More from Paris Accord II, the film and video workshop
The Paris Accord II conference linking creators of content with consumers continues with a workshop today on film, video and art. Here is a long-distance Flip video snap of media futurist Gerd Leonhard presenting. Other panelists listed here on the agenda. Previous blog on yesterday's action at the event. Participants twitter at #tacd. Excerpt from the working draft of the Paris Accord document regarding film, video and art:
1.It is vital to ensure that both content makers and consumers have unimpeded, but fair, access to communicate and engage in transactions with each other. Access to audiovisual content is essential to help ensure the public can readily obtain diverse sources of information, including cultural products.
2.The growing availability of a multiplatform digital distribution systems, such as the broadband Internet, Internet Protocol TV (IPTV), and mobile services, provides an important opportunity for both audiovisual content creators and consumers. For example, media makers can now sell content directly to consumers using broadband connections. Consumers also have the ability to view and acquire a diverse array of audiovisual content.
Update: This was a great panel, with a lot of spirited debate between the musicians who sample from others' work and those who don't. Hank Shocklee: "I was sampling before they made up the word. Many of these laws were written because of me." Various ideas were discussed to compensate musicians whose work is sampled by others, as well as to address numerous other problems in compensating musical creators. As the Paris Accord process goes forward, the group may be able to propose solutions.
The Paris Accord II conference (previous blog) linking the creative community's interests to those of consumers continues. The current panel is discussing a variety of issues, from Napster and successors to the rise of re-mixing and new distribution systems and rights agreements, and trying to figure out a model that works for musicians to make a living by convincing consumers not to illegally download. From left, musician-composer Jonatha Brooke, musician-composer Hank Shocklee (known for his work with Public Enemy), Fred van Lohmann of Electronic Frontier Foundation, music copyright expert and consultant Ann Chaitovitz, Edouard Barreiro of the consumer group UFC-Que Choisir, manager-producer Peter Jenner (Pink Floyd, The Clash) and musician-composer Pia Raug. Participants are twittering at #tacd.
TACD/Paris Accord II meeting between consumers and creative community
Today, Nicole Allen (pictured left), coordinator of the Student PIRG Maketextbooksaffordable.org campaign, and I are at the Institut national de l’histoire de l’art in Paris, where we are participating in an international conference of the PIRG-backed TransAtlantic Consumer Dialogue (tacd.org). The Paris Accord II is a followup to a 2006 event:
The Paris Accord is an ongoing effort to negotiate an agreement between creative communities and the public. Such an agreement would include recognition of (and suggestions for improving) (1) access to and (2) income for the knowledge goods produced by creative communities. Current copyright and patent systems on both sides of the Atlantic discourage innovation and prevent inventions and creations from entering the marketplace. A lack of dialogue between creators, rights holders, service providers and users continues to hamper development of legal methods of copyrighted content distribution.
Nicole's panel also included Vera Franz (at right) of the Open Society Institute (OSI), who presented on the growth of open access journals and repositories, as well as other experts on new scholarly publishing models. Full agenda. (Participants are tweeting at #tacd or #parisaccord.) The event features panelists including advocates, authors, musicians (including Hank Shocklee of Public Enemy), filmmakers, medical researchers and others. It is an effort to find common ground between the creative community and users of content, without the din created by participation of powerful copyright or patent holders and middlemen, most of whom seek restrictive copyright protections in national law and international treaties that harm democratic social discourse, hold back development of new medicines and sometimes even hold consumers criminally accountable for their "fair use" actions to use materials they have rightfully purchased. And, as Vera Franz pointed out, that while some of these powerful interests may characterize consumers as "pirates or communists, we are neither." The conference is one of a series of TACD events to build networks and communities to preserve access to knowledge and access to medicine and to ensure that these goals are achieved for both north and south countries globally.
In a release yesterday, U.S. PIRG Health Care Advocate Larry McNeely called the health insurance lobby's claims that reform would cost too much "futile" and cited instead reports that refute their self-serving claims: The report is flawed because, McNeely noted, it explicitly excludes many provisions in the bill that would bring down the cost of care, like delivery reforms, affordability tax credits, and increased competition in insurance exchanges. A recent report from U.S. PIRG came to a conclusion that stands in stark opposition to the health insurance industry-funded document. The Three Trillion Dollar Question identified $2.8 trillion in potential economic savings from robust health reform. In addition, the Commonwealth Fund and the non-partisan Congressional Budget Office (PDF) have concluded separately that health reform could generate real reductions in national health spending.
Brave New Films has a new Youtube video worth watching. From the promo:
Netting $2.5 billion in profits last year wasn't enough for WellPoint, the nation's largest insurance company. Now, WellPoint's affiliate, Anthem Blue Cross and Blue Shield, is suing the state of Maine for refusing to guarantee it a profit margin in the midst of a painful recession. As if Mainers didn't have enough to worry about just struggling to put food on the table, WellPoint is intent on forcing them to cough up 18.5% higher premiums on their insurance policies.
And if you cannot read the graphic, the video explains that its CEO Angela Braley makes nearly $10 million. I haven't checked, but I am sure that just a few years ago, its Maine affiliate Anthem Blue Cross/Blue Shield, was a non-profit that was then privatized to make it easier for Wellpoint to take the money and run.
