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.
The law, scheduled to take effect on July 1, is believed to be the most stringent state effort to regulate the marketing of medical products to doctors. It would also ban nearly all industry gifts, including meals, to doctors, nurses, medical staff, pharmacists, health plan administrators and health care facilities.
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.
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.
Public Integrity report: A Record Year for the Pharmaceutical Lobby in '07
Our investigative reporter allies over at the Center for Public Integrity have a new report documenting a massive increase in influence-peddling by the pharmaceutical lobby (Big PhRMA). Excerpt:
Washington's largest lobby, the pharmaceutical industry, racked up another banner year on Capitol Hill in 2007, backed by a record $168 million lobbying effort, according to a Center for Public Integrity analysis of federal lobbying data. Among the industry's successes: getting two controversial laws extended and thwarting congressional efforts to restrict media ads for prescription drugs. The spending represents a 32 percent jump over 2006.
This Draft Guidance lowers the threshold for the promotion of off-label uses through the distribution of published studies, thereby reducing industry incentive to conduct more conclusive trials.
Currently, FDA approval is a major incentive for companies to test and evaluate their products. Once a medication is approved for any use, drug companies have incentive to study that product for use in additional indications.
Creating a pathway to more off-label marketing reduces the incentive to obtain FDA approval for new indications.
Under the Draft Guidance, a company would be able to disseminate a trial that finds positive data for any unapproved use, thus reducing the incentive to conduct more detailed research that might contradict the initial finding...In conclusion, the Prescription Project and other organizations listed above urge the FDA
not to issue the Draft Guidance in its current form, which would encourage the pharmaceutical industry to expand marketing practices which have been found to be illegal by government fraud investigations and successful litigation by government and consumers. We urge the FDA to hold public hearings to consider under what circumstances, if any, the industry should be allowed to market products for off-label indications.
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.
Court to hear cases affecting consumer state law rights to sue corporations
The Supreme Court has accepted petitions on two more product liability cases. The cases reflect a "concerted effort" by powerful interests to eliminate lawsuits under state laws for consumer harm, as Linda Greenhouse notes in her New York Times story Justices to Hear Cases on Product Liability:
"The proliferation of pre-emption cases on the court's docket in part reflects the considerable turmoil in the lower courts over the complex issues involved. It also reflects a concerted effort by the business community to push for federal pre-emption as a shield against state courts."
As we have previously noted, several Bush administration safety agencies (CPSC and also the FDA and NHTSA at least) have boldly asserted powers Congress never gave them: to preempt state laws by rule. Further, "a merry band" of industry lawyers moving back and forth between K St. lobby houses and the administration is running a political campaign against consumer legal rights.
The new cases concern whether the federal tobacco warning label law preempts state law claims that "low-tar and nicotine" promises are deceptive and whether an FDA-approved drug company label immunizes the firm from lawsuits by victims of side-effects. This case, according to Greenhouse, concerns
"a guitar player who suffered the career-ending amputation of her right arm after being injected in a hospital with an anti-nausea drug."
The story also notes another preemption case, Medtronic, heard in the Court late last year. We are friends of the court in that case, on behalf of the victim of a failed medical device made by the firm.
Major Rx Safety Bill Conference Report Passes House
House Passes Prescription Drug Safety Reforms -- Senate to follow
Statement by U.S. PIRG Consumer Health Care Advocate Paul Brown:
"The drugs in our medicine cabinets will be safer because of today's Congressional action. The reforms are the type of strong medicine needed to protect all Americans from unsafe drugs. The drug industry opposed many of these safety reforms, but in the end there were too many headlines about dangerous drugs.
The full release is below the jump. Senate will act tomorrow.
For Immediate Release: September 19, 2007 For More Information: Paul Brown, U.S. PIRG (202) 546-9707 ext 304
House Passes Prescription Drug Safety Reforms -- Senate to follow
The House today passed significant reforms to the Food and Drug Administration’s drug safety review system. Part of a comprehensive FDA bill, the bill was a compromise between Senate and House legislation that passed overwhelmingly earlier this year. The bill, which includes strong consumer protections, will be voted on in the Senate tomorrow.
