Why is This a Model America Wishes To Emulate?

You should never trust Big Pharma to protect your interest. They are for profit organizations, to make money. Unfortunately, some have gone overboard and sold their souls to mammon.

— Matthew Day, Telegraph, Reporter

The medical staff, including three Polish doctors and six nurses from the northern town of Grudziadz, are being investigated over medical trials in which homeless and poor people who died last year. Prosecutors say the medical trial involved an untried vaccine to the highly-contagious H5N1 bird-flu virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

The director of a Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that last year, 21 people from his centre alone, died, a figure well above the average annual flu deaths of about eight.

Although authorities have yet to prove a direct link between the deaths and the activities of the medical staff, Poland’s health minister, Ewa Kopacz, has said that the doctors and nurses involved should not return to their profession.

“It is in the interests of all doctors that those who are responsible for this are punished,” the minister added. Investigators are also probing the possibility that the medical staff may have also have deceived the pharmaceutical companies that commissioned the trials.

The suspects said that the all those involved knew that the trial involved an anti-H5N1 drug and willingly participated.

The news of the investigation will come as another blow to the reputation of Poland’s beleaguered and poverty-stricken national health service. In 2002, a number of ambulance medics were found guilty of killing their patients for commissions from funeral companies.

©2012 An Inconvenient Woman. All Rights Reserved.

Last month, Jim Edwards of BNET PHARMA revealed how much cash is involved to influence the outcome of the Obama Healthcare Reform bill. Big Pharma Lobbying Bucks are raining down on Washington. Congressional representatives and members of the Obama administration have to at least consider the Industries requests…after all, Big Pharma, at $1.6 billion since 1998, represents the number ONE all-time spender on lobbying.

If, and when, any of our elected representatives, actually reads the Health Reform Bill being pushed through by Madam Speaker, Pelosi, they’ll probably find Big Pharma wish list items like:

• Pharmaceutical and health product companies, like the insurance industry, strongly oppose any proposal to create a public health insurance option, fearful that private insurers would be marginalized and government price controls would limit what the industry can charge for its products.

• Medicaid, which provides insurance to poor families, expanded to cover more low-income workers. This would mean more people could afford drugs and medical devices, increasing the industry’s target market.

• Big Pharma supports the mandate that all Americans purchase health insurance, boosting the industry’s customer base by millions.

If and when, The Obama Administration keeps its promise to post the Health Care Reform Bill on the Internet for public review, be an example to the Congress read it; discuss it; make suggestion to your representative. Who knows maybe your rep is one that care more about representing view of the folks that voted for him, the Big Pharma lobbyists that donate big bucks to his favorite charity, or offered his wife a job.

As President Obama waits for Congress to deliver a heathcare reform bill, pharmaceutical companies are spending millions on lobbyists to thwart any measure that might make drug prices cheaper or even allow the government to negotiate them, according to the Center for Responsive Politics.  Companies spent 41 percent more this year on lobbying than last, USA Today reported.

A look at company lobbying reports by the Associated Press shows companies aligned in lockstep against price controls, allowing Medicare and Medicaid to negotiate prices, or drug reimportation.

And companies have laden Congress members with campaign donations, funds to their non-profits, and paid seats on their boards. Taken together, it looks like Congress is bought and paid for. Thus millions of Americans may be entertaining a false hope that Washington will deliver a plan that will lift U.S. healthcare out of its Third World status and into something approaching modernity, like Europe or Canada. An example, from The Boston Globe:

The wife of Senator Chris Dodd, who is in charge of writing the Senate’s bill, sits on the boards of four healthcare companies.

Many other lawmakers own thousands in stock or recieve more in compensation to sit on pharma company boards. The Washington Post has a comprehensive list of money ties between congressmen and drug companies:

Almost 30 key lawmakers helping draft landmark health-care legislation have financial holdings in the industry, totaling nearly $11 million worth of personal investments in a sector that could be dramatically reshaped by this summer’s debate.

And a USA Today report details how drug companies keep politicians’ pet charities funded:

Health care groups, for instance, give millions to the planned Edward M. Kennedy Institute for the United States Senate in Boston. Pharmaceutical giant Amgen wrote the biggest check — $5 million in December — to the institute, which will honor Kennedy’s more than four decades in Congress and promote the study of the U.S. Senate.

