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Archives for : Food and Drug Administration

#India must address worrying stock out of tuberculosis drugs #healthcare

 

 

Indian government drug tender process leads to deadly delay in drug supply

 

New Delhi, 17 June 2013 – The Indian government must urgently address the persistent issues and almost routine delays of procuring drugs to treat tuberculosis, international medical humanitarian organisation Médecins Sans Frontières (MSF) said today. The issues are behind a worrying stock out of TB drugs which the country is currently experiencing.

 

“As a country with such a high burden of tuberculosis, MSF is deeply disturbed that India is experiencing stock outs of critically needed drugs to treat children and those with drug-resistant TB”, said Leena Menghaney, India Manager of MSF’s Access Campaign. “In this instance, it’s a stock out that can cost people’s lives and the government must act urgently to fix the problems.”

 

India is currently experiencing stock outs across the country of both paediatric TB drugs and those used to treat drug-resistant TB (DR-TB). Under India’s public TB treatment program, the government is responsible for buying drugs and distributing them to the states which then provide treatment.

 

The stock out is related to the never-ending issues with drug procurement that India faces in many of its public health programmes – the routine but deadly delay in tendering for these drugs – and the resulting drug stock outs are one of the reasons why India has one of the world’s highest burdens of DR-TB.

 

“As a TB treatment provider, MSF is witnessing the impact this is having on our own patients”, said Dr. Homa Mansoor, the TB Medical Referent for MSF India. “In our Mon, Nagaland project, I’ve seen a 12 year-old girl on treatment arrive with her father after a long journey to get her medicine. The medicines were out of stock, but luckily we had six days’ worth of drugs available from a patient who had died. Otherwise, we’re having to resort to breaking adult pills to give to children, which is really dangerous as it could over- or under-dose them.”

 

Other patients have been forced to purchase medicines from private pharmacies, but have received lower-dosage drugs, which – if it causes a patient to under-dose on that drug – could lead to resistance.

 

“A continuous, sustainable supply of quality-assured medicines is vital for TB patients to have even half a chance of being cured”, Dr Mansoor said. “As a doctor, I know the disease, I know how to manage it, but I feel powerless because we don’t have the medicines to treat.”

 

“It’s just not good enough that India talks of scaling up DR-TB treatment, but finds the medicine cabinet empty at a time when the most vulnerable patients – those diagnosed with DR-TB – are most desperate to get the medicines that can treat them”, Dr Mansoor added.  “The Indian Government must act now to address this dire situation.”

 

The stock outs in India are occurring as the World Health Organization late last week issued interim guidelines on bedaquiline, the first new drug to treat TB in 50 years, approved by the US Food and Drug Administration at the end of 2012. MSF has welcomed the release of the guidelines, but has said use of the new drug needs to be regulated and controlled, and studies must be undertaken to find combinations with the new drugs in shorter, more effective and less toxic treatment regimens.

 

 SOURCE- http://www.msfaccess.org/

 

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Protest- Millions march against Monsanto and GM crops

Organisers celebrate huge global turnout and say they will continue until Monsanto and other GM manufacturers listen

Anti-GM protester

Protesters make their point to Monsanto in Los Angeles, California, May 25, 2013. Photograph: Robyn Beck/AFP/Getty Images

Organisers say that two million people marched in protest against seed giant Monsanto in hundreds of rallies across the US and in more than 50 other countries on Saturday.

“March Against Monsanto” protesters say they wanted to call attention to the dangers posed by genetically modified food and the food giants that produce it. Founder and organiser Tami Canal said protests were held in 436 cities across 52 countries.

Genetically modified plants are grown from seeds that are engineered to resist insecticides and herbicides, add nutritional benefits, or otherwise improve crop yields and increase the global food supply. Most corn, soybean and cotton crops grown in the United States today have been genetically modified. But some say genetically modified organisms can lead to serious health conditions and harm the environment.

The use of GMOs has been a growing issue of contention in recent years, with health advocates pushing for mandatory labelling of genetically modified products even though the federal government and many scientists say the technology is safe.

