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A Racist Turn in India

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African students demonstrated against discrimination at a protest in New Delhi last June. Deepak Malik/Demotix via Corbis

Contributing Op-Ed Writer

By NILANJANA S. ROY

NEW DELHI — The Africans — Nigerians, Ghanaians, Ugandans — began leaving my neighborhood in New Delhi around December. Each week, more and more families exited. Some went to parts of Delhi considered more accepting of Africans; others to areas where the residents were thought to be less interfering in general. I have heard that some of the Ghanaian families had gone back to Africa, but I don’t know that for sure.

For years, they had been a part of the swirl of cultures, languages and races that makes up this part of the capital. The Nigerian women in their bright dresses out for evening strolls and the Cameroonian family with the curious-eyed baby at the ice-cream van had made a life for themselves alongside the Afghans, Tamils and Iranians.

On Oct. 31, about a month before the departures started, a Nigerian national, rumored to have been in the drug trade, was found dead in Goa. Nigerians in the coastal state protested his murder as an act of racism, while posters read: “We want peace in Goa. Say no to Nigerians. Say no to drugs.” One state minister threatened to throw out Nigerians living illegally. Another equated them with a cancer. He later apologized, adding that he hadn’t imagined there would be a “problem” with his statement.

The controversy has reverberated across the country, including in Delhi, 1,200 miles away, where the tolerance of African neighbors has turned into suspicion and even hostility.

One night, a police constable rang my doorbell. “Have you seen any man from the Congo entering and leaving the building?” he asked. “African man,” he clarified. He said he had received a report that a local resident was friendly with Africans, and he wanted to know, was this true? The question surprised me; neighborhood battles here are waged over water and parking spaces, not over ethnicity. Now neighbors had become nervous of neighbors.

Once the African communities had been singled out, complaints against them bubbled up like filthy water, in Jangpura, in Khirki Extension, in the alleyways off Paharganj, anywhere in Delhi they lived.

The fragile hospitality gave way to a familiar litany of intolerance: They were too loud, exuberant and dirty; the women were loose, the men looked you directly in the eye, they were drug takers and traffickers, and worse.

Residents of Khirki Extension, whose rambling lanes had seen an influx of artists, journalists and migrants, conducted their own investigation of their African neighbors, which they called the “black beauty” sting.

Coinciding with the city’s darkening mood, the newly elected Aam Aadmi Party in Delhi started a wave of cleanups as part of its mission to control “lawlessness.” The city’s law minister, Somnath Bharti, led a raid into Khirki Extension, claiming to be acting on residents’ complaints that Nigerians and Ugandans were involved in prostitution and drug trafficking. Media reports suggest that on the night of Jan. 15, he entered Africans’ homes with a group of vigilantes, without a warrant. In the fracas, a Ugandan woman was allegedly forced to give a urine sample, on the street, in the middle of the crowd. After she filed a complaint, Delhi’s court ordered the Police Department to pursue her case against Mr. Bharti.

These recent events have awakened dormant prejudices against Africans in India, aggravated by our tendency to prize fair skin over dark. “Habshi,” derived from the word “Abyssinian,” has become a common epithet for people of African descent.

So, on one hand, the racist turn in Delhi and Goa is unsurprising. On the other hand, we have a long, and neglected, history of cross-migration with Africa. While Indians have been settling on that continent since at least the 15th century, African roots in India run even deeper. Africans were brought over in numbers around the 13th century as slaves, but also as generals, guards, merchants, bodyguards and craftsmen. Many never went back. Now tens of thousands are here to study, and others work as chefs and in the garment and textile businesses, among other industries.

Despite our close ties and the shared history of colonialism, Africa doesn’t figure on the Indian map of curiosity and desire. Our admiration of China’s economic prowess is commonplace and unabashed; we are obsessed with the West, in terms of education, ideals of beauty and economic might. But Africa is invisible. Racist views can be spouted without consequence. Africa simply doesn’t matter.