Here, compiled by the AP, are individual company details about the lobbying activities in Q1 2009:

• PhRMA – $7 million
  PhRMA is again trying to ensure drug companies won’t face steep cuts in prescription prices and, instead of reducing drug margins, have proposed cost reductions to hospitals and insurers.
• Pfizer – $6.1 million
  Pfizer … more than doubled its lobbying spending from the year-ago period. The company also spent nearly $3.3 million lobbying in the fourth quarter of 2008.
  New York-based Pfizer lobbied on legislation on health reform initiatives, electronic prescriptions, veterans issues, allowing generic versions of expensive biologic drugs and a proposal requiring research comparing the effectiveness of different medical treatments.
  It also lobbied on U.S. patent reform and on international patent, trade and regulatory issues involving more than 20 countries; national health insurance; legislation to require drug makers to disclose payments to physicians; reauthorization of the State Children’s Health Insurance Program; and environmental issues related to pharmaceutical manufacturing.
• Eli Lilly – $3.4 million
  Domestically, the drugmaker lobbied on Medicaid rebates and advertising transparency.
• Amgen – $2.8 million
  Amgen Inc., the world’s largest biotechnology company, spent nearly $2.8 million lobbying in the first quarter as Congress debates a potential system for bringing less expensive copies of pricey biotech drugs to the market.
• Merck – $1.5 million
  Merck lobbied Congress and the White House on health care reform issues including increasing coverage for uninsured people, requiring research comparing the effectiveness of different medical treatments and keeping a private-sector health care system.
  … and increasing funding for the national immunization program for low-income children.
  Merck lobbied against imposing government price controls on prescription drugs bought under the Medicare program and against expanding rebates paid to the government for medications bought under the Medicaid program. But it lobbied for ensuring access to vaccines under Medicare; it sells the Zostavax vaccine against shingles, a painful, blistering rash that generally strikes senior citizens.
• Johnson & Johnson – $1.5 million
  It lobbied on multiple bills involving the Medicare prescription drug program that would either limit discounts given to the government or lower the prices it pays.
  J&J which offers employee wellness programs, lobbied in support of a tax credit to employers who do so, and on a bill that would require drug and medical device makers to report many payments to physicians.
• Wyeth – $876,000
  Madison, N.J.-based Wyeth  ( WYE -  news  -  people ) lobbied on several aspects of health care reform, including bills that could limit the prices the government pays for medications, as well as public disclosure of drugmaker payments to doctors. It lobbied on drug advertising rules and legislation to modernize the Food and Drug Administration.
  The maker of Centrum vitamins also lobbied on dietary supplement issues.
• Schering-Plough – $600,000
  Schering-Plough lobbied on health reform issues including access to coverage, price rebates for drugs bought under the Medicaid program and proposals to require research comparing effectiveness of different medical treatments.
  The maker of allergy treatments Nasonex and Claritin, and the HomeAgain Pet Recovery System also lobbied on reauthorization of the Children’s Health Insurance Program, legislation affecting Food and Drug Administration operations, and against importation of cheaper prescription drugs from foreign countries, which domestic drugmakers have opposed for years.
• Amylin – $350,000
  San Diego-based Amylin lobbied on legislation that would allow the Food and Drug Administration to approve copies of biotech drugs, reimbursement issues, drug safety and physician payment disclosures.
• Biogen – $290,000
  The Cambridge, Mass.-based company lobbied on legislation that would set up a process for the Food and Drug Administration to approve biosimilars, or copies of biotech drugs.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University’s business and journalism schools.
Email Jim Edwards or follow him on Twitter.

BNET Pharma provides daily industry news coverage and insights for managers and executives about the major manufacturers of pharmaceuticals and medicine. In addition to detailed company profiles, we bring you critical analysis on new alliances and partnerships, new patents and products, mergers and acquisitions, cost management, investments and deal flow, and a host of other important business issues.

Image by Flickr user AMagill, CC

©2012 An Inconvenient Woman. All Rights Reserved.

I thought Nick’s response warranted reposting here. In the spirit of full disclosure, Nick Batik is my husband and partner in Pleiades Publishing Services and the designer of the Iconic Woman and  Holy Hormone sites.

Gardasil, By The Numbers

I view the question of Gardasil more from and economic prospective:

US 2000 Census places girls age 10-14 at 6.9% of the total female population of 151,627,727.
That would be 10,462,313 girls.

Gardasil is currently on the market for $120 per single dose. Three doses are required over a 6-month period, making the total cost for the HPV vaccine $360. On top of that, some doctors are charging office visit fees when the vaccine is given.