Statement by U.S. PIRG Consumer Health Care Advocate Paul Brown:
"The drugs in our medicine cabinets will be safer because of today's Congressional action. The reforms are the type of strong medicine needed to protect all Americans from unsafe drugs. The drug industry opposed many of these safety reforms, but in the end there were too many headlines about dangerous drugs. Congress had to act, and we're pleased they did. In recent years safety problems with drugs like Vioxx, Paxil and Avandia have made consumers question whether the drugs they are taking to keep themselves healthy are causing more harm than good. The reforms strengthen the FDA's drug safety review process, and they hold drug makers more accountable to consumers. For a number of years, the FDA's system for reviewing the safety of drugs has been broken. Today's action by Congress takes steps to solve our drug safety problems."
The Food and Drug Administration Amendment Act will:
Make more information about drug studies available to researchers, doctors and patients by posting the results of most clinical trials on-line. Drug makers will no longer be able to bury unflattering studies about a drug’s side effects.
Strengthen conflicts-of-interest rules for scientists who serve on FDA drug safety panels by limiting the number of scientists with financial ties to drug makers by 25 percent over five years.
Grant the FDA the authority to issue fines of up to $10 million for drug makers who fail to complete follow-up safety studies. In the past, drug makers failed to complete drug safety studies nearly 70 percent of the time.
Add $225 million from drug industry user fees for follow-up safety studies (post-market drug safety reviews). This is a significant increase in user fees being dedicated to drug safety.
Congress must pass the Food and Drug Administration Amendment Act by September 30 to avoid layoffs at the FDA. The bill includes prescription drug user fee reauthorization that provides nearly $400 million of the Food and Drug Administration's $1.5 billion budget.
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U.S. PIRG is the federation of state Public Interest Research Groups. State PIRGs are non-profit, non-partisan public interest advocacy organizations.
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.
Some have speculated on a possible cause for Mattel products suddenly being loaded up with lead paint from a factory in China: the manufacturer used the same production line for Chinese toys, with weaker standards, and contaminated it before painting U.S. toys. You've all seen those notes on the candy wrappers -- "contains no peanuts, but may have been produced on a machine that processed peanuts"?
There's an interesting new interview by Alternet's Vanja Petrovic -- The Toxic Chemistry of Everyday Products -- with Mark Schapiro, author of a new book that explains that
companies that manufacture hazard-free products for the European Union often produce toxin-filled versions of the same items for America and developing countries.[...] some companies, whether American or international, often have two production lines: one that manufactures hazard-free products for the European Union and another that produces toxin-filled versions of the same items for America and developing countries.
The interview goes on to explain what corporate "logic" goes into this decision, when they could simply manufacture all products to the safer European standards.
For years, we've advocated that the U.S. CPSC ban toxic phthalates in toys. As the interview points out, Europe has.
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.
Senate Passes Drug Safety Legislation
Bill Will Protect Patients From Unsafe Medicines
Excerpt: The Senate bill gives the FDA new powers to issues fines to drug companies if they fail to do follow-up safety studies, or if they air false or misleading TV ads. In a rebuff to the drug industry, an amendment by Senator Charles Grassley (R-Iowa) to substantially increase those fines passed by more than a two to one margin. FULL RELEASE:
For Immediate Release Wednesday, May 9, 2007
For More Information: Paul Brown (202) 546-9707
Senate Passes Drug Safety Legislation
Bill Will Protect Patients From Unsafe Medicines (Washington, DC)— In a victory for consumers, the Senate today passed the "Food and Drug Administration Revitalization Act" sponsored by Senator Ted Kennedy (D-Mass.) by a vote of 93 to 1.
The bill attempts to please both the powerful pharmaceutical industry and consumer groups. It increases the amount of money the FDA receives in fees from drug makers to speed the approval of new drugs, and includes language to protect consumers from unsafe prescription drugs.
Over the next five years, the bill will increase by $225 million the amount of drug industry user fee money dedicated to drug safety.
