Archive for the ‘Pharmaceuticals’ Category

Antibiotic Resistance Coalition - photo courtesy of ReAct

Antibiotic Resistance Coalition – photo courtesy of ReAct

Last Thursday, Public Citizen joined partners in the Antibiotic Resistance Coalition in releasing a declaration on the dire threats posed by antibiotic resistance and urgent steps that must be taken to avert its dangers.

Additionally, the coalition called on World Health Organization member states to pass a critical resolution calling for measures to combat antimicrobial resistance, including antibiotic resistance, at the 67th World Health Assembly.

The implications of the growing trend of antibiotic resistance are frightening, to say the least. Human beings rely on antibiotics for treatment of the most basic bacterial infections. Without effective antibiotics, most surgery, organ transplantation and chemotherapy would be impossible. The growing trend of antibiotic resistance is making that possibility all too real.

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Thirty-three years ago today, the World Health Organization adopted the International Code of Marketing of Breastmilk Substitutes (AKA the “WHO Code”) to promote breastfeeding and limit formula companies’ influence over women’s infant feeding decisions. Today, most health care facilities and the largest formula makers continue to violate the Code in the U.S. and worldwide.

To mark the anniversary of the WHO Code, more than 20 organizations and thousands of moms and citizens today are participating in a day of action led by Public Citizen, directed at the largest formula makers in the U.S. and Canada – Mead Johnson (of Enfamil), Abbott (Similac) and Nestle (Gerber Good Start). Participants are urging the companies to end the unethical practice of promoting formula in health care facilities, particularly through the distribution of commercial discharge bags with formula samples – a longstanding violation of the code.

Mothers and leaders are delivering a petition with more than 17,000 signatures to Mead Johnson at its headquarters outside of Chicago. The petition will also be presented to Abbott and Nestle. Thousands of others are taking action remotely, sending photos and messages to companies on Facebook, Twitter and other online platforms. A diverse group of consumer rights, public health, women’s health, corporate accountability and breastfeeding advocacy organizations are co-sponsoring the effort. The day of action is not meant to advocate against formula use if necessary but to focus on the need to give mothers information that hasn’t been influenced by formula companies.

Most health care professionals and the American Academy of Pediatrics recommend that mothers exclusively breastfeed for six months. A large body of research shows that antibodies passed from a nursing mother to her baby can help lower the occurrence of many conditions among infants including ear and respiratory infections, diarrhea, meningitis and higher risks of allergies, sudden infant death syndrome and other health risks. Mothers also benefit, with a reduced risk of type 2 diabetes, breast cancer, obesity, ovarian cancer, post-partum depression and bladder infections.

Public health experts overwhelmingly discourage hospitals and doctor’s offices from distributing formula company-sponsored gift bags and formula samples – common marketing tactics – but formula companies still find ways to market formula in facilities nationwide. Studies show such formula sample distribution undermines women’s breastfeeding success because the practice is viewed as an endorsement of formula by health care providers. In 2011, then-U.S. Surgeon General Regina A. Benjamin called for more enforcement of the WHO Code through the Baby-Friendly Hospital Initiative, which requires designated hospitals to comply with the code.

Nearly half of the world’s countries have adopted legislation to implement the Code, but in the U.S. — as a result of formula industry lobbying and political influence— legislation currently remains out of reach.

But advocacy efforts have led many hospitals to end formula promotion over the past decade. According to the Centers for Disease Control and Prevention (CDC) Maternity Practices in Infant Nutrition and Care (mPINC) surveys, 27.4 percent of hospitals had discontinued the formula discharge bags for breastfeeding mothers in 2007, and by 2011, 45.5 percent had ended the practice. All hospitals in Massachusetts and Rhode Island have voluntarily banned discharge bags, and a recent Public Citizen and Ban the Bags report found that 82 percent of the U.S. News and World Report’s top-ranked hospitals, and more than two-thirds of the highest ranked hospitals in gynecology, no longer hand out commercial formula discharge bags with samples. However, formula companies have increasingly managed to push formula samples in doctor’s offices and clinics, often without the knowledge of health care providers within those offices.

