information might be used by an employer to limit their job opportunities.
The Markle survey, to be published this week, will report even greater worry -- 56 percent were very concerned, 18 percent somewhat concerned -- about abuse by employers. But despite their worries, the Markle respondents were eager to reap the benefits of Internet technology -- for example, having easy access to their own health records.
Unfortunately, most of the health and technology industry lobbyists pushing the HIT bills are focused more on either the efficiencies or the massive anticipated revenue streams from selling new computers and databases than on agreeing to privacy protections, so due to their failure t agree to privacy protections, the legislation fortunately stalled in the last Congress, but it will be back.
Electronic recordkeeping of medical records has health benefits as well as privacy risks and costs, of course. The question is how to make sure that the less tangible privacy costs don't get lost in the shuffle. Passing legislation to accelerate the HIT conversion without building in privacy protection from the outset is the wrong way to go.
Personal privacy has always butted up against administrative efficiency, generally at the expense of privacy. Information originally collected for one narrow government or corporate purpose becomes available for many new purposes (use creep) when it is databased in a computer system. It also becomes more susceptible to misuse. These problems have been bad enough in a world where everyone's financial lives have become an open book; they'll only get worse if medical records aren't well-protected.
Hospital infections sicken 19k in Pennslvania in 2005
Over 19,000 Pennsylvanians got infections while at Pennsylvania hospitals in 2005 due to inadequate sanitary practices and lax infection control procedures, according to a first-of-its kind report mandated by PENNPIRG-backed legislation (fact sheet). The Pennsylvania Health Care Cost Containment Council (PHC4) report (PENNPIRG-Consumers Union news release) estimates that 2,400 patients lost their lives in Pennsylvania in 2005 after contracting infections at the hospital. ABC News story featuring PIRG's Beth McConnell. WTAE-4 (Pittsburgh) story featuring PIRG's Paul Brown.
Split decision in Oregon on consumer ballot drives
Oregon voters yesterday voted overwhelmingly (Oregon PIRG release) to expand a successful bulk purchasing program to lower the costs of prescription drugs, but unfortunately overwhelmingly defeated an important proposal to ban the use of credit scores in insurance-decision-making. In California, we lost statewide ballot measures to raise tobacco taxes and tax oil companies drilling for oil on California land and use the funds for clean energy development. CALPIRG will continue to push the oil measure in the legislature, since 45% of voters went for it. We won two CALPIRG-backed Sacramento County questions opposing corporate welfare for the Sacramento Kings NBA team. Previous blog with details.
I am participating Friday in an important international meeting sponsored by the TransAtlantic Consumers Dialogue at Harvard Law School. The meeting, A Round Table on Open Document Format (ODF), attempts to answer the following and other questions about the inter-operability of text, spreadsheet and other files.
What if a citizen attempted to download an historical government record, or even a required form to apply for a government benefit or service, and found that he or she couldn't open the document because he or she didn't own certain proprietary software, for example, Microsoft Word, necessary to view the government document?
What if a citizen owned an older copy of that software, but the new document wasn't backwards-compatible?
Should a citizen be forced to purchase (or as in the previous question, upgrade) a private software product to access his or her government?
Should government software and procurement policies require or promote the use of inter-operable Open Document Formats (ODF) to prevent these outcomes?
One reason that the meeting is in Massachusetts is that Governor Mitt Romney (R) and his administration are pioneers in ODF procurement. More resources here at CPTech.
Wal-Mart's recent limited action lowering the price of some prescription drugs in some stores in some markets to as little as $4 was a good first step for uninsured consumers. Wal-Mart's expansion of the program and its emulation by Target was also a positive but, again, limited step. These big stores use their bulk buying power to get good prices, which they can choose to pass along. Of course, it's also a good deal for Wal-Mart and Target-- it generates traffic into their stores.
But what if the drug you need isn't one of the 20% or so of the drugs Wal-Mart offers that's available at this low price?
Wouldn't it be better if any uninsured consumer could take advantage of a prescription drug buying plan that delivers huge discounts on a full range of generics and name-brand drugs, saving as much as 60 percent, and could purchase the drugs at any store or pharmacy? It could happen in Oregon, on Election Day. MORE.
It's the goal of Oregon's ballot Measure 44, which would expand to all of Oregon's 1 million uninsured the benefits of a successful state prescription drug buying pool program now available only to state agencies and low-income uninsured seniors. Here's a column by Laura Etherton of Oregon PIRG (OSPIRG) in in today's Oregonian newspaper. Excerpt:
The Oregon Prescription Drug Program started small, available only to some state agencies and low-income uninsured seniors. Now it makes both economic and health care sense to expand the program to everyone who lacks drug coverage. Thanks to the work of state Sen. Bill Morrisette and AARP, voters will have the opportunity to make that expansion a reality this November by approving Measure 44.