That would be a total expenditure of $3,766,432,680 not including office visits. In your article you state that 11,070 cases of cervical cancer were reported in the US. Assuming that 100% of those could be prevented by Gardasil (which it cannot – it only affect 4 of the 72 variations) that would be a cost per case of $340,238.

If you look at the 11,070 reported cases, 3,870 resulted in death. If you measure the cost of Gardasil based on the lives saved (again assuming 100% save rate), that would be $973,238 spent per life. It should be noted that 7,200 (65%) did not die, and that had nothing to do with Gardasil.

Recent congressional reports indicate that an increasing number of cancer related deaths are due to “lack of access” to health care, as opposed to the failures of current treatments. The relatively high cost of the vaccine is just as much a barrier to the poor and uninsured – those most at risk.

The World Health Organization states that there are a number of low-cost, highly effective diagnostic screening options (e.g. PAP test – avg. $27 USD*) and that cervical cancer is one of the most treatable (with access to health care).
*NOTE:  Using PAP Test Recommended guidelines for most women from:
http://www.womenshealth.gov/faq/pap-test.cfm#pap04

• If you are younger than 30 years old, you should get a Pap test every year.
• If you are age 30 or older and have had 3 normal Pap tests for 3 years in a row, talk to your doctor about spacing out Pap tests to every 2 or 3 years.
• If you are ages 65 to 70 and have had at least 3 normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.

It would be a reasonable expectation for a woman to have 25 PAP test throughout her lifetime. At $27 USD per test, a woman would invest $675 USD for a life time cervical cancer prevention plan.

Lets be real clear here — even with the Gardasil HPV vaccine the current medical direction is to continued with your regular PAP test schedule. So why risk the possible side effects of the vaccine?

One great unanswered question: increasing outbreaks of diseases though to be eradicated or under control has shown that the efficacy of inoculations given to school age children diminishes over time. Since cervical cancer does not manifest in most women until after age 40, will the Gardasil treatment still be effective, or will it need to administered again?

Considering the number of high-death rate diseases, is this REALLY the best use of our limited health care resources?

Resources:
http://factfinder.census.gov/servlet/STTable?_bm=y&-geo_id=01000US&-qr_name=ACS_2007_3YR_G00_S0101&-ds_name=ACS_2007_3YR_G00_

©2012 An Inconvenient Woman. All Rights Reserved.

Merck’s continued looting of state and federal public health budgets for a dangerous and unnecessary vaccine is unsustainable and has to stop.

There are better, safer, more sustainable ways to prevent and treat cervical cancer both at home and in developing countries.  Safety, and ethical issues aside, as a country, we simply cannot afford the Merck solution. There are too many other critical demands for public and private health dollars.

In early 2006, when I first started writing about Gardasil, I questioned the necessity of a very expensive, possibility unsafe vaccine for a disease that was easily detected through the use of regular PAP screens and was the most treatable and curable of all cancers. According to the American Cancer Society, fewer than 4,000 lives are lost annually to cervical cancer in America. These women, precious mothers, sisters, daughters, all, could have been saved with affordable access to PAP tests. The logical answer to me was finding a way to get low income and new immigrant populations into neighborhood clinics… problem solved, women and girls did not need Gardasil.

The “500,000-Cervical Cancer Deaths” Merck touted in their marketing blitzkrieg as their HPV vaccine’s justification, referred to women in developing countries who died due to inadequate access to existing medical solutions.

Convinced that Merck’s HPV vaccine, the $400 per series  Gardasil, was simply not appropriate technology for the existing threat, I also reported on the Alliance for Cervical Cancer Prevention (ACCP) work with ‘Visual Inspection with Acetic Acid (VIA) as a low cost, easily deployable, alternative to the PAP Smear.

For middle-aged women in the developing world, cervical cancer is one of the leading causes of death. Cervical cancer is almost completely preventable, if precancerous lesions are identified and treated in a timely manner. Cervical cancer screening based on cytological examination is largely unavailable in developing countries or, made available to a small, select group of women in private facilities, maternal child health sites, or family-planning clinics, missing the age groups at highest risk for precancerous lesions.