A drug maker is using free speech claims in an attempt to invalidate prohibitions on off-label marketing to doctors. Currently, doctors can prescribe a drug for anything, but firms cannot pitch untested, unapproved uses to them. The incentive to do so, however, is there because a drug for a rare disease, with a limited market, makes a lot more money if sold for other more common diseases. Experts believe that a bad outcome could invalidate the entire scheme of FDA drug safety regulation. From today's New York Times story Botox Maker’s Suit Cites Free Speech by Natasha Singer:
“This is the broadest attack on the constitutionality of F.D.A. restrictions on speech brought by an individual drug company. It’s a precedent-setting case,” said Jeffrey N. Gibbs, a lawyer in Washington who specializes in food and drug law. “They are seeking relief which would invalidate all of the F.D.A. regulations which restrict the promotion of drugs.”
The firm appears to think that courts will eventually send this case up to what has been called the Supreme Court, Inc., which it hopes will rule that its commercial speech rights outweigh the rights of the government to regulate safety in the marketplace. Of course, while this is a big lift, it is not a complete sucker bet, because this is the same Supreme Court that is ready to rule that corporations are people and can make direct corporate contributions to political campaigns. The New York Times continues with the firm's argument:
“Allowing physicians to use drugs off-label, but at the same time prohibiting drug companies from proactively sharing relevant and truthful information with physicians regarding the risks and benefits and techniques for off-label uses does not serve the public health or patient care,” Douglas S. Ingram, the executive vice president of Allergan, said in a phone call with analysts Friday.
But the story then points out:
Off-label marketing is prohibited partly because a nonapproved use of a drug often lacks the kind of safety and efficacy data required for an approved use of a drug. “If you could get a drug approved for one narrow use and then market it for everything else, there would be no incentive or motivation for a company to prepare data to ensure that it meets the standard for safety and efficacy,” said Marc J. Scheineson, a lawyer specializing in food and drug regulation at Alston & Bird in Washington.
We might as well go back to the days of unregulated patent medicines and elixirs, laced with alcohol, cocaine, opium and even heroin, marketed by quacks and peddlers and grocers-- with labels that say that they cure everything. From a history:
Daffy's Elixir Salutis for "colic and griping," Dr. Bateman's Pectoral Drops, and John Hooper's Female Pills were some of the first English patent medicines to arrive in North America with the first settlers. The medicines were sold by postmasters, goldsmiths, grocers, tailors and other local merchants. By the mid-19th century the manufacture of these products had become a major industry in America. Generally high in alcoholic content, the remedies were popular with people who found alcohol therapeutic. Many concoctions were fortified with morphine, opium, or cocaine. Sadly, some of these products were labeled for infants and children. Parents seeking relief for their babies from colic often gave these opiate remedies with fatal results. The remedies claimed to cure or prevent nearly every ailment known to man, including venereal diseases, tuberculosis, indigestion or dyspepsia, arthritis, baldness, and even cancer. "Female complaints" were often the target of such remedies, offering hope for women to find relief from monthly discomforts. Bust developers and manhood restorers were also promoted.
In case you missed the hullabaloo this week, today's Washington Post story Firm Aggressively Campaigned for Device reprises the sordid ReGen story-- here's a summary for those who missed it: two former high FDA and hill staffers go to work for medical device firm, facilitate massive campaign contributions to former Senate boss Bob Menendez (D-NJ) and three of his NJ delegation colleagues, use influence and access lubricated by said donations to meet with former FDA chief Andy Eschenbach, who rolls over and approves apparently worthless and possibly side-effect-riddled knee repair device previously rejected three times by his expert scientists. Post story says FDA report finds "ReGen executives had unusual access to von Eschenbach and that approval came after he met several times with members of the New Jersey congressional delegation."
Well, I don't actually know how unusual it is. You could probably change the names and agencies and decisions and find similar stories every day in Washington. Campaign money is corrosive and the revolving door hits taxpayers and consumers more than it hits the suits marching through it on their way between lucrative lobbying and government posts. I actually find the most interesting part of the story to be this coda:
Von Eschenbach, who now helps companies navigate FDA regulation at a consulting firm created last year by his former FDA chief of staff, was traveling Friday and unable to respond to questions, his assistant said.
I wonder if his firm makes campaign contributions or has unusual access?
Senator Ted Kennedy will be deservedly remembered for all the important legislation he shepherded through the Congress to help the least among us, and to help all of us against powerful interests, as well as for the passionate way he went about this work. At PIRG, we were fortunate to work with him on numerous victorious campaigns, including the recent improvements to student loan laws. I will always remember the privilege of working with him on an important, but losing, campaign against the draconian bankruptcy bill. As I blogged last year when the Senator's illness was first disclosed, he'd taken over the fight after the tragic death of Senator Paul Wellstone. Here's more on the relationship of that fight to the current fight for health care reform:
In the final bankruptcy battle on the Senate floor in 2005, Senator Kennedy unsuccessfully offered two important amendments to provide protection to families whose bankruptcies were brought on by illness exacerbated by crushing medical debt. You can read some of his powerful arguments starting on this pdf Congressional Record page and clicking "next page." Excerpt:
[Senator Kennedy on the floor:] The proponents of the bankruptcy bill have said the goal of the bill is to force those individuals who run up bills irresponsibly to take greater personal responsibility. [...] Nothing could be further from the truth for the thousands of individuals who are forced into bankruptcy to deal with the debt they were forced to take on to cope with serious medical expenses and the loss of income when they are unable to work due to serious illness or injury.