The measure will expand this proven program to the 1 million Oregonians lacking drug coverage. That will boost the program's buying power and deliver needed price relief. Because the program already pays for itself through the savings it negotiates, Measure 44 won't cost taxpayers a thing.
A broad coalition -- including Oregonians for Health Security, the Oregon Business Association, Service Employees International Union, the Oregon Medical Association, the Oregon Nurses Association, OSPIRG and others -- urges Oregonians to vote yes on Measure 44.
Guest Blog From Paul Brown, U.S. PIRG Consumer Advocate. More information on Rx drug costs here:
Victory on Drug Importation
Americans will soon be able to legally buy safe and low-cost prescription drugs from Canada thanks to the efforts of Senator David Vitter (R-LA) and others who added Rx drug reimportation language to the Homeland Security bill. The bill is expected to pass both houses and be sent to the president this weekend.
The bill allows Americans to buy up to a 90-day supply of Rx drugs from Canadian pharmacies. Unfortunately, internet and mail order sales, which would help the majority of Americans, would still be prohibited.
The Citizens' Health Care Working Group, a government commission, has released a major report promoting universal health care reforms, Health Care That Works for All Americans. Excerpt from the Recommendations: MORE:
1. Establish Public Policy that All Americans Have Affordable Health Care.
Americans should have a health care system in which everyone participates, regardless of their financial resources or health status, with benefits that are sufficiently comprehensive to provide access to appropriate, high-quality care without endangering individual or family financial security.
This public policy should be established immediately and implemented by 2012. 2. Guarantee Financial Protection Against Very High Health Care Costs. No one in America should be impoverished by health care costs. A national public or private program must be established to ensure:
Participation by all Americans
Protection against very high out-of-pocket medical costs for everyone
Financial assistance to pay for this coverage to families and individuals based on ability to pay.
The report's conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations. "Every organization has its share of dysfunctions, unhappy staff members and internal disputes," the report said. But panel members said that they were deeply concerned about the agency's "organizational health" and its ability to ensure the safety of the nation's drug supply.
The Washington Post quotes frequent FDA critic Senator Chuck Grassley (R-IA) criticizing the FDA's response to the study:
"The FDA appears to be focused on damage control rather than addressing its core problems. As a science-based agency, the FDA is remarkable for its lack of introspection, second-guessing, and failure to assess its own performance and capabilities in a systematic way."
We'll have more after our drug safety experts have analyzed the report in detail. It appears from news stories and the report summary that IOM supports many recommendations of PIRG, other consumer groups and Congressional reformers, but, according to the New York Times, IOM apparently does not support a PIRG-backed proposal, S. 930, by Sens. Grassley and Dodd (D-CT) to establish an independent center in FDA for post-market drug safety review. Today, the bulk of FDA's resources are frontloaded -- at the request of the powerful pharmaceutical lobby -- into efforts to approve new drugs. The IOM report cites the recent USPIRG/NJPIRG report by Abigail Caplovitz, Turning Medicine Into Snake Oil. Among our report's major findings: FDA policies to stop deceptive advertising are ineffective.
In the closing days of the legislative session, 3 more CALPIRG priority bills were sent to Governor Arnold Schwarzenegger, reports CALPIRG's Emily Clayton on her blog.
AB 2877 will create a state website where consumers can type in their zip code and the name of their prescription drug to get the lowest prices available for the drug in any given area.
AB 774 will guarantee fair hospital billing practices for the uninsured.
SB 840 will create a system of universal health insurance for California.
Last night the California legislature sent Governor Schwarzenegger AB 2911, sponsored by Assembly Member and Speaker Fabian Nunez. The bill is a priority proposal for CALPIRG that will establish the California Discount Prescription Drug Program to lower prescription drug costs for the uninsured by creating the largest prescription drug discount program on the nation. It's supported by a broad coalition, including AARP-California, the Mexican American Legal Defense and Education Fund, Consumers Union and SEIU. Here's CALPIRG advocate Emily Clayton's blog entry, including their news release.
This week, the John D. and Catherine T. MacArthur Foundation, well-known for its no-strings-attached individual "genius" grants to activists, academics, musicians, authors and others, announced that Knowledge Ecology International (formerly CPTech) was among the first winners of its new round of organizational genius grants. (Well, they're actually called MacArthur Awards for Creative and Effective Institutions.) It's a well-deserved award. MORE:
We've been fortunate over the years to work with the organization Consumer Project on Technology (CPTech) in campaigns designed to balance intellectual rights claims with the broader public interest. Among other goals, KEI/CPTech and the PIRGs and others seek to preserve access to knowledge and access to medicine. The group, which is in the process of changing its name to Knowledge Ecology International, is led by the indomitable Jamie Love.