Diverse organizations are co-sponsoring the day of action with Public Citizen. They include the U.S. Breastfeeding Committee (composed of more than 50 member organizations), the Best for Babes Foundation, Food and Water Watch, Corporate Accountability International, the National Women’s Health Network, Our Bodies Ourselves, La Leche League USA, HealthConnect One, the National Alliance for Breastfeeding Advocacy, the California WIC Association, Power U Center for Social Change, Breastfeed Chicago, the Chicago Region Breastfeeding Task Force, the Massachusetts Breastfeeding Coalition, the North Carolina Breastfeeding Coalition, the Coalition of Oklahoma Breastfeeding Advocates, the Pennsylvania Breastfeeding Coalition, the New York State Breastfeeding Coalition, United States Lactation Consultants Association and Women Empowered Systems Enrichment (WISE).

To learn more about the Public Citizen’s campaign to stop infant formula marketing in health care facilities, visit http://citizen.org/infant-formula.

Eva Seidelman is a Researcher for Public Citizen’s Commercial Alert.


by Ashley Bender

Lobbying by corporate giants may have succeeded in swaying a powerful government agency from changing an outdated, expensive payment system that wastes taxpayer dollars on bloated corporate profits. And, while the industry did pay $8 million on its lobbying effort to prevent the changes, the annual future corporate return on the effort is projected to be as much as 100 times ($800 million) the lobbying cost.

The United States Government and Accountability Office found that Medicare overpaid dialysis treatment centers for services administered to seniors by between $650 and $800 million in 2011. Most of the overpayment went to two large corporations, DaVita HealthCare Partners Inc. and Fresenius Medical Care AG, which together control a majority of the dialysis center market.

To mitigate the gross overpayment to dialysis treatment centers, the Centers for Medicare and Medicaid Services (CMS) proposed to reduce future payment rates for expensive anemia drugs and other dialysis center services by a total of 9.4 percent for calendar year 2014. Reducing Medicare payments to dialysis centers Medicare would save an estimated $4.9 billion over the next ten years, according to the Congressional Budget Office. But the healthcare giants were able to convince more than 100 members of Congress to oppose the proposed CMS rule and suggest that the Obama administration either reverse the spending cuts or dramatically water down the spending cut proposal.

On Friday, November 22, CMS released a press statement acquiescing to the wishes and pressures of the health care corporate titans. In the end, CMS’ policies remain virtually unchanged. Rather than cutting reimbursement payments to dialysis centers by 9.4 percent, the payments will be kept essentially flat between the 2013 reimbursement rates and the 2104 reimbursement rates. Dialysis treatment centers will continue to be overpaid, and DaVita HealthCare Partners Inc. and Fresenius Medical Care AG will continue to reap hundreds of millions of excess taxpayer dollars.

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a photo of Rick Claypool, online director for Public Citizen's Congress WatchThe corporate right wing is unleashing one of its more tired ploys in an attempt to smear our campaign to stop corporations from secretly distorting elections via front groups and shell companies.

The ploy is to label a policy proposal as “too partisan,” regardless of how much broad bipartisan support it has.

Then repeat.

And then repeat (ad nauseam).

In this case, we’re talking about a Securities and Exchange Commission (SEC) rule to require corporations to disclose their political spending, a reform supported by 77 percent of Americans across the political spectrum, and 91 percent of recently surveyed business leaders.

Rep. Darrell Issa (R-Calif.), chair of the powerful House Oversight Committee, issued a missive calling on the SEC to ignore Public Citizen and the more than 600,000 people (many of whom are investors) who have called on the SEC to bring corporate dark money into the light.

The Issa missive specifically mentioned Public Citizen. Here are a few examples:

“… Public Citizen … is spearheading outside efforts to pressure the SEC to adopt a political disclosure rule.”

We can’t take all the credit, but thanks for noticing our hard work.

“… Public Citizen, a group with a history of calling for investigations of groups organized under section 501(c)(4) …”

Issa means 501(c)(4) groups like Karl Rove’s Crossroads GPS. Guilty as charged – with pride.

Public Citizen has a history of demanding that the IRS and the FEC investigate tax-exempt groups.”

To protect taxpayers by making sure our tax dollars don’t wind up subsidizing partisan corporate propaganda? Absolutely.

Issa’s intention seems to be to insinuate something unseemly about transparency about corporate political spending.

But the fact is that secret corporate spending is a tremendous problem for both the general public and for investors.