Continued after jump:
We had testimony from Professor Elizabeth Warren of the Harvard Law School last week making clear that more than half of those filings for bankruptcy have been forced to do so at least in part due to medical problems and their aftermath. [...] Those who go to bankruptcy court because of cancer or diabetes and heart attacks have not been irresponsible. Those who file for bankruptcy to deal with medical debts incurred when a child was born early with severe complications or an elderly parent needing costly prescription drugs or placement in a nursing home are not irresponsible. [...] We see health care coverage lost for these families who have paid in for 20 or 30 years. WorldCom closed down, Polaroid closed down, Enron closed down,
their health benefits are cut off, they get cancer, the bills run up, and what does this bill do? It puts them into indentured servitude to the credit card
companies. We call that fairness? That may be
the priority of some in this body, but it is not mine. Who do we in this body represent?[...] That is what we are about in the Senate? We have the problems of unemployment, the escalating costs of prescription
drugs, 8 million of our fellow citizens unemployed, school tuition going through the roof, and we are
talking about an additional $5 billion for the most profitable industry in America. Hello. Hello. That is what we are debating here. It is extraordinary. [...] I am tired, when one person tries to extend the same kind of health care we [in Congress] have to people out there, of people on the other side who say: Well, we are not going to support you. The problem is the health care problem, and we ought to deal with that. This is a bankruptcy issue. Come on. Come on. They oppose us when we try to pass health care legislation, and then they oppose us when we try to deal with the health care problems that are going to be impacted by the bankruptcy bill. It does not work that way.
It is time for Congress to reject the demands of Big Pharma, Big Medicine and the health insurance lobby and enact passage of what will certainly be called the Senator Edward M. Kennedy Health Care Reform Bill of 2009.
The reality is that the public option will be well-positioned to implement the type of smart cost controls that the private insurers should have adopted long ago. It could create incentives for primary care, prevention and wellness; pay doctors for good health outcomes, not just the number of tests run and procedures performed; create incentives for utilizing patient-centered research on which drugs and treatments work best; and ignore the hyperbolic sales pitches of drug companies. Once a public health insurance plan begins to implement these programs and realize true cost savings, private insurers will have to follow.
The Pop Tort blog has a nice entry following up on several recent New York Times stories about how doctors fail to disclose that they get paid by drug companies for signing their names to medical journal "research" articles that are actually written by some medical writing company ghostwriters who are also being paid by the drug manufacturer. Oh, it appears that the articles favorably slant against risks caused by the drug company's product.
New book dismisses arrogant music industry middlemen
I haven't read the book, but based on the review by Dana Jennings in the New York Times, I think I'd like it! Ripped: How the Wired Generation Revolutionized Music is authored by Greg Kot. Excerpt from the review:
Still, the most fascinating part of the book is its retelling of how the big music companies committed capitalist suicide. The executives couldn’t get their analog heads around the digital future. If industry leaders had always followed their mistrust of technology, we’d still be listening to music on 78-r.p.m. shellac, or maybe even wax cylinders. “Ripped” is another case study in American industrial arrogance, an account of companies that couldn’t (or wouldn’t) learn agility. Instead of adapting to the new reality, they started calling their customers thieves.
This fall, the PIRG-backed TransAtlantic Consumer Dialogue will hold its second Paris Accord workshop. One of the Accord's key goals is to bring music creators and music consumers closer together, bypassing the "commercial entities" that unfairly divide us. Excerpt:
1. Authors, composers and performers of musical works, and consumers agree that we have common interests and new opportunities to collaborate. Enormous differences in bargaining power currently lead to unfair outcomes between creative individuals users and the commercial entities that sell culture and knowledge goods.
The story And You Thought a Prescription Was Private by Milt Freudenheim in today's New York Times will probably shock a lot of people. But the fact is, despite major improvements made by the American Recovery and Reinvestment Act (ARRA) of 2009 to the Health Insurance Portability and Accountability Act (HIPAA) of 1996, neither your prescription privacy nor your medical privacy more broadly are yet fully guaranteed. When the ARRA changes take full effect, you'll be better, but not fully, protected. The story explains how "de-identified" information can be "re-identified;" how hackers and voyeurs can gain access to your records, and also some of the "therapeutic" and other exceptions to supposed limits on marketing. It also explains important efforts by states to rein in drug marketing and protect privacy.
U.S. PIRG's Larry McNeely speaks in support of health care reform in front of the U.S. Capitol, joined by our 8-foot tall spokesconsumer Health Care Harry and friends. Photo by Brian Walker of our staff. More at our health care pages.
Our giant spokesconsumer, Health Care Harry (an eight-foot tall interactive version of the Operation game’s “Cavity Sam”), will appear at the House Triangle outside the U.S. Capitol for a news conference Tuesday, 4 Aug at 10am in support of reform. He'll be joined by a doctor and our U.S. PIRG Health Care advocate, Larry McNeely. Harry's been on tour in Maine, with one of our senior consumer advocates, MASSPIRG's Deirdre Cummings. Watch them on WCSH6 (Portland) and FoxMaine and WGME13 Portland. More at PIRG's health care pages.
He's being choked by paperwork and red tape, drug companies are trying to pull the wool over his eyes and give him pills he doesn’t need. And if he isn’t careful, insurers might just pull the rug out from under him by dropping his coverage, or slam a door in his face because he’s got a pre-existing condition!
