Archive for the ‘Pharmaceuticals’ Category

March18

First SOPA then ACTA, now TAFTA- here we go again

By: Burcu Kilic

Our Trans-Atlantic Call for Exclusion of Intellectual Property from EU-US Trade Talks

US trade policy is currently focused on the Trans-Pacific Partnership (TPP), for which President Obama hopes to complete negotiations by October. If the agreement is concluded according to plan, the TPP will include the United States, Canada, Mexico, Peru, Chile, New Zealand, Australia, Brunei, Singapore, Malaysia, and Vietnam.  Japan is signaling its interest to join and Korea would possibly follow Japan. The treaty would remain open for other countries to join as well, so long as they meet the required standards.

Meanwhile, along the Atlantic, the US is preparing to launch negotiations for a Transatlantic Free Trade Agreement (TAFTA)—or what is being touted as the Transatlantic Trade and Investment Partnership (TTIP).

The establishment of a Trans-Atlantic partnership is not a new idea; the possibility of creating a Trans-Atlantic Free Trade area had been discussed occasionally in the past, especially during the 1970s and 1980s. However, informal discussions failed to solidify into something more concrete.

The United States and the European Union have both entered into economic partnership agreements across the globe, but never before with each other. In 2011, American and European politicians keen on “shaping globalization” (i.e. setting rules for the 21st century) outside the official global forums set up the High-Level Working Group on Growth and Jobs (HLWG) to assess the feasibility of a comprehensive transatlantic trade agreement.  The deal between the world’s two most important economic powers hopes to be a “game-changer.”

The BRICS countries — Brazil, Russia, India, South Africa and perhaps most notably China – have not been invited to either negotiation. It may be the case that these deals aim to better prepare the EU and the US for an upcoming economic battle with the BRICS and other emerging powers.  The BRICS countries have a combined GDP now equivalent to that of the EU or the US.  “This is about the weight of the western, free world in world economic and political affairs,” declared EU Trade Commissioner De Gucht.

The HLWG released its interim report in 2012 identifying policies and measures to increase EU-US trade and investment. The interim report noted that, “it would not be feasible in negotiations to seek to reconcile across the board differences in the IPR obligations that each typically includes in its comprehensive trade agreements.”

However, industry groups soon realized that the so-called Trans-Atlantic Free Trade Agreement presents a perfect opportunity to set “golden standards” for IP regulation and enforcement, which emerging markets like China and India could then be pushed to accept. Groups like PhRMA urged the EU and US to include IP to further strengthen the international regime. Eventually, the HLWG changed its position and is now recommending the inclusion of an IP chapter, although a “limited” one. The Final Report issued by the HLWG recommends that TAFTA negotiations “address a limited number of significant IPR issues of interest to either side, without prejudice to the outcome.”

It is not clear what the HLWG is trying to say. The US and EU regimes are not alike. Geographical indications, for instance, continue to create a transatlantic trade conflict between the US and EU. They have fundamentally different philosophies on the issue.  The EU is committed to enhancing its vast gastronomic heritage of excellence, and pushes for more restrictive rules. The US wants to maintain the status quo to help giant companies like Kraft sell items like “parmesan” cheese around the world.

Any attempt to boost patent or copyright rules in favor of rights holders and against the interests of consumers would be a significant mistake and invite major public resistance. The defeat of ACTA in the EU and the overnight death of SOPA in the US were no accidents. They should serve as a stark reminder to policymakers on either side of the Atlantic.

It goes without saying we will not hold back from raising our voices once again in defense of our fundamental rights to free speech and health, and to uphold the benefits of an open knowledge economy.

To read the declaration of  transatlantic coalition of 45 consumer, public health and Internet freedom groups, visit http://www.citizen.org/ip-out-of-tafta.

Posted in: Activism, Consumer Protection, Pharmaceuticals, Trade0 comments

October9

Meningitis outbreak shows failure in oversight of compounding pharmacies

By: Mike Carome

The now widely publicized outbreak of life-threatening fungal meningitis in back-pain patients linked to steroid injections prepared by a compounding pharmacy highlights the failure of the Food and Drug Administration’s (FDA’s) regulatory oversight of drugs prepared and sold by such pharmacies. What is particularly tragic for the families of those who have been sickened or killed by the tainted drug is that this situation was completely avoidable.

The steroid injections, distributed by the New England Compounding Center in Framingham, Mass., have been linked to at least 119 infections in 10 states, and as many as 13,000 people have been exposed. The contaminated injections have been recalled, along with all other products distributed by the New England Compounding Center.