The “March Against Monsanto” movement began just a few months ago, when Canal created a Facebook page on 28 February calling for a rally against the company’s practices. “If I had gotten 3,000 people to join me, I would have considered that a success,” she said Saturday. Instead, she said, two million responded to her message.

Together with Seattle blogger and activist Emilie Rensink and Nick Bernabe of Anti-Media.org, Canal worked with A Revolt.org digital anarchy to promote international awareness of the event. She called the turnout “incredible” and credited social media for being a vehicle for furthering opportunities for activism.

Despite the size of the gatherings, Canal said she was grateful that the marches were uniformly peaceful and that no arrests had been reported.

“It was empowering and inspiring to see so many people, from different walks of life, put aside their differences and come together today,” she said. The group plans to harness the success of the event to continue its anti-GMO cause.

“We will continue until Monsanto complies with consumer demand. They are poisoning our children, poisoning our planet,” she said. “If we don’t act, who’s going to?”

Monsanto, based in St Louis, said on Saturday that it respects people’s rights to express their opinions, but maintained that its seeds improve agriculture by helping farmers produce more from their land while conserving resources such as water and energy.

The US Food and Drug Administration does not require genetically modified foods to carry a label, but organic food companies and some consumer groups have intensified their push for labels, arguing that the modified seeds are floating from field to field and contaminating traditional crops. The groups have been bolstered by a growing network of consumers who are wary of processed and modified foods.

The Senate this week overwhelmingly rejected a bill that would allow states to require the labelling of genetically modified foods.

The Biotechnology Industry Organisation, a lobbying group that represents Monsanto, DuPont & Co and other makers of genetically modified seeds, has said that it supports voluntary labelling for people who seek out such products. But it says that mandatory labelling would only mislead or confuse consumers into thinking products weren’t safe, even though the FDA has said there is no difference between GMO and organic, non-GMO foods.

However, state legislatures in Vermont and Connecticut moved ahead this month with votes to make food companies declare genetically modified ingredients on their packages. And supermarket retailer Whole Foods Markets Inc has said that all products in its North American stores containing genetically modified ingredients will be labeled as such by 2018.

Whole Foods says there is growing demand for products that don’t use GMOs, with sales of products with a “Non-GMO” verification label spiking between 15% and 30%.

 

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#India – Ranbaxy Lab Lted agrees selling adulterated drugs, fined $500 million penalty

By ERIC TUCKER
Associated PressWASHINGTON (AP) – A subsidiary of India’s largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.

Federal prosecutors say the guilty plea by Ranbaxy USA Inc. represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

The deal, announced Monday, concludes a years-long federal investigation into Ranbaxy’s manufacturing deficiencies. The Food and Drug Administration in 2008 barred from Ranbaxy from importing more than 30 different drugs made at factories in India and, two years ago, struck a deal that required the company to ensure that data on its products is accurate, undergo extra oversight and review from a third-party and improve its drug making procedures.

The subsidiary of Ranbaxy Laboratories Limited pleaded guilty to federal criminal charges and the company separately agreed to resolve civil claims with all 50 states and the District of Columbia. The company had earlier set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.

It admitted as part of the deal that it sold adulterated batches of drugs – including an antibiotic and generic versions of medications used to treat severe acne, epilepsy and nerve pain – that were developed at two manufacturing sites in India. It’s not known whether the problems with the drugs led to any health issues. The problems were largely revealed by a whistleblower in a federal lawsuit filed in Maryland in 2007. The government’s allegations against the company make no claims that the drugs, whose strength, purity or quality differed from the specifications, harmed anyone.

The company admitted to a wide range of deficiencies, including improperly storing drug samples that awaiting testing, continuing to sell a medication in the U.S. even after it had failed purity tests and delaying a voluntary recall of medication that it knew would not maintain its expected its expected shelf life.

Ranbaxy also admitted making false statements to the FDA in 2006 and 2007 annual reports about dates of tests that are designed to detect drug impurities and determine appropriate storage conditions. In some cases, the tests were done weeks or months after the company said they’d been performed. Or the tests were done on the same day – or within days of each other – instead of months apart, the prescribed interval.