Our efforts revealed that small businesses who do not currently offer coverage would overwhelmingly like to, but are stymied by high costs, complications and red tape. [...] * 78% of small businesses who do not offer coverage would like to do so. * 80% of those owners who would like to offer coverage cite cost as a barrier
PIRG: Public plan option needed for real health care reform
Just as the banks that helped destroy our financial system are fiercely opposing transformative financial reform, the health insurance lobby that has failed to develop a business model that will cover all Americans fiercely opposes the reasonable, but transformative, reform of offering a public plan option. Watch a video with U.S. PIRG's Larry McNeely at U.S. PIRG's Health Care pages. Read a column by Florida PIRG's Brad Ashwell Choice: Public Health-Care Option in the Lakeland, Florida Ledger newspaper. Excerpt after jump:
The reality is that the public option will be well positioned to implement the type of smart cost controls that the private insurers should have adopted long ago, but few of them did. It could create incentives for primary care, prevention and wellness; pay doctors for good health outcomes, not just the number of tests run and procedures performed; create incentives for utilizing patient centered research on which drugs and treatments work best; and ignore the hyperbolic sales pitches of drug company salesmen, instead opting for what is proven to work.
Jamie Love, director of Knowledge Ecology International, perhaps the key group working anywhere to promote access to medicine by eliminating unfair patent and trade rules that allow brand name drug companies to block low-cost competitors, has a new HuffPo blog entry on the fight over generic competition to biologic drugs. Excerpt from Key democrats back BIO industry against consumers to delay generic medicines (biosimilars):
Unlike for pharmaceutical drugs, there is no easy way to get FDA approval for a generic biologic product (called biosimilars). Congress is considering an FDA reform to fix this. But the reform is being derailed by an effort by BIO, the trade association for the biotechnology industry, to create a long period before generics can enter the market. BIO is asking Congress to approve 12 to 14.5 year legal monopoly on a biologic product, that has nothing to do with the patent status of the product.
This week, U.S. PIRG's Larry McNeely testified in favor of the Waxman proposal also backed by Love and KEI. But, the Senate HELP committee has taken the BIO position in its bill just voted on by committee.
Yesterday U.S. PIRG Health Care Advocate Larry McNeely testified at a House Judiciary subcommittee hearing on Biologics and Biosimilars: Balancing Incentives for Innovation. Like their predecessor brand name chemical drug manufacturers, biologic drug companies are arguing that they are special and deserve special protection from generic competition. We disagree. From our news release: “We need markets that drive innovation, not those that reward monopoly,” McNeely said before the House Judiciary Committee’s Sub-Committee on Courts and Competition on Tuesday. The generics industry and public interest advocates support Rep. Henry Waxman’s (D-CA) “Access to Life Saving Medicine Act,” while the pharmaceutical and biotechnology lobbies have lined up behind a House alternative offered by Rep. Anna Eshoo (D-CA).
For the majority of medical conditions, no studies exist to help doctors – and their patients – determine the most effective course of treatment among all the available option. “The information just isn’t out there. Should a patient use a drug, undergo surgery, change her diet? With technological advancement as rapid as it is, the distance between what we know and what we need to know grows daily. We can get the answers, but we need to devote the resources to research them,” explained Jeff Bernstein, Policy Analyst for U.S. PIRG and author of the new report.
"In rich countries, new sectors of society are succumbing to poverty and new forms of poverty are emerging. In poorer areas some groups enjoy a sort of “superdevelopment” of a wasteful and consumerist kind which forms an unacceptable contrast with the ongoing situations of dehumanizing deprivation."
Importantly, the Pope criticizes patent policies that benefit the powerful prescription drug industry at the expense of affordable health care:
On the part of rich countries there is excessive zeal for protecting knowledge through an unduly rigid assertion of the right to intellectual property, especially in the field of health care.
As noted in my previous blog entry, the US DOJ will be investigating competition in the drug industry, expanding efforts long underway by the new US FTC chairman Jon Leibowitz, who began cracking down on "pay-to-delay" generics deals as a commissioner. On Capitol Hill, big PHhRMA, comprised of prescription drug companies long opposed to any competition or safety regulation that they don't approve of, has been joined in recent years by a new player. The emerging biotechnology superpower known as BIO -- whose members develop drugs through gene manipulation and cloning, although it is hard to find that simple explanation on their website -- is seeking extraordinary patent protection expansion as a part of the health care reform debate. Washington Post story on the Encyclical Letter: Pope Criticizes World Economic System, Urges Social Responsibility
TACD issues paper on enforcement of copyright/patent laws
As the U.S. and European Union governments, acting at the behest of powerful drug companies and copyright holders (film, music, book publishers) continue to lead closed-door negotiations on an outrageous, secretive and sweeping Anti-Counterfeiting Trade Agreement (ACTA), the PIRG-backed TransAtlantic Consumer dialogue (TACD.org) has issued a new Resolution on the enforcement of copyright, trademarks, patents and other intellectual property rights. Here is a TACD blog entry with more background on why. ACTA statement from Knowledge Ecology International (KEI). Release from U.S. PIRG and others (2008) demanding that ACTA negotiations be made public. IP Justice ACTA page.