There will be few repercussions for the Aam Aadmi Party if it continues with blanket policies against Africans. The party won on the promise of change, yet here it is, proving that it shares the same blindness as other, older parties.

These days, the Afghans and Indians stroll in my neighborhood park, enjoying the winter breeze. The Ghanaian and Cameroonian families moved away when their landlords doubled the rent only for them; the young Nigerian women left after one police visit too many.

Delhi’s residents say that the city belongs to everybody, because it belongs to nobody. As Bangalore and Mumbai became insular possessions, with political parties often driving out anyone who was from elsewhere, the capital claimed that it had room for all kinds of migrants, expats and outsiders. If the Aam Aadmi Party continues the divisiveness that older parties have excelled at, we’ll soon find reasons to go after all the people who live differently from “us,” who don’t belong here, who should go back to the places they came from.

Nilanjana S. Roy is an essayist and critic, and author of the novel “The Wildings.”

Read more here —  http://www.nytimes.com/2014/01/25/opinion/roy-the-wrong-kind-of-foreigner.html?hp&rref=opinion

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6 Drugs Whose Dangerous Risks Were Buried So Big Pharma Could Make Money

Why some drugs cost more in Singapore
New meds are rushed to the market so industry can start making money even before safety has been determined.
January 15, 2014  |
 Editor’s note: The following article is a follow up to a previous AlterNet piece about drugs whose dangerous side-effects emerged only after the pharmaceutical industry’s patents ran out. Read part 1 here.

When a prescription drug causes risky side effects, the word often doesn’t get out for years, allowing Big Pharma to make money anyway.

The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck’s risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because “the drug potentially provided a significant therapeutic advantage over existing approved drugs,” the FDA said.

Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.

Here are some drugs whose risks did not did not keep them from getting their “patent’s worth.”

1. Singulair

You’d think Merck would have learned from Vioxxand Fosamax that aggressive marketing can only hide emerging risks for so long. It didn’t. To sell its asthma and allergy drug Singulair to children, the drug giant partnered with Olympic gold-medalist swimmer Peter Vanderkaay and Scholastic and the American Academy of Pediatrics even as the FDA warned about “neuropsychiatric events” including agitation, aggression, nightmares, depression, insomnia and suicidal thinking.

While Merck marketed Singulair, which comes in a cherry-flavored chewable formulation, to parents with slogans like “Singulair is made with kids in mind,” Fox TV and over 200 parents on the website askapatient reported that children on Singulair exhibited altered moods, depression and ADHD, hyperkinesis and suicidal symptoms. Fifteen-year-old Cody Miller of Queensbury, NY reportedly took his own life days after taking the drug in 2008. Still, Singulair made $5 billion for the company in 2010. After its patent expired in 2012, Australia’s Therapeutic Goods Administration, the FDA’s counterpart, reported 58 cases of adverse psychiatric events in children and teenagers, primarily suicidal thinking. Who knew?

2. Zyprexa

How do you sell a drug that causes 30 percent of users to gain 22 pounds and some to gain as much as 100 pounds? By burying the risks. The antipsychotic Zyprexa was supposed to be Eli Lilly’s followup to its blockbuster antidepressant Prozac even though  Lilly knew as early as 1995, according to the New York Times, that Zyprexa was linked to unmanageable weight gain or diabetes. Zyprexa’s side effects of “weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” wrote Lilly’s Alan Breier, who later became chief medical officer, in documents obtained by the Times.

Even as Lilly settled charges that it withheld the drug’s link to high blood sugar levels and diabetes and illegally marketed the drug for dementia, Zyprexa made $5 billion in 2010 and out-earned Prozac. Who says crime doesn’t pay? Zyprexa was especially marketed to the poor and became one of the nation’s top Medicaid drugs extracting at least $1.3 billion of our tax dollars in 2005 alone. In 2008, Lilly settled an Alaskan suit to cover the cost of Medicaid patients who developed diabetes on Zyprexa. Unbelievably, Lilly offered a “free service” to “help” states buy mental illness drugs like Zyprexa as a fox guards the henhouse and 20 states took the bait. Zyprexa’s patent ran out in 2012.