The company said in a written statement that it had fully cooperated with the investigation, which it said involved actions from several years ago, and expects “future growth in the U.S. and around the world with a robust pipeline of important products.”

“While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance,” Ranbaxy CEO and managing director Arun Sawhney said in a statement.

The company had faced scrutiny in recent years. Apart from the federal investigation, Ranbaxy Pharmaceuticals Inc. – also a subsidiary of Ranbaxy Laboratories Limited – halted in November of generic cholesterol drug Lipitor while it investigated how tiny glass particles got into dozens of recalled batches. The FDA determined at the time that the risk to patients was very low.

The case comes as federal regulators and prosecutors focus attention on the quality of ingredients of generics and other drugs manufactured overseas, said Allan Coukell, an expert on drug safety at The Pew Charitable Trusts. He said the 2008 deaths linked to tainted batches of the blood-thinner heparin that were imported from China served as a “wake up call” about just how much of the nation’s drug supply comes from overseas.

“Over the last few years, the FDA and others have been increasingly focused on the risks associated with global drug manufacturing. The agency now has new authority and new resources which should result in an increased scrutiny on the highest-risk facilities,” he said.

The company agreed as part of Monday’s deal to a fine and forfeiture of $150 million as well as an additional $350 million penalty to settle civil claims that it submitted false statements to Medicaid, Medicare and other government health care programs. Nearly $49 million of that penalty will go to a former Ranbaxy executive, Dinesh Thakur, who acted as a whistleblower by filing a federal lawsuit accusing the company of knowingly falsifying drug data, prosecutors said.

Thakur said in a statement that the company had been notified of the problems, and “when they failed to correct the problems, it left me with no choice but to alert healthcare authorities.”

“He was the source, the original source, of the information to the government that ultimately led to the government’s earlier actions,” said Andrew Beato, one of Thakur’s lawyers.

 

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Morning after’ pills legit for 15-year-olds in US #womenrights

TNN | May 2, 2013,

WASHINGTON: The US government has lowered to 15 the age at which girls can buy the morning-after contraceptive pill without a prescription. The US Food and Drug Administration (FDA) on Tuesday announced to approve a contraceptive known as Plan B or popular as “morning after pill” for all women 15 and older.The announcement is expected to stir the controversy among conservatives who consider it another form of abortion. In a statement, the FDA said the approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases.

These data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider. “Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the US,” said FDA commissioner Margaret A Hamburg. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” Hamburg said.

FDA said because the product will not protect a woman from HIV or AIDS or other sexually-transmitted diseases, it is important that young women who are sexually active remember to see a health care provider for routine checkups.

 

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Drug Patent Rights India Wins First Round Novartis Full Text of Judgement

 

The instances of Multinationals stealing indigenous medicines is well-known.

So are the capricious overpricing of life saving Drugs, like Cancer Drugs.

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on Monday. It also ruled that under the license Natco must pay 7 per cent in royalties on net sales to Bayer.

Bayer sells a one month supply of the drug for about $5,600. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much.

Western pharmaceutical companies have been pushing for stronger patent protections inIndia to regulate the country’s $26 billion US generics industry, which they say frequently flouts intellectual property rights. However, health activists and aid groups counter that Indian generics are a lifesaver for patients in poor countries who cannot afford Western prices to treat diseases such as cancer, malaria and HIV.’

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

Big Court Ruling Favors Generic Drugs: The Times’s Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world.

India drew first blood in a Patent case in The Supreme Court .

DOWNLOAD FULL JUDGEMENT

‘People in developing countries worldwide will continue to have access to low-cost copycat versions of drugs for diseases like H.I.V. and cancer, at least for a while…

Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.

Cost of Glivec used for targeted therapy in CML patients: 1 lakh per month (approx)

Cost of its generic versions : 8,000 -10 ,000 per month

No. of cancer centres in India: 450 approx (half are in the private sector)


The debate over global drug pricing is one of the most contentious issues between developed countries and the developing world. While poorer nations maintain they have a moral obligation to make cheaper, generic drugs available to their populations — by limiting patents in some cases — the brand name pharmaceutical companies contend the profits they reap are essential to their ability to develop and manufacture innovative medicines.