Basically, the rightsholders are using the threats of "counterfeiting" and "piracy" to convince the governments to enact overly-broad restrictions through a treaty that they could never enact in the light of day in a legislature. Drug companies will use its provisions to block legal provision of low-cost drugs to the poor. As IP Justice points out, it could also change the Internet and stifle free expression:
ACTA places an emphasis on restricting the free flow of information on the Internet. It will require Internet Service Providers (ISPs) to police and control their systems for infringing content and require ISPs to turn-in their customers to law enforcement for prosecution of intellectual property violations. It threatens to require ISPs to block access to online information or delete their customers’ websites at the request of Hollywood entertainment companies and without any due process of law. The new IPR enforcement tools created by ACTA will make it easy to stifle online criticism of companies or products that are trademarked or copyrighted in violation of free expression.
In case you missed it, reporter Walecia Konrad had a story Medical Problems Could Include Identity Theft in the New York Times Saturday. The story featured Pam Dixon of the World Privacy Forum, who has done groundbreaking work (WPF medical theft id page) on the problem affecting over 250,000 Americans each year. From the Times:
When people are not aware their medical identities have been stolen, insurance companies may simply continue to pay the fraudulent claims without the victim’s knowledge. The person might learn of the fraud only when trying to make a legitimate claim, and the insurance company informs them they have reached their lifetime cap on benefits.
The flavor of the week for health care reform bashing appears to be doctors saying no -- with the American Medical Association in high dudgeon against almost any form of public competition. Meanwhile, U.S. PIRG Health Care Reform Advocate Larry McNeely has released an analysis of reform's potential impact on jobs. Putting America Back to Work, finds that proposals to tame health care costs could allow the creation of 2.5 million jobs over a five year period without inflationary effects, and yield stronger economic growth over the long term.
As legislation to revamp the nation's health care system moves forward, expect doctors, hospitals and big insurance companies to renew their efforts to make it harder to sue them when they make mistakes and to cap possible damage awards if a consumer actually wins justice. Yet, a new study by NYPIRG and the Center for Medical Consumers and endorsed by other leading groups questions the core claims these interests make. The new report, Contraindication, uses government data to show that consumer claims in medical malpractice lawsuits haven't caused the increase in medical malpractice insurance premiums nor driven doctors from the state, as doctor groups routinely allege. See the New York Times:
The New York Public Interest Research Group reviewed 15 years of federal data on medical malpractice payments and concluded that the amount of money paid for malpractice claims in New York has actually fallen in recent years, and that the number of overall claims has remained “remarkably stable.”
Consumer advocates are urging state lawmakers to allow victims and families to sue within 30 months after a medical error is discovered, instead of 30 months after the error is made, saying it is a particular issue with cancer cases and pathology reports. Current law provides doctors an incentive to hide their mistakes from patients, said Blair Horner of the Public Interest Research Group.
Also, see the Associated Press. The government data used by NYPIRG come from the National Practitioner Data Bank (NPDB). The NPDB’s Public Use Data File is the only publicly-available, comprehensive malpractice database in the nation. That database was established by law and has helped improve transparency in the health care marketplace. Its passage was preceded by successful state efforts led by NYPIRG, MASSPIRG and other leading reform organizations.
The total premium cost for employer-sponsored family health insurance has doubled in less than ten years, and may double again by 2016. In the face of high-cost premiums, both large employers and small businesses face tough choices: shoulder greater costs and potentially harm their competitiveness, pass on large increases on to employees who aren’t equipped to pay them, or reduce coverage.
Continued after the jump.
[...] Americans might accept these rising costs if their health care dollars were purchasing quality care on which they could depend. Instead, today’s health care system is undermining family physicians’ and other primary care providers’ ability to provide quality, personalized care to American families. [...] Over the first few months of 2009, these twin crises of cost and quality have helped generate an unprecedented breadth of support for reform. [...] This policy primer is intended to help meet that challenge. It examines seven factors which have led to the interrelated crises in cost and quality, and prescribes specific policy remedies to tame costs and restore health professionals’ ability to provide the care on which American families rely.
A new report says a state Web site designed to help consumers shop around for the least expensive medication offers inconsistent pricing information, with wild cost differences on the same drugs in different pharmacies.
Pfizer in settlement over deaths of Nigerian children
The drug giant Pfizer is reported (Washington Post) to have reached a settlement with the Nigerian government over what had been a $9 billion criminal indictment due to the deaths of at least 11 children and injuries to many others in an allegedly illegal drug trial in 1996. The company tested the drug Trovan during a meningitis epidemic. If reports of a $75 million settlement (presumably with criminal claims dropped) are true, it appears the drug giant got off cheap--kids' lives, no matter where they live, are worth more that. Also, such a small settlement may not deter other alleged corporate wrongdoing. It is unclear what effect the settlement will have on other civil cases. From the Washington Post:
Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.
The Le Carre book (and movie) The Constant Gardener are said by some to have been based on the tragedy.
Today's [New York] Times includes Online Age Quiz is a Window for Drug Makers, about a web site, RealAge, which tells you your "biological age" if you answer some 150 questions and offers suggestions for reducing that age. Sounds great. But, the article explains, the information collected is then used to identify patients who might be candidates for medications, and the company sends these patients emails sponsored by drug companies that sell the medications.