Visual inspection with acetic acid (VIA) can be used to screen women. It can be done by nurses or midwives with appropriate training. Research results show that VIA is simple, accurate, cost-effective, and acceptable to most women. Visual inspection with acetic acid (VIA) can be done with the naked eye (also called cervicoscopy or direct visual inspection [DVI]), or with low magnification (also called gynoscopy, aided VI, or VIAM).  VILI, another variation of the visual inspection, known as Schiller’s test, uses Lugol’s iodine.

Various world health organizations and charities have been actively deploying VIA solutions in Latin America, Africa and India since the late 1990’s. By 2002 and 2003 promising results had been reported. For a very, low cost, (under $20) cervical cancer was being detected and treated successfully. When the BIG FOOT of Merck can crashing down, it lobbied for funds previously committed to more sustainable technologies.

Could the millions Merck wheedled from the Bill and Melissa Gates Foundation for doses of over-priced, possibly unsafe, vaccines be more effectively allocated? In my opinion — Yes!

As healthcare dollars become scarcer, all of us are going to ask, “What is sustainable? What solution will help the greatest number of people, affordably? What is the least invasive solution, with least opportunity for harmful side effects?”

When public health officials and medical practitioners start asking those hard questions, Merck’s HPV vaccine, Gardasil will not be the objective answer.

ACCP partner organizations in ongoing VIA research are: EngenderHealth ; International Agency for Research on Cancer (IARC);  JHPIEGO; Pan American Health Organization (PAHO);   Program for Appropriate Technology in Health (PATH)

Sources: Evaluation of visual inspection with acetic acid (VIA), Lugol’s iodine (VILI), cervical cytology and HPV testing as cervical screening tools in Latin America : this report refers to partial results from the LAMS (Latin American Screening) study
http://repositorium.sdum.uminho.pt/handle/1822/4033

Test characteristics of visual inspection with 4% acetic acid (VIA) and Lugol’s iodine (VILI) in cervical cancer screening in Kerala, India.
Sankaranarayanan R, Wesley R, Thara S, Dhakad N, Chandralekha B, Sebastian P, Chithrathara K, Parkin DM, Nair MK.

International Agency for Research on Cancer, 150 cours Albert Thomas, Lyon 69008, France. sankar@iarc.fr
http://www.ncbi.nlm.nih.gov/pubmed/12845681

Cervical cancer screening in low resource settings using visual inspection with acetic acid. Carr KC, Sellors JW. Seattle University, College of Nursing, Seattle, WA 98122, USA. Kcarr@seattleu.edu
PMID: 15236713 [PubMed – indexed for MEDLINE

©2012 An Inconvenient Woman. All Rights Reserved.

Kathleen Slattery-Moschkau, filmmaker, talk radio host and  commentator, laid out Big Pharma’s marketing mission in a brilliant article, ‘Pharma: Still Chasing Skirts’, posted on March 13, 2009 to HuffingtonPost.com.

Kathleen Slattery-Moschkau spent ten years inside the pharmaceutical industry and can state one thing for sure: Big Pharma goes where the money is — and the money is with the women of our nation. Although women are certainly not the only targets of drug ads, winning the female audience is critical to the success of any given drug. Women are more proactive about their health, more likely to “talk to their doctor”, more likely to encourage their husbands to seek medical treatment, and more likely to manage the healthcare for the entire family. It is just darned good business for pharma to set their sights on the ladies. But what is good for business — explosive prescription sales of new drugs — is not necessarily good for public health.

This is a great article, pass it on to your friends.

For the full article go to: Pharma: Still Chasing Skirts

©2012 An Inconvenient Woman. All Rights Reserved.

Reported by David Jolly

With the purchase, Merck is expanding its franchise in cardiovascular, respiratory and oncology drugs and shoring up its research pipeline, in particular with a Schering-Plough product called TRA, a promising drug designed to prevent blood  clotting.

In addition, Merck will benefit from the worldwide reach of Schering- Plough, which generates about 70 percent of its sales outside the United States, including more than $2 billion in annual revenue from emerging markets.

The companies said in a joint statement that the merged company would keep the name Merck and that the deal had been unanimously approved by their boards. Richard Clark, Merck’s chairman and chief executive, will lead the combined company.

The deal is the second major pharmaceutical deal this year after Pfizer, the world’s biggest drug maker, agreed in January to pay $68 billion for Wyeth. And Roche, the Swiss pharmaceutical company, is pursuing a full acquisition of the California biotechnology company Genentech, in which it already owns a majority stake.