CPTech has led many important and visionary fights, including its successful WTO battle against the powerful prescription drug lobby PhRMA and its sycophants in the U.S. State Department and European Commission, which made it easier to bring critical low-cost AIDS drugs and malarial and other necessary medicines to African and other less-developed nations. More recently, CPTech/KEI is leading the fight against a proposed broadcast treaty which invents then preposterously grants for 50 years a whole new set of property rights -- including rights to materials already in the public domain -- to webcasters (our previous blog on the proposed WIPO treaty).
For more than a decade, KEI led the successful campaign to lower prices of medicines essential for treating AIDS and other diseases through "compulsory licenses." It brought about numerous changes in international trade policy, working with nongovernmental organizations and academic partners to design a new trade framework and new financing mechanisms for medical research and development.
More recently, KEI has called on the World Intellectual Property Organization to take a more balanced approach between promoting intellectual property rights and serving the public interest. It seeks to slow or stop work on treaties that could restrict severely access to knowledge.
As the Washington Post story on the award notes, CPTEch/KEI is also working with U.S. Rep. Bernie Sanders on innovative proposed legislation, HR 417, that would change the way we reward inventors of new medicines to "drive down the price of drugs by changing how research and development are financed. The goal would be for development to be based on drugs' potential health benefits, not on their potential market value."
Doughnut holes and other drug industry shenanigans, too
The powerful prescription drug industry, which has long viewed itself as above the law, continues to make massive profits, but it is finally starting to feel heat from intensified scrutiny by policymakers and the press. Here's a roundup of recent issues, from senior citizens reaching the Medicare doughnut hole, to free lunches for doctors to ways drug companies pay off competitors to forget about competing. More:
Medicare Rx and its Doughnut Hole: Robert Pear over at the New York Times in a story today Medicare Beneficiaries Confused and Angry Over Gap in Drug Coverage, explains the problems faced by many senior citizens with moderate to severe health problems whose federal prescription drug benefits have hit the benefit gap known as the doughnut hole, where they must pay full price for their drugs, and pay the insurance premium for benefits, too (after your first $250-$2250 in drug purchases in a year has been subsidized, you must pay full price up to $3,600 (the hole) before benefits resume.) To be fair, this particular fiasco is more the result of the Bush Administration wanting to make sure it had enough money in the budget to lower taxes on the rich than the prescription drug firms' shenanigans, but their high prices were the reason it was even politically necessary.
Rx Influence Peddling: Over at the White Plains Journal-News (NY), there's a fine editorial today Truth In Medicine--Or Not? covering a range of distasteful drug industry practices and expressing disappointment with the once-mighty federal Food and Drug and Administration (FDA) and with supposedly independent medical journals that fail to disclose conflicts of interest by the authors of their articles. From the Journal-News:
Less obvious, but perhaps most corrosive, are the unholy alliances that titan pharmaceutical companies forge with doctors, hospital administrators, researchers and what is supposed to be the independent regulator protecting consumers' lives, the federal Food & Drug Administration. Meanwhile, the influence that drugmakers and their lobbyists exert on Albany and Washington lawmakers, and political parities, is so great, so pervasive that to question it is seen in such corners as the utmost in naivete.
The editorial also supports efforts by AARP, NYPIRG and others to enact reasonable reforms to what is known in the trade as drug detailing, but means in English: giving free gifts, free lunches, junkets to nice places, and other bric-a-brac to doctors as a form of influence-peddling. Here's a link to a CALPIRG report on detailing -- 'Tis Always the Season for Giving -- and here's a recent New York Times story Drug Makers Pay For Lunch as They Pitch.
Choking Off Lower-Priced Generics: We've been encouraged that state and federal consumer cops are stepping up their enforcement of the anti-trust and competition laws to prevent powerful prescription drug companies from slowing the introduction of lower-priced generic alternatives. Powerful prescription drug companies have long used every possible tool to extend their ability to gouge the American public. Their toolbox includes several wrenches used to manipulate the patent system and slow the introduction of lower-cost generic drugs. Among these has been the practice of making payments to generic companies not to compete. According to a story States Reject Deal On Plavix, in Blow To Bristol-Myers in Saturday's Wall Street Journal (paid subs. req.):
State attorneys general rejected a deal struck by Bristol-Myers Squibb Co. and Sanofi-Aventis SA to delay generic competition of their best-selling drug, signaling an increasing regulatory crackdown against such agreements. The decision is more bad news for the two drug makers, coming on the heels of news that the antitrust division of the Justice Department has launched a criminal investigation into their conduct in connection with the agreement...Deals between branded-drug companies and generic manufacturers intended to delay introduction of lower-cost generic pills have proliferated in the past few years, causing rising concern among U.S. regulators.