While the Supreme Court rejected preemption (6-3) of state law injury claims in a prescription drug labeling case yesterday (previous blog), the Roberts court, in particular, has generally been pro-corporate in other cases. In the last term, for example, it upheld preemption (8-1) in a medical device case known as Medtronic (previous blog). Leading members of Congress, led by Reps. Frank Pallone (D-NJ) and Henry Waxman (D-CA), yesterday introduced legislation, the Medical Device Safety Act of 2009, to overturn the Supreme Court's Medtronic ruling. Unless the bill becomes law, the Medtronic decision will lead to more unsafe products being embedded into people's bodies while preventing their ability to obtain compensation if harmed. From Waxman and Pallone's release:
The Court's decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings. It also removed one of the industry's most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians. The Medical Device Safety Act of 2009 protects patients from dangerous and defective devices by correcting the Court's flawed interpretation of the MDA. The legislation explicitly clarifies that state product liability lawsuits are preserved.
We've joined 15 other leading U.S. and international consumer and access-to-medicine advocacy groups, including Consumers Union, Knowledge Ecology International, Third World Network and Oxfam -- in a letter to Margaret Chan, head of the World Health Organization, criticizing recent seizures by Dutch officials of generic medicines made, in one case, in India and intended for use in Brazil, Colombia and Peru, after trans-shipping through the Netherlands. Copies of the letter were sent to Dr. Chan's counterpart director-generals at the World Trade Organization, World Intellectual Property Organization and the World Customs Organization. While the letter says it more diplomatically, the gist is this: we allege that the Dutch, acting on behalf of powerful European brand name drug companies, are subverting international laws and treaties to block access to legally-licensed (in the countries of both origin and destination) low-cost generic medicines intended for the poor.
new PIRG Report - Without Reform, Health Costs Will Double
U.S. PIRG Health Care Advocate Larry McNeely today released Health Care In Crisis, a new report that shows that without reform, health care costs will double by 2016. From the release: The report spotlights three important categories of wasteful health spending (all addressed by the Obama recovery passage under urgent Hill consideration):
$299 billion each year was spent on inappropriate, ineffective and uncoordinated care which can actually cause harm to patients.
An estimated $79 billion in costly red tape is generated created by bloated insurance company bureaucracy.
Pharmaceutical manufacturers spend over $11.5 billion on marketing of prescription drugs.
Corporate Crime Blotter: Rx here and foreign bribery there
From today's Wall Street Journal (pd subs. req'd) "Halliburton Co. said it has agreed to pay $559 million to the U.S. to settle charges that one of its former units bribed Nigerian officials during the construction of a gas plant." More from the Washington Post.
From WSJ: "Pfizer Takes $2.3 Billion Charge Linked to Bextra Probe: If you’re going to take a $2.3 billion earnings hit over government investigations, you might as well announce it the same day everybody’s more interested in your $68 billion deal." More from Philly.com.
MASSPIRG testifies on state drug company gift ban regulations
MASSPIRG testified this month that proposed regulations implementing an important new state law limiting drug company gifts to doctors and requiring disclosure of payments to doctors:
"do not adequately protect Massachusetts consumers.[...] The proposed regulations do not provide sufficient relief from the distortions caused by industry marketing practices that continue to drive up health care costs in Massachusetts and across the country."
Speaking today on innovation as a substitute for patents and copyrights
Today, along with my colleague Nicole Allen, who coordinates our maketextbooksaffordable.org campaign, I am speaking today at a TransAtlantic Consumer Dialogue (TACD.org) conference called Patents, Copyrights and Knowledge Governance: The Next Four Years. It's on ways to spur innovation while making the copyright and patent system fairer. As Nobel Laureate Joe Stiglitz told conferees yesterday, there are a variety of alternatives to the current system, which not only enriches monopolists, but creates both static and dynamic inefficiencies in the market that delay or halt the spread of new ideas and products. My workshop is on the use of prizes (you may have heard of the X-Prize) to encourage innovation. Last year, Senator Bernie Sanders (I-VT) introduced legislation to establish a medical innovation prize. We also believe prizes could spur the development of open source educational resources. More on prizes from KEI. My previous blog.
NY Times backs consumer groups' call for White House consumer czar
In today's editorial A Voice for the Consumer, the New York Times backs the recent call by U.S. PIRG, the Consumers Union, the Consumer Federation of America and other leading groups to restore the long dormant White House Office of Consumer Affairs. From the NYT:
The time has come to give the American consumer a much stronger voice in Washington. President-elect Barack Obama has already named what amounts to an energy and environmental czar in the White House, and America’s beleaguered consumers deserve no less.[...] Presidents Johnson and Carter both recognized the need for a strong person to do that job. Both chose Esther Peterson, who during about eight years in office pushed for then-radical ideas like nutritional labeling on food and truth in advertising. As the Reagan anti-government era began, the consumer protection job steadily lost clout until it was shuttered in the late 1990s.
Consumers Union's and the AFL-CIO's Esther Peterson pages. In recent columns, David Lazarus of the Los Angeles Times (syndicated, here it is in the Allentown (PA) Morning Call), Sheryl Harris of the Cleveland Plain Dealer and James Love of the Huffington Post have echoed many of our concerns and described some of our other goals. Chief among these is restoration of the authority, leadership and resources of the many federal consumer agencies that have done such a dubious job over the past eight years. Here is our full platform:
Read the details here:
1. Restore the United States Office of Consumer Affairs; Put a Consumer “Czar” In The White House.
2. Rein in Wall Street Excesses, Protect Consumers from Abusive and Predatory Lending.
3. Protect Consumers from Price-Gouging in Oil, Gas and Electricity Markets, and Take Steps To Provide Households With Access to Alternative Energy and Efficiency.