Specifically, the decision allows Indian makers of generic drugs to continue making copycat versions of the drug Gleevec, which is made by Novartis. It is spelled Glivec in Europe and elsewhere. The drug provides such effective treatment for some forms of leukemia that the Food and Drug Administration approved the medicine in the United States in 2001 in record time. The ruling will also help India maintain its role as the world’s most important provider of inexpensive medicines, which is critical in the global fight against deadly diseases. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

The ruling comes at a challenging time for the pharmaceutical industry, which is increasingly looking to emerging markets to compensate for lackluster drug sales in the United States and Europe. At the same time, it is facing other challenges to its patent protections in countries like Argentina, the Philippines, Thailand and Brazil.

“I think other countries will now be looking at India and saying, ‘Well, hold on a minute — India stuck to its guns,’ ” said Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge, a group based in New York that works on patent cases to foster access to drugs.

In trade agreements — including one being negotiated between the United States and countries in the Pacific Rim — the drug industry has lobbied for stricter patent restrictions that would more closely resemble protections in the United States.

 

  • #India- SC rejects Novartis’s patent plea for cancer drug Glivec #goodnews (kractivist.wordpress.com)

 

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Maharshtra Govt threatens to invoke Mesma on chemists #healthcare

HC Asks State To Take Chemists’ Problems Into Account

Rosy Sequeira TNN

The state government on Thursday told the Bombay HighCourtthatitis exploring the possibility of applying the Maharashtra Essential Services Maintenance Act against chemists who are on strike. However, chemists claimed they were merely closing their shops early and were not on strike.
A division bench of Chief JusticeMohit Shah andJustice Anoop Mohta was hearing an application by advocate Datta Mane to revive his earlier PIL seeking prosecution of members of the Maharashtra State Chemists & Druggists Association, to restrain them from going on strike and find a permanent solution to the issue. Advocate SnehalRatnakar submitted on Mane’s behalf that greathardship willbecausedto peopleduetothestrike.
However, the association’s advocate told the bench it was not a strike but an individual decision taken by some chemists to keep their shops open from 10am to 6pm. He said it was prompted by visits at odd hours, like 3am, by Food and Drugs Administration officials asking about the presence of pharmacists. “If a pharmacist is not presentor hassteppedout
to answer nature’s call, they serve a stop-sell notice,’’ hesaid, adding there was a shortage of pharmacists in the state. He said there were about 70,000 chemist shops in the state but only 55,000 pharmacists, adding many pharmacists take up other jobs. He said while chemists are ready to keep their shops open beyond 6pm, the government must not insist on the presenceof pharmacists.
However, government pleader S S Shinde said the action being taken was statutory and chemists were acting contrary to the undertaking given when applying for licences, which stated they will keep their shops open for at least 12 hours. “It is not a flimsy
ground, we have consistently found that qualified pharmacists are not available,’’ he added. The association’s advocate saidsincetheHC’sOctober 2012 order,the governmentdid nothing and not a single meeting washeldon theissue.
Shinde argued chemists have gone on strike in retaliation againstthe action initiated by the FDA. “We are exploring the possibility of taking action under the Essential Services Act. The commissioner has power to prohibit a strike,’’ said Shinde.
The judges asked the government to show the provision in lawunder which it can insist chemists keep their shops open. The judges also observed that the government must understand the difficultiesof chemists. “Try to understand their difficulty also. Have at least one meeting with them,” said Justice Shah.Thejudgesdirected the government to file a reply and produce a copy of the chemists’ undertaking atthehearing on March 8.
What is Mesma
The Maharashtra Essential Services Maintenance Act came into effect in Maharashtra in July 2012. It is applicable to providers of essential services to the public at large. An offence under the Act is cognisable and punishable with imprisonment up to 1 year. The Act empowers police to arrest offenders without a warrant

 

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#India -Pharma firms ply doctors with gifts #medicalethics

Published: Thursday, Dec 27, 2012, 5:30 IST
By Sandeep Pai | Place: Mumbai | Agency: DNA

Even as the prime minister Manmohan Singh-led National Development Council meets on Thursday to discuss a law to curb unethical practices adopted by pharmaceutical companies to persuade doctors to promote their products, a four-month investigation by DNA has shown that the ‘pay-for-prescription’ practice flourishes.