Merck is among the drug makers that face the hardest time in the next decade because of patent expirations, said Richard Purkiss, a drug sector analyst at Atlantic Securities in London. Most pressingly, it faces the expiration in 2012 of the patent on Singulair, the asthma drug that is its top-selling product.

In contrast, “Schering- Plough doesn’t have much exposure to patent expiries in the same time frame,” he said. “This is really about combining to protect earnings.”

Shares of Schering- Plough rose more than 8 percent Friday amid speculation that the company had been pursuing a deal with either Merck or Johnson & Johnson, with which it jointly produces the arthritis drug Remicade.

Under the terms of the agreement announced Monday, Schering-Plough shareholders will receive 0.5767 share of the combined company and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Based on Merck’s closing stock price Friday, the deal values Schering-Plough at $23.61 ar share, or $41.1 billion, a premium to Schering-Plough shareholders of about 34 percent.

The 44 percent of the deal that is being paid in cash will include $9.8 billion from existing cash balances and $8.5 billion from financing provided by JPMorgan Chase.

Merck shareholders will own about 68 percent of the merged company, and Schering-Plough shareholders will own the rest. Merck said it expected the deal to contribute “modestly” to its earnings in the first year and “significantly”  thereafter.

“We are creating a strong, global health care leader built for sustainable growth and success,” Clark said in the statement. “The combined company will benefit from a formidable research and development pipeline, a significantly broader portfolio of medicines and an expanded presence in key international markets, particularly in high-growth emerging markets. The efficiencies we gain will allow us to invest in strategic opportunities, while creating meaningful value for  shareholders.”

The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public company.

Merck said it expected annual cost savings of about $3.5 billion after 2011. The savings “are expected to come from all areas across the combined company and from the full integration of the Merck/Schering-Plough Pharmaceuticals cholesterol joint venture,” it said, and are in addition to previously announced cost-cutting measures at the two companies.

David Moskowitz, an analyst at Caris & Co. in New York, suggested that the companies might have to raise the offer price above $23.61.

“I think it should be at least $12 billion to $15 billion higher,” he told Reuters, as investors might not be happy until the price reaches “the high $20s or $30″ a share.

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Levine filed a lawsuit against Wyeth in state court in Vermont over alleged problems with the Phenergan label, and a jury ruled in her favor. The Vermont Supreme Court upheld the decision. In an appeal to the U.S. Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels (Kaiser Daily Health Policy Report, 10/3).

The current Supreme Court — “one of the most pro-business ones in 50 years,” according to the Journal — in February ruled in favor of pre-emption in a case involving the medical device company Medtronic. In addition, Justice Stephen Breyer in a “testy burst” during a recent drug-related case asked the plaintiff’s lawyer whom she would rather have in charge of whether drugs should be allowed on the market: “an expert agency, on the one hand — or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt, and don’t see those who need the drug to cure them?” According to the Journal, the Bush administration “has long promoted the idea that federal law pre-empts state lawsuits.”

Comments

Wyeth officials noted that the suit does not allege that the firm knowingly sold a dangerous product and that it complied with FDA guidelines for the drug’s label. In addition, Wyeth officials said that strengthening the label to comply with stricter Vermont law would have been a violation of federal law. Bert Rein, lead outside attorney for Wyeth, said, “It would be a chaotic system if you can relabel anything as long as you mumble safety.” However, Rein said he did not know of any instances where FDA had punished a firm for increasing the emphasis of a warning label.

Levine’s lawyers say federal law is not intended to prevent drugmakers from taking proactive steps to enhance warnings to doctors and consumers. According to the Journal, they say FDA guidelines “are the floor, not the ceiling, when it comes to safety standards.”

Consumer advocates say patients’ ability to sue in state courts is their only defense against corporate misbehavior, such as instances where FDA reviewers make a mistake or firms hide information. The New England Journal of Medicine in August published an editorial in favor of Levine that made similar arguments. Rein said that a ruling in favor of pre-emption would make it more difficult for people harmed by drugs to obtain compensation, but noted that Congress should establish a fund for such patients, as it did for vaccine-related injuries.

Implications

According to the Journal, a ruling in favor of pre-emption could heavily affect the drug industry. Recent cases that would have been affected include a $68 million settlement by Johnson & Johnson over its Ortho Evra contraceptive patch, more than $1 billion in settlements by Eli Lilly over its antipsychotic drug Zyprexa and $4 billion in payments so far by Merck over lawsuits involving its anti-cholesterol treatment Vioxx.