4. Improve Consumer Access to Justice By Reinstating Legal Rights.
5. Guarantee Safe, High Quality, Affordable Healthcare for Everyone.
6. Ensure our Food and Products are Safe.
In today's New York Times Magazine, Gardiner Harris explains in a detailed story that the once gold-standard U.S. FDA has a growing "Safety Gap". He argues that the FDA is under-funded, that it hasn't kept up with the globalization of commerce, and that it cannot protect us from dangerous products, especially those from China:
But are the Chinese factories safe? Who knows? [...] China has in recent years exported poisonous toothpaste, deadly dog food, toys made with lead paint and tainted fish. In one infamous example this spring, Chinese manufacturers substituted a cheap fake for the dried pig intestines used to make the drug heparin, which is given to dialysis and surgery patients to prevent blood clotting. [...] The F.D.A. regulates more than $1 trillion worth of consumer goods, which amounts to about 25 cents of every consumer dollar spent in this country. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements.[...] Even the F.D.A.’s staunchest defenders now acknowledge that something is terribly wrong.
He points out that it is not just money, it is antiquated computers, a lack of port and foreign inspectors and more. What's worse, many U.S. and other major drug manufacturers have put their faith in Chinese ingredients, increasing the load on the FDA. Now that Congress has fixed the CPSC (and we and others are vigilantly watching implementation and funding for the new Consumer Product Safety Commission Improvement Act) it is past time for vigorous oversight and improvement of the FDA. Meanwhile, to make matters much, much worse, the agency's mid-level professionals and scientists have suffered for years from a leadership full of drug and food industry insiders and political hacks bent on further deregulation and preemption. Tomorrow, the Supreme Court takes up a critical case concerning whether FDA warning label rules preempt state safety laws.
In 2002, Angela Crespo, then Neurontin's senior marketing manager, emailed an outside firm that was contracted to write up the study's results: "We are not interested at all in having this paper published because it is negative!!" Pfizer declined to make the three employees in the emails available for interviews.
The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.
The story goes on to point out that all the PhRMA kids were doing it--
Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors. [...] Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin...
Meanwhile, the Times separately reports in Child Warning Added to Cold Remedies that drug companies have begrudgingly agreed to warn that the remedies shouldn't be used by children under 4:
Despite the products’ extraordinary popularity, every study performed in recent years shows that they have no therapeutic effect beyond sedation, and a growing number of reports have concluded that they can be dangerous.
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 the massive pharmaceutical company Pfizer has sued a Filipino regulator personally, and taken other actions, apparently with support from the U.S> government, to block extremely modest efforts to lower the costs of the profitable hypertension drug known in the U.S. as Norvasc. More.
In the Philippines, Pfizer charges from $.88 to $1.46 per day for Norvasc (more for the larger dose). In 2004, the average per capita income in the Philippines was $3.20 per day. Eighty percent of the population lives on less than $2 per day. Pfizer knows this. They have calculated that they can make greater profits selling Norvasc at a high price to a small number of the wealthiest Filipinos (less than 5 percent of the population can afford the drug), than a larger number of people with lower incomes.
While Congress largely ignores the Vioxx and other drug safety scandals skipping across the front pages and endangering Americans' health, the states are quietly moving forward to protect citizens from unsafe drugs. Here's a blog comment by CALPIRG consumer advocate Emily Clayton on passage by a state Senate committee of S. 1683, the Pharmaceutical Drug Right-to-Know Act by state Senator Jack Scott, (and here's a CALPIRG press release on committee passage. The bill would require drug companies to release the results of all their health studies for every drug sold in California. U.S. PIRG's pages supporting S. 930, a proposal by Senators Chuck Grassley (R-IL) and Chris Dodd (D-CT) to improve FDA's drug safety. It's mired in typical Congressional gridlock exacerbated by massive drug company campaign contributions and obfuscation and confusion from their phalanx of lobbyists. California's excellent proposal is a perfect example of why states should not be preempted from protecting consumer pocketbooks and their health and safety. If the states don't lead, who will?
The April issue of PIRG's new newsletter, Preemption Alert, is available. Excerpts from the highlights: Protecting America's Food Supply: On March 2, over the objections of 39 Attorneys General, the House passed the National Uniformity for Food Act, which preempts at least 200 state food safety laws. Securing Chemical Plants: In a March 21 speech to the American Chemistry Council, Homeland Security Secretary Michael Chertoff signaled his support for weak federal safety standards for chemical plants and federal preemption of stronger state standards. Protecting Americans' Privacy: On March 30, the Senate Commerce Committee marked up a weak bill to protect consumers from those who seek to fraudulently access their phone records. This bill broadly preempts stronger state privacy laws or regulations as well as any laws imposing liability on companies for failing to protect consumer privacy. Providing Quality and Affordable Health Care: On March 15, the Senate Health, Education, Labor and Pensions Committee passed a bill allowing insurance companies or HMOs to circumvent state patient rights laws.
Several attendees have posted detailed blogs on last week's Politics and Idealogy of Intellectual Property Conference in Brussels. More.