"Congress is telling the FDA that they must put safety first," said U.S. PIRG Consumer Health Care Advocate Paul Brown. "The American public will no longer tolerate dangerous and deadly drugs like Vioxx, Paxil, and Accutane approved by an agency that has been much too cozy with the industry it is supposed to be regulating."
The Senate bill gives the FDA new powers to issues fines to drug companies if they fail to do follow-up safety studies, or if they air false or misleading TV ads. In a rebuff to the drug industry, an amendment by Senator Charles Grassley (R-Iowa) to substantially increase those fines passed by more than a two to one margin. Unfortunately, an amendment by Senators Richard Durbin (D-IL.) and Jeff Bingaman (D-NM) to reduced conflicts-of-interests on FDA advisory committees failed to pass on a tied vote, 47 to 47.
"Even without the stronger conflict-of-interest amendment, this bill is a step in the right direction," said Brown. "For too long the "D" in the FDA has stood for 'dysfunctional'. This legislation will begin to change that by refocusing the agency on its original mission of ensuring that American consumers receive safe medicines."
The drug safety provisions were added to must-pass prescription drug user fee legislation that provides nearly $400 million or 20 percent of the Food and Drug Administration’s $1.5 billion budget.
The House is scheduled to debate similar legislation in the Energy and Commerce Subcommittee on Health by the end of May, and both Houses are expected to pass drug safety/prescription drug user fee legislation by the end of July.
-30-
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.
The state PIRGs have backed numerous programs -- from expanded bulk buying pools (co-ops) to limits on drug company gifts to doctors -- to lower the cost of prescription drugs. We're backing first 100 hours Congressional efforts to overturn the no-negotiation provision of the 2003 Medicare Part D law passed in the middle of the night after a 3-hour vote characterized by much arm-twisting from former Majority Leader Tom Delay. That law prohibited Medicare from negotiating with drug manufacturers for the best price. Here's a letter to the editor Save Billions on Drugs from PIRG consumer advocate Paul Brown that appeared in today's Washington Post.
Save Billions on Drugs
Thursday, December 21, 2006; A28
Savvy shoppers know that buying in bulk saves money. That is why an "overwhelming majority of Americans" (85 percent) want the government to negotiate bulk purchase discounts for the Medicare drug program [news story, Dec. 9].
No matter how the drug industry tries to spin it, the 2003 law that prohibits Medicare from negotiating bulk discounts is a sweetheart deal.
Some in Congress admit it. Rep. Zach Wamp (R-Tenn.) said recently, "It looked like we were in the back pockets of the prescription drug companies, and some of us were" [front page, Dec. 10].
The new leadership in Congress has called for a change in the law to allow Medicare to negotiate bulk discounts. They should make this change as soon as possible. It will save taxpayers, who pay for nearly 75 percent of the drug program, tens of billions of dollars.
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.
In 2004, for example, COPIRG and Environmental Colorado helped run a successful citizen campaign to enact Amendment 37, to dramatically boost the use of renewable energy by electric utilities.
Next week, Oregon State PIRG (OSPIRG) and CALPIRG are each backing several important consumer ballot questions. In Oregon, along with Consumers Union (publisher of Consumer Reports), OSPIRG is urging a Yes on Measure 42, to ban the use of credit scoring for insurance decision-making. The insurance industry has not been able to prove an actuarial relationship between your credit report and whether you'll be a good driver or homeowner, nor has it been able to discount independent studies that show that people of color score lower than whites, suggesting that they may be using credit scoring as a proxy for otherwise illegal rating factors. Finally, of course, it hasn't been able to explain the number of mistakes in credit reports.
OSPIRG (previous blog) is also backing Measure 44 to expand Oregon's successful prescription drug buying pool to leverage lower prices for the one million Oregonians lacking drug coverage.
OSPIRG also urges Yes on Measures 46 and 47: With no current limits on campaign contributions, this pair of measures would enact comprehensive campaign finance reform in Oregon. Measure 46 amends the constitution to allow campaign contribution limits. Measure 47 enacts low contribution limits, bans direct contributions from corporations and labor unions, and adds disclosure requirements.
CALPIRG is supporting three statewide propositions (citizen votes go by different names in different states).