While doctors admit that there is a grave danger of drugs being overused when pharmaceutical companies woo doctors and stockists with various sops for promoting their drugs, even the parliamentary standing committee on health and family welfare in a report dated May 8, 2012 says there is no let-up in this “evil practice”. It says, “… pharma companies continue to sponsor foreign trips of many doctors and shower them with high value gifts like air conditioners, cars, music systems, gold chains etc… to obliging prescribers who then prescribe costlier drugs as quid pro quo. Ultimately all these expenses get added up to the cost of drugs.” What’s more, the pharma firm-doctor nexus is not limited to innocuous over-the-counter drugs, a DNA investigation has found.

Take the example of US Vitamin (USV) Ltd, a major player in the oral antibiotics market. In August 2011, its product manager wrote to company representatives appreciating their efforts in making its product, Drego-D, the Number 1 prescribed brand in the preceding two months. The letter went on to say they should also push another drug, Drego, similarly, given the huge opportunity it presents. All doctors except paediatricians have the potential to prescribe Drego, the letter urged. Drego and Drego-D are both Schedule H drugs, to be sold only on the prescription of a registered medical practitioner.

The letter goes on to detail the promotional activities for the Drego group of drugs, including “on demand campaign” every month specifically for general practitioners, ENT specialists, orthopaedics, gynaecologists and more. l Turn to p9

The “engagement” and “development activity” for these doctors included investment of Rs65,000/ year or Rs80,000 per year on one or two selected doctors for a single drug, the letter revealed.

“…with such a line of promotion we are sure that you all will very easily achieve a minimum per member per month (PMPM) of 250 strips of Drego & 350 strips of Drego-D,” the letter said, going on to insist that representatives should, during their field work, ensure that doctors give Drego prescriptions “on priority”. The letter posted a target a business worth Rs14 crore for a single drug in a single year.

The company’s brochure also says doctors stood to win a smartphone or LCD television once they enter the “MPower Club” for a certain number of prescriptions of Zylera, a drug for nasal problems or asthma-like symptoms, also a Schedule H drug.
Franco India, expected to have a turnover of Rs2.1 billion this year, offers a variety of gifts to doctors, including a hamper of basmati rice, handmade orange soap, an all-in-one mobile phone charger and other stationery items.

Svizera Healthcare, a division of Maneesh Pharmaceuticals Limited, issued a brochure called Club Inspira 2010-2011, which invites doctors to become members by prescribing products worth Rs50,000 between May and August 2010. The prescriptions would have to be for Si-Fixim, Si-Fixim XL, Si-Fixim CV, FlanZen, FlanZen D/DP and others.

These are all highly sensitive drugs. Si-Fixim is generally used for the treatment of infections caused by susceptible bacteria. Doctors prescribe the medicine to patients suffering from upper respiratory tract infections, such as pharyngitis, sinusitis, tonsillitis and lower respiratory tract infections like acute bronchitis and acute exacerbation of chronic bronchitis etc. FlanZen is prescribed for reducing inflammation and edema occurring due to rheumatic disorders, surgeries, breast engorgements, pregnancy-related thrombophlebitis as well as fibrocystic breast diseases. It causes hypersensitivity reactions including rashes, abdominal discomfort and nausea if not taken properly.
Those entering the ‘club’ would be eligible for a gift, with their options ranging from a microwave oven, digital camera, a gold coin, etc.

While doctors get incentives for prescriptive drugs, incentives are offered to stockists for non-prescriptive drugs too. Though some may debate that there is nothing wrong in offering incentives to the stockists, but others believe it does make the stockist unethically push for product in order to win the gifts. While doctors get incentives for prescriptive drugs, incentives are offered to stockists for non-prescriptive drugs too.