3. Seroquel

Like Zyprexa, the antipsychotic Seroquel, made by the UK firm AstraZeneca, became a best-selling medication in the US, earning over $5 billion in 2010, despite frequently reported risks. It was so heavily marketed to poor children that in 2007, Florida’s Department of Juvenile Justice’s bought twice as much Seroquel as Advil. Seroquel’s high use in the military for the unapproved uses of sleep and PTSD was also disturbing: reports of veterans’ sudden deaths on the drug, thought to be cardiac-related, surfaced even as use of Seroquel soared 700 percent in the Department of Defense. In 2009, it was the number-two drug at the VA, accounting for $125.4 million in tax dollars.

Months after Seroquel’s 1997 approval, an article in the South Dakota Journal of Medicine raised questions about the drug’s unsafe interaction with 11 other drugs. Within three years, researchers at the Cleveland Clinic were questioning Seroquel’s effect on the heart’s electrical activity. But even as the families of deceased veterans testified at FDA hearings in 2009 and demanded answers from officials and lawmakers, the FDA maintained Seroquel’s safety. Then in 2011, with little fanfare, the FDA issued new warnings that corroborated the swirling suspicions: both Seroquel and its extended release version “should be avoided” in combination with at least 12 other medicines, said the FDA. The drug should also be avoided in the elderly and people with heart disease because of clear cardiac risks. Oops. Seroquel’s patent ran out the following year.

4. Levaquin

Fluoroquinolone antibiotics are among the biggest-selling drug classes. Many people remember the fluoroquinolone Cipro (given for 9/11-era anthrax attacks) but Pharma hopes we don’t remember the fluoroquinolones Trovan, which was withdrawn for causing liver damage, and Raxar, which was withdrawn for causing cardiac events and sudden death. Johnson & Johnson’s fluoroquinolone Levaquin was the US’ best-selling antibiotic in 2010 with sales over a $1 billion a year but is now the subject of thousands of lawsuits.

In 2012, a year after Levaquin’s patent expired, a cascade of side effects began to emerge with Levaquin and the whole class of fluoroquinolones that casts doubt about their safety. The Journal of the American Medical Association reported that of 4,384 patients diagnosed with retinal detachment, 445 (10 percent) were exposed to a fluoroquinolone in the year before diagnosis. The New England Journal of Medicine reported the same year that Levaquin was linked to an increased risk of cardiovascular death, especially sudden death from heart rhythm disturbances.

While the FDA warned of tendon ruptures on fluoroquinolones, especially Achilles’ tendons in 2008, and added a black box warning on the label, it had a serious new warning two years after Levaquin went off patent. In 2013, the FDA warned about the “the serious side effect of peripheral neuropathy” in fluoroquinolones, a type of nerve damage in which sensory pathways are impaired. Peripheral neuropathy caused by fluoroquinolones like Levaquin can “occur soon after these drugs are taken and may be permanent,” warned the FDA. Fluoroquinolones are also linked to Clostridium difficile, also called C. Diff, a serious and potentially deadly intestinal microbe.

5. Topamax

Before its patent expired in 2009, the seizure drug Topamax made Johnson & Johnson a billion a year and it still made $538 million a year after its patent expiration. Topamax was such a favorite for pain conditions in the military it was given the nickname “Stupamax” for the way it slowed reaction times and impaired motor skills, attention and memory, according to Army Times. Not too great for combat.