CALPIRG urges YES on Prop 87, the Clean Alternative Energy Act to tax oil companies who are drilling for oil on California land and use the funds for clean energy development.
CALPIRG also opposes two Sacramento County ballot questions: No on Q and R, two corporate welfare proposals dumping the costs of a new basketball arena for the Sacramento Kings on taxpayers.
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.
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).
Uninsured Consumers Still Pay The Prescription Price
We released a new survey on prescription drug costs today. Paying The Price, written by PIRG national consumer advocate Paul Brown, finds that consumers without health insurance pay too much for prescription drugs. The report compared the drug prices paid by 46 million uninsured Americans with those paid by the federal government, which negotiates low prices with the drug industry in its bulk purchasing for veterans, members of Congress and others, as well as with the prices that the uninsured Americans would pay in Canada, where drug prices are regulated.
Uninsured Americans pay 60 percent more on average than what the federal government pays for the prescription drugs we surveyed.
Regionally, uninsured consumers in the Northeast pay the highest prices for the 10 drugs we surveyed, followed by the West, South, and Midwest. Among the cities we surveyed, the uninsured in Boston, Sacramento, San Francisco, and Hartford (CT) pay the highest prices. Des Moines has the lowest prices among the cities we surveyed, but uninsured Des Moines residents still pay 46 percent more than the federal government for the same drugs.
Uninsured Americans pay twice as much for drugs purchased at local pharmacies as they would pay if they purchased the same drugs from a Canadian pharmacy.
The report makes a number of recommendations for reform, available here, including the establishment of bulk prescription buying pools.
Here's a blog entry from NYPIRG's Blair Horner explaining how the New York legislature nearly passed legislation last month establishing a buying pool cooperative to lower prescription drug prices, but was blocked by the drug lobby. The good news-- the bill could come up again before the elections. You can follow Blair's weekly posts from Albany here.
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?
Get Free Music. Fight Acne. Stay Cool. That's a link to a web ad by Galderma Labs promoting the acne drug Differin to teens. Two free downloads for signing up (doesn't she looks psyched?), 7 more for filling a prescription and ten more downloads for renewing it. MASSPIRG and USPIRG have joined the Prescription Access Litigation Project and other groups in comments to the FDA calling for a ban on coupons for prescription drugs.
The coupons are even worse ideas when marketed to kids. Ask your doctor for drugs so you'll get "free music?" Bad idea. Here's why coupons for prescription drugs are a bad idea for all consumers, from our comments:
We see deceptive marketing by pharmaceutical companies as one of the primary factors driving up the cost and inappropriate use of prescription drugs in the United States. Coupons, as a type of Direct To Consumer Advertising (DTCA), contribute to the negative effects of drug marketing and represent one of its crassest forms...
1) Coupons interfere with the doctor-patient relationship;
2) Coupons foster overuse of brand-name drugs at the expense of generic drugs;
3) Coupons inevitably affect the perception of risk and benefit;
4) For consumers with government prescription coverage, coupons can constitute an illegal kickback.
The purpose of the comments was to suggest criteria for a proposed study of coupons. We make a number of recommendations on the structure of the study.
The Food and Drug Administration, once known as the world's gold standard for safety, is now simply the latest Bush administration agency to assert, apparently for political reasons, that it knows best when it comes to protecting the public, and that the states and their stronger laws can take a seat on the sidelines. According to the Wall Street Journal (14 January 06) in the story FDA Plan Would Aid Drug Makers In Liability Suits: Agency's Approved Labels Would Pre-empt State Law; Plaintiffs' Lawyers Object:
Inclusion of the new FDA policy in the long-awaited drug-labeling rule has sparked disagreements between FDA career officials and Bush administration appointees, according to people with knowledge of the matter.More:
In 2004, the Office of the Comptroller of the Currency (OCC) issued two sweeping rules restricting state authority over national banks and their operating subsidiaries (our website OCCWatch here). In fall 2005, the National Highway Traffic Safety Administration (NHTSA) proposed a rule similar to FDA's: car and truck manufacturers would be immunized from state tort claims if their vehicles meet its modest safety tests (previous blog).