A Gelusil festival extravaganza was announced by Pfizer to strengthen the product’s position as the Number 1 antacid in its category. Distributors were offered slab-wise gifts for achieving targets and also a chance to participate in a lucky draw. A similar offer had been launched last year for Becosules, the vitamin supplement. On offer was a chance to win diamond pendants, gold chains, travel bags, LCD televisions, home theatres, and wrist-watches.

While most pharma companies DNA approached refused to respond to queries on ethical practices while promoting drugs, Pfizer spokesperson Shyam Kumar said the company takes compliance with norms very seriously. “In fact, over the past several years, Pfizer has taken very significant steps to strengthen our internal controls and pioneer new procedures in the area of compliance. Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to strengthen public trust in our company.”

Dr Kailash Sharma, member, board of governors, Medical Council of India, and director, academics, Tata Memorial hospital, said, “MCI has already given strict guidelines but the practice of accepting gifts is so prevalent, it becomes difficult to monitor. Doctors must restrain themselves from accepting gifts or foreign trips from pharma companies. There is a need to bring in penal provisions for pharma companies, which offer gifts to doctors. There is also a need to audit the accounts of pharma companies to know how much they are spending on publicity.”

 

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Doctors engineering fetuses to prevent intersex, tomboys and lesbians #WTFnews

Dangerous Experiment in Fetal Engineering

 

By Marla Paul

CHICAGO — A new paper just published in the Journal of Bioethical Inquiry uses extensive Freedom of Information Act findings to detail an extremely troubling off-label medical intervention employed in the U.S. on pregnant women to intentionally engineer the development of their fetuses for sex normalization purposes.

The paper is authored by Alice Dreger, professor of clinical medical humanities and bioethics at Northwestern University Feinberg School of Medicine and is co-authored by Ellen Feder, associate professor of philosophy and religion at American University, and Anne Tamar-Mattis, executive director of Advocates for Informed Choice.

The paper is authored by Alice Dreger, professor of clinical medical humanities and bioethics at Northwestern University Feinberg School of Medicine and is co-authored by Ellen Feder, associate professor of philosophy and religion at American University, and Anne Tamar-Mattis, executive director of Advocates for Informed Choice.

The pregnant women targeted are at risk for having a child born with the condition congenital adrenal hyperplasia (CAH), an endocrinological condition that can result in female fetuses being born with intersex or more male-typical genitals and brains. Women genetically identified as being at risk are given dexamethasone, a synthetic steroid, off-label starting as early as week five of the first trimester to try to “normalize” the development of those fetuses, which are female and CAH-affected. Because the drug must be administered before doctors can know if the fetus is female or CAH-affected, only one in eight of those exposed are the target type of fetus.

The off-label intervention does not prevent CAH; it aims only at sex normalization. Like Diethylstilbestrol (DES) — which is now known to have caused major fertility problems and fatal cancers among those exposed in utero — dexamethasone is a synthetic steroid. Dexamethasone is known — and in this case intended — to cross the placental barrier and change fetal development. Experts estimate the glucocorticoid dose reaching the fetus is 60 to 100 times what the body would normally experience.

The new report provides clear evidence that:

  • For more than 10 years, medical societies repeatedly but ultimately impotently expressed high alarm at use of this off-label intervention outside prospective clinical trials, because it is so high risk and because nearly 90 percent of those exposed cannot benefit.
  • Mothers offered the intervention have been told it “has been found safe for mother and child” but in fact there has never been any such scientific evidence.
  • The U.S. Food and Drug Administration has indicated it cannot stop advertising of this off-label use as “safe for mother and child” because the advertising is done by a clinician not affiliated with the drug maker.
  • A just-out report from Sweden in the Journal of Clinical Endocrinology and Metabolism documents a nearly 20 percent “serious adverse event” rate among the children exposed in utero.
  • Clinician proponents of the intervention have been interested in whether the intervention can reduce rates of tomboyism, lesbianism and bisexuality, characteristics they have termed “behavioral masculinization.”
  • The National Institutes of Health has funded research to see if these attempts to prevent “behavioral masculinization” with prenatal dexamethasone are “successful.”
  • The United States’ systems designed to prevent another tragedy like DES and thalidomide — involving de facto experimentation on pregnant women and their fetuses — appear to be broken and ineffectual.