A year before Topamax went off patent, the FDA warned that it and other seizure drugs are correlated with suicide and asked their manufacturers to add label warnings. Four patients on the drugs killed themselves versus none on placebo reported the FDA after reviewing clinical trials. Then, in 2011, the FDA announced that Topamax can cause the birth defects cleft lip and cleft palate in babies of mothers who take the drug. “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professional,” the FDA warned, though the risks did not stop the FDA from approving a new diet drug containing Topamax’ generic drug in 2012.

6. Oxycontin

Purdue Pharma’s Oxycontin is the granddaddy of drugs that make money despite lethal side-effects. Along with other prescription opioids, it accounted for an astounding 17,000 deaths last year—four times that in 2003. “The increase [in use] has been fueled in part by doctors and pain advocacy organizations that receive money from drug companies and make misleading claims about the safety and effectiveness of opioids, including that addiction is rare,” reported the Journal Sentinel.The American Geriatrics Society used Pharma-linked experts to rewrite clinical guidelines in 2009, says the Journal Sentinel, which specified opioids for all patients with moderate to severe pain as opposed to Aleve or AdvilKa-ching.

Oxycontin, because it is a long-acting formulation, was supposed to reduce toxicities and addictiveness—at least until its crush, snort and shoot potential made it more popular than cocaine on the street. (All the pill’s 80mg could be taken at once.) In 2010, responding to the addictions, overdoses, deaths and diversions associated with the drug, Purdue rolled out a tamper-resistant Oxycontin and began to push for state and federal laws requiring opioids to be tamper-resistant in 2012. Purdue said public health was its main concern but many are asking why that concern only surfaced as Oxycontin’s patent was expiring. Its patent expired in 2013.

Martha Rosenberg is an investigative health reporter and the author of Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus Books).

 

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How to save $25 billion and more on drug costs

Author(s):
Issue Date:
2013-8-31

Patent settlements bring cheaper generics to market early and cut healthcare spending

imageIllustration: Anirban BoraSummer has been the season of squalor and scandal for the pharmaceutical industry worldwide. For India, it was the disgrace of Ranbaxy’s improperly manufactured drugs and fraudulent practices, charges that it settled by paying a $500 million fine to the US Food and Drug Administration. That was in May. A month later, both the European Union and the US took action against drug companies that had entered into unethical pay-for-delay deals to keep low-cost generic versions of their medicines out of the market on both sides of the Atlantic.

In the second instance, the European Commission fined Lundbeck of Denmark and its generic colluders €146 million or $195 million. The pharma company had in 2002-03 paid companies such as Ranbaxy—yes, it figured in this case, too — and Merck KGaA of Germany to delay market entry of cheaper generic versions of a blockbuster anti-depressant called citalopram. A nasty part of this story is the revelation that the Danish company destroyed large amounts of the generic medicine. All of which put a heavier burden on Europe’s public health system.

At about the same time, the US Supreme Court ruled that innovator drug companies that pay rivals to keep generic versions of top-selling drugs out of the market can be sued by Federal Trade Commission for potential antitrust violations. A majority decision by a five-member bench of the apex court effectively reversed a lower court ruling that had found pay-for-delay agreements were legal as long as these covered just the drug’s patent term. The decision, however, did not declare these deals, also termed reverse payment agreements, illegal per se. Instead, the court instructed the lower courts to apply a “rule of reason” to these cases.

These are landmark decisions because they will result in the availability of a larger number of generic drugs in the marketplace and bring down costs—for both patients and the public health system. But there is controversy. While the public perception is that drug developers, that is the innovator companies, will now find it difficult to face the competition from generics, which can cost as little as 10 per cent of the brand name drugs, there are dissenting views. Some consumer activists believe that patent settlements are not what they are cracked up to be since some, they say, help to maintain market exclusivity for brand name drugs and thus restrict competition. However, innovator and generic firms have insisted that these settlements allow generic drugs to come to market earlier than through high-cost time-consuming legal suits over patent rights.