The Journal reports that some Democrats said that if they increase their majority in Congress this election cycle they will propose bills to undo pre-emption and guarantee the ability of patients to sue for damages (Wall Street Journal, 10/27).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

The Environmental Protection Agency is poised to rule that it will not set a drinking-water safety standard for perchlorate. This component of rocket fuel has been linked to thyroid problems in pregnant women, newborns and young children across the nation.

The story broke last week in a number of major newspapers; but was pushed to the back pages by the looming “debt-bomb” about to dropped on the taxpayers in the name of friendly fire from our elected representatives. No one in good conscious could refer to anyone in Washington, of any political stripe, as “leaders”, but that is another story for another day.

The EPA’s “preliminary regulatory determination” estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe. Independent researchers, using federal and state data, have put the number at 20 million to 40 million.

Most perchlorate contamination in U.S. drinking water is the result of improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required. The Government Accountability Office reported this spring that the Pentagon had pressured the EPA for several years not to regulate perchlorate.

“They have distorted the science to such an extent that they can justify not regulating” the chemical, said Robert Zoeller, a University of Massachusetts professor who specializes in thyroid hormone and brain development and has a copy of the EPA proposal. “Infants and children will continue to be damaged, and that damage is significant.”

Zoeller said scientific studies have shown that a small reduction in thyroid function in infants can translate into a loss of IQ and an increase in behavioral and perception problems. “It’s absolutely irreversible,” he said. “Even small changes in thyroid functions early on have impacts on functioning through high school and even into people’s 20s.”

According to a Washington Post article, OMB officials deleted any references to those studies in the EPA’s proposal.

The current EPA document states that establishing a drinking-water standard for perchlorate “would not present a ‘meaningful opportunity for health risk reduction for persons served by public water systems,’ ” but it also reveals that many Americans will be exposed to the compound at levels higher than recommended if nothing is done to remove it. Perchlorate impedes the functioning of the thyroid gland, which produces hormones that foster mental and physical development and control metabolism. The notice indicates that the agency plans to finalize its decision by December 1st, 2008.

In response to the “dust-up” over the preliminary report, the EPA’s assistant administrator for water, Benjamin H. Grumbles, stated; “Science, not the politics of fear in an election year, will drive our final decision.”

“Until then, final numbers and strategies are mere speculation,” Grumbles added. “We know perchlorate in drinking water presents some degree of risk and we’re committed to working with states and scientists to ensure public health is protected and meaningful opportunities for reducing risk are fully considered.”

In January 2002, the EPA issued a draft risk assessment finding that 1 part per billion should be considered safe; in March 2006, the Massachusetts Department of Environmental Protection set a maximum contaminant level of 2 ppb; last year, California adopted a standard of 6 ppb.

A National Academy of Sciences panel prepared a risk analysis in 2005 that, according to the EPA’s traditional models, would produce a protective standard of 1 to 6 ppb. The academy’s study came under attack because two of the committee’s members had financial ties to defense contractors that face legal liability because of perchlorate disposal.

The EPA’s proposed ruling assumes that perchlorate contamination of 15 ppb is safe. But its regulatory document states that “between 16,000 and 28,000 pregnant women” and 900,000 to 2 million Americans could be exposed to higher levels.

The EPA document also finds that bottle-fed infants would be exposed to more than five times the level the National Academy of Sciences deemed safe — 700 nanograms per kilogram of body weight per day — if parents mix formula with drinking water containing perchlorate levels of 15 ppb.

OMB officials said during the drafting process that there was “no need” for detailed data to flesh out a table suggesting that infants would be exposed to perchlorate levels above the academy’s recommendation.

To determine safe levels of exposure, the OBM opted not to use the academy’s “reference dose,” a formula that includes a tenfold safety factor to protect children and vulnerable populations, and instead used a computer model developed by the Chemical Industry Institute of Toxicology. EPA officials initially inserted language in the document calling this a “novel approach,” but the OMB deleted that language.

Federal officials have yet to determine the extent of perchlorate contamination nationwide, but it is known to be widespread. The GAO, which produced a 2005 report calling for a better federal tracking system for perchlorate, found that limited EPA data show the chemical compound has polluted the soil, groundwater and drinking water in 35 states and the District and has contaminated 153 public water systems in 26 states.

Stay tuned, and don’t drink the water, or swallow the Kool-Aid.

©2012 An Inconvenient Woman. All Rights Reserved.