As a result of the U.S. Supreme Court’s reckless ruling in Citizens United v. Federal Election Commission, corporations can keep their political spending secret simply by funneling their political dollars through trade groups like the U.S. Chamber of Commerce and dark money outfits like Karl Rove’s Crossroads GPS.

Union members can look up filings with the Labor Department to find out how their labor organization is spending money in politics. Residents of areas being blasted with super PAC ads can conduct research to find out who is behind them.

Why should the likes of Walmart, Exxon Mobil, Bank of America and Monsanto be allowed to spend in secret?

We don’t think they should – and neither do most Americans.

The issue of transparency of corporate political spending is neither a partisan issue nor a special interest issue.

It is a public interest issue, and one we proudly support.

Want to be involved?

Join the more than 600,000 people who have called on the SEC to disclose corporate political spending.

Rick Claypool is online director for Public Citizen’s Congress Watch division. Follow him on Twitter at @RickClaypool.

BRCA gene

Co-authored by Adriana Benedict and Tiffany Jang

The U.S. Patent and Trademark Office (USPTO) and European Patent Office (EPO) have been granting patents on isolated human DNA since the early 1980s.  Many countries have followed their lead.

More than three decades later, the U.S. has become the first country to reject the patent eligibility of isolated DNA following last week’s Supreme Court ruling in Ass’n of Molecular Pathology v. Myriad Genetics.  Will its opinion have any global ripple effects?

The USPTO has promoted harmonization with its standards of patentability through training and technical assistance programs since 1985.  USPTO patent standards have spread in part due to a partnership established between the USPTO, EPO and Japanese Patent Office (JPO) in 1983.  As noted by the Australian Law Reform Commission, in 1988, these Trilateral Offices issued a joint statement explaining that

Purified natural products are not regarded as products of nature or discoveries because they do not in fact exist in nature in an isolated form. Rather, they are regarded for patent purposes as biologically active substances or chemical compounds and eligible for patenting on the same basis as other chemical compounds.

In response to some uncertainty regarding claim drafting for isolated DNA sequences, the USPTO Manual of Patent Examination and Procedures was updated in 1990 to provide clear guidelines to this effect. Similarly, the JPO’s Implementation Guidelines for Inventions in Specific Fields explicitly provides that isolated genes are patentable; and in the E.U., isolated DNA is patentable under Biotechnology Directive 98/44/EC (although patents on isolated DNA may only be issued in the E.U. if the inventor can show that the genetic sequence exhibits surprising or unexpected properties).  Importantly, the European Commission was influenced by the U.S.’s acceptance of gene patents in its deliberations leading up to the directive.  When it proposed the Biotechnology Directive in 1988, it noted:

[W]hereas the two leading nations in biotechnology, the United States of America and Japan, have been able continuously to adapt their patent protection according to the latest needs of industry, science and consumers, the Member States, representing comparable potential of intellectual manpower and capital, are immobilized by a not yet completed and . . . outdated legal framework.

Other countries have followed suit.  Isolated DNA sequences are patent eligible in Canada as biomolecules, and the Intellectual Property Office of Singapore recognizes patents on genes, in accordance with Howard Florey Institute [Relaxin].  In February of this year, the Federal Court of Australia held that isolated DNA is patentable under the Statute of Monopolies because it embodies a chemical compound, and thus is a “manner of manufacture,” rather than genetic information.

But the Supreme Court is forcing the USPTO to reverse course. In the long-awaited Myriad opinion, the U.S Supreme Court ruled late last week that isolated human DNA is not patentable subject matter because it is naturally ocurring, while complementary DNA (cDNA) is patentable subject matter because it is not naturally occurring. cDNA is a synthetic form of DNA that does not contain introns (nucleotide sequences that don’t encode for proteins), while isolated DNA is composed of exons (protein-coding nucleotide sequences) interspersed with introns.  Because both isolated DNA and cDNA have important research applications, the Supreme Court’s decision in Myriad will have an enormous impact on the future of biotechnology, biomedical research, and diagnostic and therapeutic efforts.