The FDA's proposed rule is designed to give drugmakers protection from state law claims in court if a drug's warnings meet FDA's standards, no matter how weak they are. The Journal explains:
The policy could help companies argue they weren't required to warn consumers about a potential risk when the FDA had determined that the safety issue didn't warrant inclusion on a medicine's label. The new policy, which would address state liability statutes, has been written into a broad new drug-labeling rule that is likely to be issued shortly, according to people with knowledge of the matter, though the rule has been repeatedly delayed.
Neither FDA nor NHTSA have issued final rules yet, and the rules could be challenged in court as exceeding the power granted the agencies by Congress, or interpreted negatively by a court for the same reason, but the OCC's rules are currently in force.
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.
Unfortunately, that same final Defense Spending bill included a sweeping drug company immunity provision, supposedly to urge greater vaccine production but with a much broader impact. Here's some details from Public Citizen. My previous blog with a link to our hill letter.
In a letter today, U.S. PIRG and five other leading consumer and civil justice groups urged Senators to oppose efforts to pass a defense spending bill that includes a sweeping immunity clause for drug manufacturers. While the prvision is ostensibly to urge them to make adequate stocks of pandemic vaccines, its immunity is broad. News release.
Over the weekend, without a vote, Senate Majority Leader Bill Frist (R-TN) attached a 43-page provision granting drug companies unprecedented and sweeping immunity from liability lawsuits to a conference report on the so-called "must-pass" defense spending bill. It's a shocking giveaway to some of the biggest campaign donors in Washington, has little to do with increasing vaccine supplies and could apply even to existing over-the-counter drugs if used in a pandemic. Any conduct less than willingly injuring or killing people appears to be protected from lawsuits for harm ("willful misconduct" is defined as evidence that the drug company had actual knowledge that its product would injure or kill someone). Here's more:
The provision is on pages 423-465 of the Conference Report on HR 2863, Defense Appropriations. Here's an excerpt from a letter consumer groups including USPIRG sent up to the hill last week opposing a still-shocking but slightly less unfair version of the drug company protection proposal.
We recognize the urgent need to prepare adequately for infectious disease outbreaks. It may very well be that during public health emergencies expedited approval of vaccines and drugs is necessary for the nation’s security...Broadly shielding manufacturers from responsibility for gross negligence, recklessness and other egregious behavior and leaving victims with no recourse, may cause more public harm than the pandemic disease itself. As doctors and public health officials have warned, if individuals know there is no remedy for injuries caused by the vaccine’s side effects or by a defective batch of vaccine, they are likely to refuse immunization, thus undermining efforts to contain outbreaks.
According to Rep. David Obey (D-WI), a conferee, Frist's action also was against promises repeatedly made that it would not be included. Obey said in Congress Daily:
"For the last eight hours we have been dealing with a majority leadership that has stripped out of the appropriations process and the conference virtually every understanding in those bills...We've had the United States Senate ram down our throats an ANWR [Arctic National Wildlife Refuge] provision, and after we were assured in conference there would be no [liability language] three hours after the conference report we get 45 pages..."
As we head toward the PIRG-backed Wal-Mart Higher Expectations Week November 13-19th, today's New York Times has a good overview (free regis. req.) of how the skyrocketing health care costs that have pummeled uninsured (45 million strong) and under-insured (add another 30 million) Americans are now facing corporate America. The problem is, while corporate America finally recognizes it has a problem paying for health care, it has refused to embrace the best solution for corporations and citizens, single-payer national health care. The employer-based U.S. health care system is broken, and only single-payer can fix it. Meanwhile, the rest of the economy is starting to feel the pain of the broken system. Morton Mintz recently explained why single-payer is the answer in the Nation: Single-Payer: Good for Business.
It will be far easier to attract and retain a healthier work force than it will be to change behavior in an existing one. These moves would also dissuade unhealthy people from coming to work at Wal-Mart.