Now comes a study that hopes to settle the debate by putting a stunning figure to the savings that can be made in public spending on healthcare in the US through patent settlements. The just-released research conducted by the Connecticut-based IMS Institute for Healthcare Informatics shows that generic medicines that come to the market through patent settlements helped the US healthcare system to save $25.5 billion between 2005 and 2012. This is based on an analysis of just 33 molecules. IMS projects an additional saving of $61.7 billion if the current level of pricing continues through to patent expiry for each of these molecules. The other eye-opener is that, on average, these settlements helped to bring generic medicines to market 81 months sooner than patent expiry.

Generic drug makers have been encouraged to challenge patents on lucrative brand-name drugs through the 1984 Drug Price Competition and Patent Term Restoration Act, popularly known as the Hatch-Waxman Act.

Patent settlements are reached when a generic manufacturer challenges the validity of a brand’s patent and the two companies settle the litigation through an agreement based on their respective assessment of the patent’s validity and probability of a successful challenge.

The IMS study was conducted for the Generic Pharmaceutical Association (GPhA) which represents US manufacturers and distributors of finished generic pharmaceuticals and bulk pharma chemicals. “For years, opponents of pharmaceutical patent settlements have stated that settlements create a cost for consumers, the government and others. This new analysis provides the most current, complete and transparent estimate of the impact of patent settlements on health costs, and it shows that the opposite is true,” says Ralph G Neas, president and CEO of GPhA, in a press release. “In particular, the new analysis estimates that patent settlements— including those with consideration—have led to billions in savings. For example, the settlement involving Lipitor alone will save $22 billion over the next four years. This is critical for lawmakers to understand, because any further restrictions on settlements will put these savings at risk.”

While this might not clear up all the uncertainties over patent settlements, what is undeniable is the increasing market domination of generics. One straw in the wind: US drug giant Merck’s second-quarter profit for 2013 fell by half as generic competition cut into revenue from older medicines.


 

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US agency confirms suspension of India clinical trials

The NIH, an arm of the US health department, has cancelled approximately 40 ongoing clinical trials in the country. Photo: Mint

 

NIH says recent clinical trial regulations in India have affected some its studies
Vidya Krishnan , livemint.com
 
New Delhi: The National Institutes of Health (NIH), the state-owned medical research agency of the US, has finally confirmed that it has put on hold all clinical trials in India, following the health ministry’s efforts to tighten related laws.
“Recent clinical trial regulations in India have affected some NIH studies,” the NIH said in a 19 July statement. “Some trials have stopped enrolment and some others have been postponed.”
The NIH, an arm of the US health department, has cancelled approximately 40 ongoing clinical trials in the country, Mint reported on 11 July. NIH had declined comment at that time.
The health ministry relaxed some of the new rules it put in place, after realizing that these could effectively kill India’s growing clinical trials industry, according to a note posted on its website on 10 July. These tighter laws were instituted following the Supreme Court’s intervention.
The clinical trials business in India is estimated to be worth around $500 million (Rs.2,970 crore), according to researcher Frost and Sullivan, which projects that it will grow to $1 billion by 2016. Industry experts estimate a loss of $150-200 million in the past six months on account of regulatory changes.
After industry lobbying, the ministry has already relaxed norms—one concerning compensation and another that said the tests could have only the desired or intended effects, and no other.
India approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world, according to documents submitted by the Drugs Controller General of India in the Supreme Court, between January 2005 and June 2012.
The documents said that 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.
In a 3 January ruling, the apex court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the health secretary, who was asked to personally vet all approvals. Since then, only six trials had been approved until this month, when the ministry cleared 50 trials at one go.
“We believe the protection of research participants involved in clinical trials is an ethical imperative and we commend the substantial efforts being made to review the oversight of clinical trials in India,” the NIH said in its statement. “We are following developments surrounding the amendments to the Drugs and Cosmetics Rules, and are hopeful that additional information and guidance surrounding their implementation will pave the way for our continued joint endeavours.”

 

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