I participated (see immediate previous blog) in the event sponsored by the PIRG-backed TACD. Here's Ian Brown's post over at Blogzilla, where he comments on participant Bruce Lehman's revelation that the TRIPs (Trade Related Aspects of Intellectual property) agreement he'd negotiated as a senior Clinton official was a "mistake" for the U.S. Meanwhile, Johanna Gibson, JD, PhD, who runs the Patenting Lives Project of the Queen Mary Intellectual Property Research Institute, University of London has posted her own summary where she says that the event
"demonstrated the ever increasing importance of civil society in international norm setting, and the undeniable importance of "consumers" (indeed, producers in their own right) as stakeholders in international intellectual property law debate."
I'm participating Monday and Tuesday at a conference on The Politics and Idealogy of Intellectual Property in Brussels, Belgium. The conference speakers and issues are worldwide in scope; it is sponsored by the PIRG-backed Trans Atlantic Consumer Dialogue (TACD): From the brochure:
In recent years, intellectual property policy issues have gained higher profiles in Europe and the United States, as debates over patenting of software and business methods, copyright term extensions, the public domain nature of the Human Genome Project, access to medicine, peer-to-peer file-sharing networks, and other hot button issues have attracted a wide public audience...In particular, the meeting will examine how the struggles over the control and ownership of the new knowledge economy relates to our concepts of ideology, in party political positions platforms and political rhetoric.
For more information on PIRG's and others' work on these important matters, see our Access to Medicine and Access to Knowledge blog archives. I won't be blogging "live", but I'll let you know who is.
A Gannett story running in The Tennessean today, Hastert, Frist said to rig bill for drug firms, quotes both Republican and Democratic Representatives and Senators who are sharply critical of a PIRG-opposed stealth power play by Senate Majority Leader Frist (R-TN) and House Speaker Hastert (R-IL) to gain sweeping lawsuit immunity for vaccines and other drugs used in pandemics. In late December, the provision was added without debate and without consent of conferees (and according to the story, possibly through deception of conferees) to a defense spending bill that has become law (our previous blog here). From The Tennessean:
About 10 or 10:30 p.m., Democratic staff members were handed the language and told it was now in the bill, [David] Obey [D-WIS] said. He took to the House floor in a rage. He called Frist and Hastert "a couple of musclemen in Congress who think they have a right to tell everybody else that they have to do their bidding." Rep. Dan Burton, R-Ind., also was critical of inserting the vaccine language after the conference committee had adjourned. "It sucks," he told Congress Daily that night.
The important thing in the Prize Fund approach is that it separates the market for innovation from the market for the physical copies of the drug. If passed, it will eliminate the marketing monopolies for all medicines. Competition would lead to much lower prices. When new drugs are priced the same as off-patent generic products (at the cost of making copies), doctors, governments, insurance companies and employers would no longer have an incentive to restrict access. Medicine would be prescribed on the basis of medical merits, rather than cost effectiveness.
The Paris Accord II conference linking creators of content with consumers continues with a workshop today on film, video and art. Here is a long-distance Flip video snap of media futurist 
Update: This was a great panel, with a lot of spirited debate between the musicians who sample from others' work and those who don't. Hank Shocklee: "I was sampling before they made up the word. Many of these laws were written because of me." Various ideas were discussed to compensate musicians whose work is sampled by others, as well as to address numerous other problems in compensating musical creators. As the Paris Accord process goes forward, the group may be able to propose solutions.
Today, Nicole Allen (pictured left), coordinator of the Student PIRG 
The event features panelists including advocates, authors, musicians (including Hank Shocklee of Public Enemy), filmmakers, medical researchers and others. It is an effort to find common ground between the creative community and users of content, without the din created by participation of powerful copyright or patent holders and middlemen, most of whom seek restrictive copyright protections in national law and international treaties that harm democratic social discourse, hold back development of new medicines and sometimes even hold consumers criminally accountable for their "fair use" actions to use materials they have rightfully purchased. And, as Vera Franz pointed out, that while some of these powerful interests may characterize consumers as "pirates or communists, we are neither." The conference is one of a series of TACD events to build networks and communities to preserve access to knowledge and access to medicine and to ensure that these goals are achieved for both north and south countries globally.
A drug maker is using free speech claims in an attempt to invalidate prohibitions on off-label marketing to doctors. Currently, doctors can prescribe a drug for anything, but firms cannot pitch untested, unapproved uses to them. The incentive to do so, however, is there because a drug for a rare disease, with a limited market, makes a lot more money if sold for other more common diseases. Experts believe that a bad outcome could invalidate the entire scheme of FDA drug safety regulation. From today's New York Times story 
U.S. PIRG's Larry McNeely speaks in support of health care reform in front of the U.S. Capitol, joined by our 8-foot tall spokesconsumer Health Care Harry and friends. Photo by Brian Walker of our staff. More at our
Our giant spokesconsumer, Health Care Harry (an eight-foot tall interactive version of the Operation game’s “Cavity Sam”), will appear at the House Triangle outside the U.S. Capitol for a news conference Tuesday, 4 Aug at 10am in support of reform. He'll be joined by a doctor and our U.S. PIRG Health Care advocate, Larry McNeely. Harry's been on tour in Maine, with one of our senior consumer advocates, MASSPIRG's Deirdre Cummings. Watch them on 
U.S. PIRG's Health Care Advocate Larry McNeely has released a new report: 
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. 
The