The large-scale production of a drug — in this case, a drug that is intended to be sterile and injected into patients — appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce.

Indeed, prior warning letters from the FDA to the New England Compounding Center and other compounding pharmacies appear to indicate that the agency considered these pharmacies to be engaged in drug manufacturing. The pharmacies were therefore considered subject to the safety and effectiveness standards required for approval of new drugs, as well as the rigorous manufacturing standards designed to ensure that drugs are sterile and uncontaminated with such germs as bacteria or fungi before being sold and distributed.

However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients. By not aggressively enforcing regulations related to drug manufacturing by compounding pharmacies, the FDA has perpetuated a double standard: Traditional drug manufacturers must adhere to rigorous drug-safety standards intended, for example, to prevent the contamination of their products. But so-called compounding pharmacies engaging in large-scale drug production do not. This double standard has resulted in the unfolding public health catastrophe involving hundreds and potentially thousands of patients who received steroid injections for back pain.

Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible. If current statutes and regulations provided the FDA with authority to prevent this disaster, senior FDA officials should be held accountable. If holes in the agency’s existing legal authority are identified, Congress should act immediately to pass legislation to remedy the situation.

Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group

Posted in: Consumer Protection, Health, Pharmaceuticals, Product Safety, Regulation, Uncategorized1 comments

October4

“Read all about it!” Your favorite watchdog in the news . . .

By: Guest blogger

There are no days off for the people’s lobbyist. Public Citizen’s corporate and government watchdogs, consumer advocates and champions of public interest had another busy week last week and have kept the news media busy too. Here are a few highlights:

On Sept. 27, Public Citizen’s Health Research Group released a study finding that state settlements with drug companies over Medicaid fraud are at record highs, and many states recover more than they spend on enforcement. An AP story about the report ran the day the report was released and was quickly picked up by The Washington Post and other newspapers around the nation. In the story, Public Citizen’s Dr. Sammy Almashat, the researcher who wrote the report, is quoted as saying, “It should come as no surprise that states facing Medicaid budget shortfalls are finally deciding to root out fraud that has likely cost their taxpayers billions of dollars of the years.” Bloomberg wrote its own report on the study, and due to the pervasiveness of prosecutions by state governments, local newspapers were on top of the story as well. They included the Honolulu Star-Advertiser, Keys News, The Texas Tribune and the Lexington Herald Leader. Democracy Now! reported on the study, highlighting our contention that increased fees to pharmaceutical companies are still not enough curb their illegal behavior.

Also last week, Tyson Slocum, director of Public Citizen’s Energy Program, debated The Cato Institute’s Jerry Taylor on CNBC. Slocum slammed Sen. Ron Paul’s (R-Ky.) proposal to repeal the federal gas tax, calling it a “radical view.” Slocum highlighted the need to reform the tax and proposed a “vehicle miles driven tax,” which would more “evenly distribute the burden” of the tax. He reminded viewers of the country’s “huge infrastructure needs” and concluded that “repealing the gas tax is irresponsible.”

Slocum was busy on another front, promoting the need for strict sanctions, rather than fines, for companies that violate trading rules in the electricity market. The Federal Energy Regulatory Commission is considering sanctions against JPMorgan for its abuse of trading rights in Southern California. In the Los Angeles Times, Slocum praised this move, stating “When a company is faced with significant sanctions, not just a financial slap on the wrist, it’s going to take it seriously.”

And last Friday, Ben Protess with The New York Times DealBook quoted Public Citizen in his piece on commodity futures trading, and a recent court decision to strike down a rule designed to stem speculation in the oil market. Our point was clear: “The winners and losers from this ruling are clear: Wall Street win, consumers lose.”

For all of Public Citizen in the news, check out our media page.

Miriam Diemer is @Public_Citizen‘s communications office intern.

Posted in: Activism, Consumer Protection, Energy, Pharmaceuticals, Uncategorized0 comments

July20

We Can End AIDS: Join Us this Tuesday in Washington, D.C.

By: Burcu Kilic

Acquired immune deficiency syndrome (AIDS) was first recognized in the United States in 1981. The Human Immunodeficiency Virus (HIV) was identified soon after in 1983. By the mid-1980’s, the disease was recognized as an international epidemic which had spread throughout most of the world. Millions have lost their lives since.