The story on the Wal-Mart memo is a great piece. It shows the paradox Wal-Mart faces. Wal-Mart's health care costs may be rising, but its health care plan isn't that good, so what should it do? One externality created by Wal-Mart's failed health care plan is that excessive numbers of the children of Wal-Mart "Associates" collect state Medicaid.
Wal-Mart's failure to adequately cover its workers places a massive burden on taxpayers. This spring, the state of Maryland nearly enacted legislation which would have required large companies to either provide adequate health care or pay increased taxes to compensate, since taxpayers pay for Medicaid (it's a joint state-federal burden, with the Congress trying to slough even more of the cost onto the states).
The Fair Share Health Care Fund Act was vetoed by MD Governor Bob Ehrlich in May, but activists hope the new Wal-Mart memo will help in their efforts to seek a veto override.
The Abelson story goes into some of the problems that other firms face paying for health care. Often their solution is to increase co-pays, deductibles and non-covered services or raise the employee share of the monthly health care costs. These band-aid solutions, and the vaunted employee choice solutions, don't fix the overall problem. Healthy, well-off people can make better health care choices than sicker, less-well-off people. A health insurance system in a country like the U.S. should fairly serve both groups, not only the former. Ours does not. Gimmicks to assist the healthy and well-off won't significantly lower health care costs; worse, many of these proposals may increase the burden on the poor and the sick.
The problem of the broken employer-based health care system ripples into other parts of the economy like a jagged festering wound from a rusty knife.
The looming threat of competition from Wal-Mart is used as an excuse by supermarket chains across the nation to insist on labor concessions -- hurting the standard of living of employees and further weakening the ability of labor to balance the interests of workers against those of management, as this labor backgrounder points out.
The problem of rising health care costs isn't limited to retail workers and supermarket chains. GM and Ford have claimed rising health care costs cut their global productivity and they may be right. "GM says that $1,500 of the price of every new vehicle it sells goes towards health care for past and present employees," according to the Economist. GM and Ford compete with companies in countries with nationalized health care systems. [Of course, they've also made a lot of bad or even stupid bets on gas-guzzling SUVs and monster trucks. If those behemoths were moving off the lots, they wouldn't have to squeeze employee and retiree health care.]
No big firms have yet embraced single-payer, which took a bad rap twelve years ago in the famous Harry and Louise ads run by the health insurance lobby to kill the Clinton health plan (good background here from Center for Media and Democracy). Yet, we suppose it is encouraging that even the U.S. Chamber of Commerce has gone so far as to join an annual "Cover the Uninsured Week" coalition, which provides useful information and educational resources on the problems of lack of health care. Unfortunately, I haven't seen any of the suits from the Chamber urging members of Congress to back HR 676, The United States National Health Insurance Act. It's a bill with 50 co-sponsors by U.S. Rep. John Conyers to reform the health care system. It's comprehensive and it's going nowhere while the House leadership keeps pushing band-aids like Medical Savings Accounts and Association Health Plans. As Consumers Union points out: MSAs (or HSAs) are good for the wealthy and the healthy-- no one else. And as for AHPs, Consumers Union points out that these are not fully regulated health care plans.
We can only hope that the glare of the spotlight being placed on some of America's largest companies, Wal-Mart, GM and Ford and others, and their claim that they cannot afford to pay for health care will force Congress to re-visit the important idea of single-payer national health care. The solution is not to bash single-payer. It's too look at it as a potential solution to an employer-based system that is broken beyond repair. We need to force these stubborn companies to revise their obstinate opposition to the single-payer solution that makes sense for corporate America and the American people, too.
It explains the health care burdens Wal-Mart dumps on all of us:
In 2002, 43 million non-elderly Americans lacked health insurance coverage – an increase of almost 2.5 million from the previous year. Most Americans receive their health insurance coverage through their employers. At the same time, most of the uninsured are working Americans and their families, with low to moderate incomes. Their employers, however, either do not offer health insurance at all or the health insurance offered is simply unaffordable.
Among these uninsured working families are a significant number of Wal-Mart employees, many of whom instead secure their health care from publicly subsidized programs. Fewer than half – between 41 and 46 percent – of Wal-Mart’s employees are insured by the company’s health care plan, compared nationally to 66 percent of employees at large firms like Wal-Mart who receive health benefits from their employer. In recent years, the company increased obstacles for its workers to access its health care plan.