Prior to Myriad, the recognition of human genes as patentable subject matter meant that the owners of patents on isolated DNA could hold monopolies on the genetic information embodied in DNA sequences, raising the cost of access to this information for both patients and scientific researchers. This led to a concern that, among other things, exclusively licensed patents on isolated DNA stood in the way of patient access to secondary opinions confirming the results of genetic tests.  To address this concern, the America Invents Act had directed the USPTO to explore this challenge and propose possible solutions to it; the USPTO’s final report, however, was delayed more than a year and has yet to be released.   

Under common law precedent regarding 35 U.S.C. § 101’s definition of patentable subject matter, laws of nature, products of nature and abstract ideas cannot be patented in the U.S.  As explained in Mayo v. Prometheus, laws of nature constitute “the basic tools of scientific and technological work.”  In addition to playing a major role in the Supreme Court’s ruling in Mayo last year, the law of nature exception has a long history of Supreme Court precedent, including Mackay Radio & Telegraph Co. v. Radio Corp. of America, Funk Bros. Seed v. Kalo Inoculant, and Parker v. Flook.  Indeed, even in Diamond v. Chakrabarty, the case considered to have paved the way for gene patents, the Court expressly stated that “laws of nature, physical phenomena, and abstract ideas have been held not patentable.”  Prior to today’s ruling, it was the long-held practice of the U.S. Patent and Trademark Office (USPTO) to grant patents on isolated DNA. It had been widely believed that because human DNA does not exist in nature in isolated form, isolated DNA could be patented on the grounds that it is a product of human ingenuity.

Petitioners in Myriad challenged the legality of Myriad’s patents on BRCA1 and BRCA2 genes, mutations of which are known to be associated with heightened risk of breast and ovarian cancer. Myriad’s patents on isolated DNA had originally been struck down by the Southern District of New York in a ruling that was later reversed and subsequently affirmed after being remanded by the Supreme Court.  In a unanimous holding (with the exception of some minor concurrences by Justice Scalia on biological explanations), Justice Thomas explained that isolated human DNA is not patent eligible subject matter under § 101 because it constitutes a law of nature.  Specifically, the Court explained that:

  1. Myriad did not invent anything by isolating or locating the BRCA1 and BRCA2 genes, but rather identified what already exists in nature;
  2. the relevant “patent descriptions simply detail the ‘iterative process’ of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought;
  3. the claims at issue cover the information contained in a genetic sequence rather than chemical compositions themselves; and
  4. deference to past USPTO practice was not persuasive in the absence of explicit statutory support for the patentability of isolated genes, which is absent from Title 35 of the U.S. Code.

In contrast, the Court explained that cDNA—with the exception of very short strands free from intervening introns—is patentable because it differs from naturally occurring DNA, which contains both introns and exons.

Myriad paves the way for increased competition in the provision of genetic tests for BRCA1 and BRCA2 mutations because Myriad will no longer have a monopoly on all research and diagnostic methods that use the isolated BRCA1 and BRCA2 nucleotide sequences.  On the coattails of the Court’s ruling, many diagnostic companies and research institutions such as Ambray Genetics and the University of Washington announced their intentions to incorporate BRCA1 and BRCA2 into their next-generation sequencing panels, significantly reducing the cost of BRCA1 and BRCA2 diagnostic testing.  Similarly, GeneDX has announced its plans to launch comprehensive genetic testing for hereditary cancers, and DNATraits has said that it will provide a test for $995, less than a third of the cost of Myriad’s test. There has also been speculation that whole genome sequencing will become easier without Myriad’s patents on isolated BRCA1 and BRCA2 sequences. However, Myriad will retain its monopoly over BRCA Analysis, the only test currently used worldwide for determining susceptibility to hereditary breast and ovarian cancer based on an analysis of BRCA1 and BRCA2 mutations.  Additionally, Myriad will retain a monopoly on all research that involves the cDNA of BRCA1 and BRCA2, which includes many research methods that use a probe to assay for gene expression.

Following in the footsteps of Mayo v. Prometheus and Bilski v. Kappos, Myriad is the third case since 2010 in which the Supreme Court has used subject matter eligibility to limit long-standing practice of the USPTO.  This apparent trend demonstrates the risk in exporting the maximum reach of U.S. law and practice at any given time via the USPTO and trade agreements negotiated by the office of the U.S.  What is clear for now, however, is that the Supreme Court is scaling back on the maximalist tendencies of U.S. patent policy, referred to by some as the global IP ratchet.

Will other countries once again follow suit?

 

 

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