The Federal Trade Commission recently (20 July 06) offered detailed testimony on its legal, regulatory and policy responses to the problems, including that deceitful practice where brand name companies pay off generic companies not to compete. The FTC makes detailed recommendations to Congress to ensure better competition and to counter recent court decisions that have made it harder to prevent collusion.
CALPIRG, despite a recent committee defeat, continues to push legislation requiring disclosure of all drug company health studies (clinical trials), good and bad. It was introduced in response to the VIOXX tragedy, which was worsened by drug giant Merck's cover-up of its own negative health studies, and other drug safety tragedies like it. NYPIRG seeks passage of legislation requirng a low-cost prescription drug buying pool and also disclosure of drug company gifts to doctors. NJPIRG has a legislative Campaign For Safe Drugs. We have published a number of other reports describing ways to lower the costs of drugs, such as Paying the Price (July 2006) and, on drug safety and marketing, Turning Medicine Into Snake Oil (May 2006).
Well, so-called U.S. Senate Health Week lurched to a close with no bills passed when the well-intentioned but poison-pill-laden, preemptive and fatally-flawed Enzi (R-WY) bill (S. 1955) to stimulate small business health plans failed to get the 60 votes needed to end debate. Thanks to Senators Lincoln Chafee (R-RI) and Jim Jeffords (I-VT) for joining all Democrats except Mary Landrieu (D-LA) and Ben Nelson (D-NE) in voting NO on HR 1955. Majority Leader Frist (R-TN) himself virtually guaranteed this result when he brought the bill to the floor but then used one of the Senate's complicated procedural tricks known as filling the amendment tree to prevent any amendments from being considered, so any criticism from him is disingenous. Senator Harry Reid (D-NV), the minority leader, was widely quoted saying: "This is healthcare week. We haven't had healthcare minute." Earlier in the week, bills to limit the rights of medical malpractice victims were also defeated. Our previous blog with our S. 1955 opposition letter.
Last night so-called Senate Health Week got off to a stunning start as two Senator Frist-backed (R-TN) bills to weaken protections for victims of medical malpractice were crushed, as Dana Milbank reports in Take Two of These and Call Us Next Year in today's Washington Post. Next up, S 1955, Senator Enzi's (R-WY) proposal to expand health coverage affordability by exempting some plans from state laws requiring minimum coverage. Expanding health insurance coverage is a well-intentioned goal, especially when compared to Dr. Frist's proposals to cap the damages available to victims of drug company, hospital or doctor malpractice. But the Enzi approach is misguided. It will only precipitate a race to the bottom as our letter in opposition explains:
Twelve governors, 41 state Attorney Generals and dozens of state Insurance Commissioners oppose this legislation. We do have a health insurance problem in this country, but this bill is not the solution and may make things worse by negatively affecting the health care of 85 million Americans. Instead of supporting S. 1955, we urge you to support the Durbin-Lincoln Bill, S. 2510, which would allow small businesses to join purchasing pools to lower their insurance cost, but would still require that all health insurance plans meet state benefit and provider access protection laws.
Last week was the laudable national Cover the Uninsured Week, endorsed by a wide variety of organizations seeking to address the conundrum that the richest nation in the world, one that pays by far the most for health care, still has 46 million without health insurance.
Not to be outdone, this week, the U.S. Senate rolls out the falsely-named and self-proclaimed Senate Health Week, where all the bills with leadership support would make it harder for victims of medical malpractice or lack of health insurance to do better. All these bills would establish mediocre federal schemes and preempt stronger state protections. MORE:
Tonight, the Senate will vote on whether to go forward on S. 22-Ensign-R-NV and S. 23 -Santorum-R-PA. These guaranteed-to-fail-on-the-floor bills are part of a Majority leader Bill Frist (R-TN) campaign to make consumer lawyers look evil. The bills would cap pain-and-suffering awards available to victims of drug company, hospital and/or medical malpractice. S. 22 limits everyone's protection; S. 23 singles out pregnant women and their babies for less protection against malpractice. Our coalition letter. As it has previously, the Senate will reject these bills.
