Archive for the ‘Pharmaceuticals’ Category

fda approved smallNo one can dispute that multidrug-resistant “superbugs” are a key public health concern for the 21st century. Better, safe and effective cures are needed. But the 21st Century Cures Act, legislation that will be voted on this week in the House, is not the solution to this problem.

Over 2 million people are infected with antibiotic-resistant bacteria each year, resulting in at least 23,000 deaths. New antibiotics have been slow in coming: No antibiotic with a truly novel mechanism of action has been discovered since the late 1980s. Yet this drought is not the fault of the Food and Drug Administration (FDA), which has long been under tremendous pressure to approve new antibiotics quickly. This pressure was increased even further by a 2012 law that accelerated review for qualifying antibiotics.

Thanks to the current review process for antibiotics, clinical development for these drugs is already quick by industry standards. A new antibiotic takes only seven years to get to market, compared with nine years for cancer drugs.

Quick approval is not without costs. Many of the antibiotics approved over the past decade have suffered from safety and effectiveness problems. For example, tigecycline (Tygacil), an antibiotic that received special accelerated FDA approval in 2005, was slapped with a black-box warning in 2013 stating that the drug increases the risk of death.

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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.

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