The paper is available for free download at: http://www.springerlink.com/content/m1523l7615744552/?MUD=MP

Marla Paul is the health sciences editor. Contact her at [email protected]

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Monsanto’s Deep Roots In Washington

seedling.jpg

By Russ Choma

 
It’s planting season, which brings to mind one of the most ubiquitous names in agribusiness: Monsanto

Love it or hate it — and there are plenty of people on either side — the company controls much of the agricultural market, and also sells products for the suburban yard such as the weed-killer Roundup. Roundup is the core of Monsanto’s agricultural breakthrough: The company produces genetically modified seeds that are resistant to the herbicide, making it easy for farmers to spray whole fields of soy or corn and kill only the weeds. Food production made easy.
On the flip side, environmentalists and organic food fans maintain there are too many unknowns and potential dangers involved with genetic modification. Monsanto, which last year had revenues of $11.8 billion, has become their bogeyman.

But such efforts as grassroots petitions and proposed legislation to require at least the labeling of genetically modified food have thus far withered on the vine next to Monsanto’s deeply rooted Washington presence, which has proved resistant to most lines of attack.

According to OpenSecrets.org data, in the first three months of this year, Monsanto spent$1.4 million lobbying Washington — and spent about $6.3 million total last year, more than any other agribusiness firm except the tobacco company Altria.

Monsanto’s interests in Washington are diverse. It lobbied bills ranging from the American Research and Competitiveness Act of 2011, which would extend tax credits for companies doing research, to several bills that would change the way the Department of Homeland Security handles security at chemical facilities — chemicals being a big part of Monsanto’s product portfolio.

And just as important as Monsanto’s legislative agenda for 2011 and 2012 is its regulatory one: the company’s lobbying reports list the departments and agencies it visited to talk to federal bureaucrats and appointees as they wrote rules to implement and enforce Congress’ handiwork. That explains why Monsanto reports having lobbied the U.S. Department of Agriculture, the Food and Drug Administration, theEnvironmental Protection Agency and many other executive branch offices.

The FDA currently is the target of a petition signed by more than 1 million people, according to a sponsor known as Just Label It, asking the agency to require that genetically engineered food be labeled as such. The petition, sponsored by a coalition of environmental and food groups, is an attempt by activists to make an end-run around Monsanto’s Washington operation — a necessity because their lobbying dollars pale in comparison to the cash spent by Monsanto and others in the industry. For instance, one of the coalition members, the Environmental Working Group, has spent just $82,000 on lobbying this year — or about 5 percent of Monsanto’s total.

“The power of Monsanto, whether in the halls of Washington, or in farm country, should not be ignored,” said Environmental Working Group spokesman Alex Formuzis. “Monsanto comes armed with some of the deepest pockets and a bench of influential lobbyists, which makes the coalition’s efforts over GMO labeling on behalf of consumers a very tough fight indeed.”

Another upcoming matter of great interest to Monsanto: the new farm bill, an omnibus piece of legislation that sets the nation’s agricultural policy and deals with nearly every aspect of the country’s farming and food industries. The current bill expires in 2013; when it went through Congress, Monsanto filed more lobbying reports on it than any other organization. The process of piecing together a new proposal is already well under way.

The company’s access to members of Congress who are likely to be key in shaping the final legislation may be eased by the contributions of its very active PAC, the Monsanto Citizenship Fund. Already this cycle it has spent $383,000. The biggest recipient of that money so far is Rep. Frank D. Lucas (R-Okla.) who has received $20,000 from Monsanto’s PAC — $10,000 for his campaign committee and $10,000 for his leadership PAC. Lucas happens to be the chairman of the House Agriculture Committee — no farm-related legislation is passed without his say-so.

Monsanto has hedged its investment with the agriculture committee, though — it also gave $13,500 to Rep. Collin Peterson (D-Minn.), the top-ranking Democrat on the committee. So far this election cycle, Monsanto’s PAC has given $77,500 to 17 members of the House agriculture committee, or their leadership PACs.

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