Tomorrow, after tonight's failed votes on S. 22 and S. 23, the Senate will turn to S. 1955, the Enzi proposal on expanding small business access to health care. That's a good idea, but the bill is the wrong approach. It will raise costs of health care, eliminate necessary specialized coverage for many Americans, and ultimately result in a race to the bottom where everyone ends up with sub-standard care. A better idea is Senator Durbin's proposal, which is expected to be offered as an amendment to Enzi.
The PIRGs released a major new report today, Turning Medicine Into Snake Oil, on how drug company advertising for Vioxx, Paxil and other drugs often contains false, deceptive and dangerous messaging to doctors and consumers. NJPIRG Law and Policy Center consumer advocate Abigail Caplovitz analyzed the last five years of FDA enforcement letters sent to drug companies to find that:
Prescription drug marketers are inundating doctors, and to a lesser extent, the public, with marketing that misrepresents risks, promotes unproven uses, and makes unsubstantiated claims...From 2001-2005, 85 companies received 170 notices from the FDA explaining that the marketing for 150 different drugs was false and/or misleading.
Click continue reading for more details:
Among the report's key findings:
Drug marketers make unsupported or misleading claims.
-Thirty-eight percent of messages to doctors and consumers made unsupported or misleading claims.
-Thirty-five percent misrepresented risks or side effects of taking the drugs.
-Twenty-two percent promoted unproven drug uses.
FDA policies to stop deceptive advertising are ineffective.
-About one-third of the drug marketers receiving FDA enforcement letters received more than one letter declaring their ads false or misleading.
-Many drug marketers received more than one letter addressing the same problem.
Deceptive marketing aimed at doctors.
-Physicians were inundated with 38 different types of dangerous and misleading marketing tactics.
"Doctors are targeted because they're the ones who write the prescriptions," said U.S. PIRG Consumer Advocate Paul Brown. "Drug companies know who they have to influence, if they want to jack up sales and profits."
Deceptive marketing aimed at consumers.
-Print ads, TV ads and website ads make up almost 80 percent of deceptive marketing aimed at consumers. These direct-to-consumer ads potentially mislead millions of people, far more than the marketing aimed solely at doctors.
Deceptive marketing includes clinical trials.
-Drug companies suppress unfavorable clinical trials.
-They use public relations firms to write favorable research reports and then list a doctor's name on the report as the "author."
-The FDA highlighted at least 82 times false or misleading advertising cited clinical trials.
"If we can't rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed," Caplovitz said. "Medicine, not marketing must drive clinical trial designs."
The report recommends that Congress:
-Pass The Food and Drug Administration Safety Act, Senate Bill 930, which requires the FDA to review prescription drug advertising materials before consumers see them.
-Require that clinical trials used to support advertising claims be approved by the FDA.
-Authorize the FDA to levy stiff fines against drug marketers who use deceptive tactics.
"The FDA's current enforcement isn't even a slap on the wrist," Brown said. "A slap on the wrist would be an improvement."
The report recommends that individual states:
-Pass laws to make it easier for consumer to sue drug marketers for deceptive advertising.
-Create a comprehensive, searchable database of clinical trials, which would make it harder for drug marketers to suppress or misrepresent data.
"States can protect consumers now from the dangers of deceptive drug marketing," Caplovitz said. "There's no need to wait for Congress or the FDA."
The report includes six case studies of deceptive marketing: Vioxx, OxyContin, Paxil, Accutane, Neurotin and Tindamax. The report's numbers are derived from FDA letters to drug marketers.
Our colleague Jamie Love of CPTech, one of the world's leading experts and activists on intellectual property rights, has a nice blog piece, Terrorism, Pfizer Style, where he explains how
I blogged last week on a 
Here's a fact you may not know: The fastest growing uninsured population in the U.S. is young adults--of the 6.6 million people that have joined the ranks of the uninsured since 2000, nearly half are 19-34 year-olds.
Our colleagues at Essential Action have a new e-newsletter, the Global Access to Medicines Bulletin. Click 
Over at the Prescription Access blog of our partners the Prescription Access Litigation project, check out the post: 
The 
Wal-Mart's recent limited action lowering the price of some prescription drugs in some stores in some markets to as little as $4 was a good first step for uninsured consumers. Wal-Mart's expansion of the program and its emulation by Target was also a positive but, again, limited step. These big stores use their bulk buying power to get good prices, which they can choose to pass along. Of course, it's also a good deal for Wal-Mart and Target-- it generates traffic into their stores. 
The prestigious Institute of Medicine has released a major new report: 
In the closing days of the legislative session, 3 more CALPIRG priority bills were sent to Governor Arnold Schwarzenegger, reports CALPIRG's Emily Clayton on her 
consumers.