The report goes on to detail the myriad other labor costs Wal-Mart externalizes and passes on to the rest of us:
The Democratic Staff of the Committee on Education and the Workforce estimates that one 200-person Wal-Mart store may result in a cost to federal taxpayers of $420,750 per year – about $2,103 per employee. Specifically, the low wages result in the following additional public costs being passed along to taxpayers:
• $36,000 a year for free and reduced lunches for just 50 qualifying Wal-Mart families.
• $42,000 a year for Section 8 housing assistance, assuming 3 percent of the store employees qualify for such assistance, at $6,700 per family.
• $125,000 a year for federal tax credits and deductions for low-income families, assuming 50 employees are heads of household with a child and 50 are married with two children.
• $100,000 a year for the additional Title I expenses, assuming 50 Wal-Mart families qualify with an average of 2 children.
• $108,000 a year for the additional federal health care costs of moving into state children’s health insurance programs (S-CHIP), assuming 30 employees with an average of two children qualify.
• $9,750 a year for the additional costs for low income energy assistance.
Wal-Mart externalizes tremendous other costs including environmental costs. We'll have more on Wal-Mart as we get closer to Higher Expectations Week. And we'll have more on the costs of health care.
WIPO treaty opposed/limits on copyrights and patents proposed
Two items on protecting access to knowledge and medicine from one-sided patent and copyright protection:
(1) Here's a letter (15 Oct 05) to Congress from CPTech, U.S. PIRG and others opposing a dangerous new proposed broadcast/webcast treaty moving through the UN's World Intellectual Property Organization (WIPO). Previous blog here explains how it grants extraordinary intellectual property rights to firms, above and beyond existing copyright protections.
(2) An International Commission convened by the Royal Society of Arts in London has issued an important proposal: the Adelphia Charter.
The Charter sets out new principles for copyrights and patents, and calls on governments to apply a new public interest test. It promotes a new, fair, user-friendly and efficient way of handing out intellectual property rights in the 21st century.
Members include Larry Lessig of Stanford Law School (also Chair of the Creative Commons Board) Jamie Love of CPTech (Jamie and CPTech have been leaders in the fight to bring low-cost AIDS and other medicines to Africa, as well as in fighting the WIPO broadcast/webcast treaties), Jamie Boyle of Duke Law School, Nobel Laureate Sir John Sulston (who has worked to keep the Human Genome Project "open-source" (article)) and others.
AP reports in the Washington Post (free registration required) that a Texas jury has awarded $253 million to the widow of a "man who took the once-popular painkiller Vioxx." Here's a link to PIRG's Drug Safety page, where we are urging passage of an FDA reform bill, S 930 (Grassley-R-IA, Dodd-D-CT) to force the agency to do a better job. Currently, the FDA is extremely limited in its ability to both identify dangerous drugs and inform doctors and consumers about drug related health risks.
House Limits Damages To Medical Malpractice Victims
As expected, but by a much narrower margin than supporters of limiting rights of victims of doctor or drug company malpractice wanted, the House today passed HR 5 on a 230-194 vote. The bill has a dubious future in the Senate, where Dr. Frist has failed several times in past sessions to come close to passing the onerous bill. Previous blog for details.
California Law Reining In Drug Company Gifts To Doctors Takes Effect
CALPIRG-sponsored legislation, SB 1765, limiting gifts to doctors by drug company sales flacks known as "detailers" takes effect today. Excerpt from CALPIRG's release from the 2004 bill signing: "The bill gives the force of law to a currently unenforceable voluntary code and caps the amount of money drug companies can spend wooing doctors each year. It also requires drug companies to make their internal guidelines on gift-giving available on their web sites." Read a 2004 report by CALPIRG on drug detailing.
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 
I blogged last week on a 
Yesterday, the 
Election Day is about elections, but it is also about citizens bringing important issues to the ballot, in states where initiative and referendum is allowed (see 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: 
We released a new survey on prescription drug costs today. 
consumers. 