Three decades later, we may finally have an opportunity to end AIDS."We Can End AIDS 2012"

This year, new science demonstrated that treatment can also be effective as HIV prevention.  For the first time it is becoming possible to model an end to the epidemic. Activists’ calls for an AIDS-free generation have been echoed worldwide.

But ending AIDS will depend in part on massively scaling up access to treatment. A major obstacle is the monopoly power of the giant pharmaceutical companies.

In 2000, basic HIV treatment cost up to $15,000 per person, per year (ppy). In developing countries, treatment was out of reach for all but the very wealthy, and HIV was a death sentence.

Then, activists working together across borders and increasing availability of generic medicines facilitated a treatment revolution, eventually driving basic HIV medicine prices to under $150 ppy – a 99% cost reduction.  Today, antiretroviral (ARV) medicines provide eight million people in low- and middle-income countries with long term hope for a healthy and long living future.

But millions more still await access, and lifelong AIDS treatment requires access to newer and more potent drug regimens, due to drug resistance.

Unfortunately, most newer ARVs are under the monopoly control of multinational pharmaceutical companies. The high treatment costs for these medicines threaten to block the remarkable progress already achieved and impede the goal of “getting to zero.”

To continue the treatment revolution and seek an end to AIDS, we need competition and access not only for off-patent ARVs but also for the patent-protected and very expensive second- and third-line ARVs. Public Citizen’s Global Access to Medicines Program is working with partners in more than one dozen countries to challenge Big Pharma’s monopoly abuses and realize this vision.

We are also fighting to protect access to medicines in the proposed Trans-Pacific Partnership (TPP), a free trade agreement under negotiation now between the United States and countries in Latin America and Asia. The Office of the United States Trade Representative (USTR) has advanced a Big Pharma wish list that would lengthen, strengthen and broaden pharmaceutical monopolies throughout the region. We are inspiring governments and health advocates fight back.

We envision a very different Asia-Pacific region partnership–one that advances pharmaceutical access and innovation simultaneously.  We believe better public policy is possible. We firmly hold to the promise of an “AIDS-free generation”. Getting there requires standing up to Big Pharma, promoting competition, and expanding access to medicines.

That’s why, this Tuesday Public Citizen’s Global Access to Medicines Program will join the We Can End AIDS March and ask for “accountability from Big Pharma and government officials around the world”.

We need your support to create a future free of AIDS. Please join us on Tuesday and let’s raise our voices against Big Pharma.

Posted in: Activism, Health, Pharmaceuticals, Trade0 comments

June28

We Still Need Medicare-for-All

By: Robert Weissman

It will take some time to digest the Supreme Court’s decision today, but it appears to have averted some terrible jurisprudence that might have very seriously restricted the government’s overall ability to regulate the economy and protect citizens.

In upholding most of the Affordable Care Act, the Supreme Court lets stand legislation that offers some important benefits, but only to a portion of those who are uninsured, and will predictably fail to solve our nation’s health care crisis.

However the health reform law ultimately plays out, we know two things for certain: Tens of millions of Americans will remain uncovered as will tens of millions of under-insured who will remain at risk of financial ruin if a major illness strikes and it will leave the private health insurance and pharmaceutical industries in charge of prices and life-and-death treatment decisions.

There is a single solution to the challenges of providing coverage to the 50 million who are uninsured that would curb out-of-control health care costs and provide a humane standard of care to all who enter the medical system. That solution is an improved Medicare-for-All, single-payer system.

The improved Medicare-for-All approach starts with the premise that health care is a critically-needed right that must be afforded to all, irrespective of any individual’s ability to pay for care. It solves the problems of 50 million uninsured Americans simply and directly by establishing that everyone is covered by the improved Medicare-for-All system. Everybody in, nobody out.

Improved Medicare-for-All would prevent the deaths of the 45,000 Americans who die every year from lack of health insurance. It would eliminate the hundreds of thousands of medical bankruptcies — affecting millions of Americans every year — that occur because people can’t pay their medical bills. These deaths and economic tragedies are entirely preventable; a system that permits them to continue is morally repugnant and must be replaced.

The improved Medicare-for-All approach would eliminate the greatest waste in the health care system: the needless costs imposed by the private health insurers. These firms impose hundreds of billions of dollars of excess cost on us via their excessive profit-taking and executive compensation, their marketing expense, their vast bureaucracies devoted to denying care and their imposition of massive paper-pushing obligations on actual health care providers.

Continue Reading

Posted in: Activism, Ethics, Health, Litigation, Pharmaceuticals, Social Justice, Uncategorized0 comments

© Copyright . All Rights Reserved.