US FDA starts to stamp out Indian bidis

[Ray]

US FDA starts to stamp out Indian bidis

WASHINGTON: The US Food and Drug Administration (FDA) on Friday banned four kinds of bidis from a little-known company in India as part of a renewed American effort to stamp out unregulated import of dangerous tobacco products under new authority vested in the agency.

Just days after FDA commissioner Margaret Hamburg returned from India, agency officials announced that four bidi brands made by Jash International — Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone — may no longer be domestically sold, distributed or imported.

The bidis were banned not because of any imminent danger — although it is well-known that all tobacco products are dangerous — but because Jash failed to provide ingredient information that is mandatory under new rules.

In a conference call on Friday, not specifically related to the bidi issue, commissioner Hamburg denied the FDA was targeting Indian companies, but said the United States has a strict quality control regime for all products being imported into America.

''When products are sold in the United States for use by American citizens, then those products have to meet our regulatory standards and requirements and we inspect those facilities in other countries as well," she told reporters after her first official trip to India, where FDA action against India-based pharmaceutical companies have been the focus of attention.

But US efforts to stamp out bidi imports and smoking in America has a history going back some two decades when the Indian mini-cigarette started to become a fad among youth after hippies had first lit them up in the sixties. A 2002 survey showed close to 3% of American male high school students had tried bidis, which, because they were largely unregulated, were easier for the youth to access — particularly after the US cracked down on sale of cigarettes to the under-aged.

Over the last decade, bidis also began to appear in various all-American, candy-like flavors: chocolate, vanilla and strawberry, adding newer flavors such as grape, cinnamon, watermelon, menthol, black licorice, wild cherry, and mandarin orange, as the craze caught on. No accurate figures are available about the extent of bidi imports from India but estimates by an international trade group in the 1990s put import from India at 448 million pieces valued at less than $5 million.

The Clinton administration tried to ban import of beedis around that time after a CBS 60 Minutes program showed child labor in the industry that employs an estimated 3 million people in India. But it was never fully carried through.

The health and economic cost of smoking is something that has seized developed countries even as developing countries continue to get sucked into western-inspired tobacco consumption that is far more lethal and pervasive than bidi imports to America.

A 2010 WHO study estimated that smoking in developed countries will amount to 29% of world tobacco consumption (down from 34% in 1998), while developing countries' share, now said to be growing at around 3% every year, will be 71%. Some six million people die every year from tobacco-related illness — 80% of them in low-income countries.

US FDA starts to stamp out Indian bidis - The Times of India

*************************************************

All tobacco products are harmful.

But what is interesting is that the FDA did not ban the bidis because they were injurious to health, but because failed to provide ingredient information that is mandatory under new rules!!

Bureaucracy the world over have brains in the wrong part of their anatomy!

Through this article I came to know that there are so many types of bidis with exotic flavours!

 

[pmaitra]

Bidis are far safer than the chemical laced cigarettes sold in the US. Someone should call the FDA out on this one.

 

[thethinker]

It's all about pharma corporate interests, FDA is just a middleman of sorts.

Risky Drugs: Why The FDA Cannot Be Trusted

Full article:

A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME), edited by Marc Rodwin and supported by the Edmond J. Safra Center for Ethics, presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs.

All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.

The bar for "safe" is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm,1 while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.

Prescription drugs are the 4th leading cause of death. Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total. American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.

The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. New FDA policies are likely to increase the epidemic of harms. This will increase costs for insurers but increase revenues for providers.

This evidence indicates why we can no longer trust the FDA to carry out its historic mission to protect the public from harmful and ineffective drugs. Strong public demand that government "do something" about periodic drug disasters has played a central role in developing the FDA.2 Yet close, constant contact by companies with FDA staff and officials has contributed to vague, minimal criteria of what "safe" and "effective" mean. The FDA routinely approves scores of new minor variations each year, with minimal evidence about risks of harm. Then very effective mass marketing takes over, and the FDA devotes only a small percent of its budget to protect physicians or patients from receiving biased or untruthful information.3 4 The further corruption of medical knowledge through company-funded teams that craft the published literature to overstate benefits and understate harms, unmonitored by the FDA, leaves good physicians with corrupted knowledge.5 6 Patients are the innocent victims.

Although it now embraces the industry rhetoric about "breakthrough" and "life-saving" innovation, the FDA in effect serves as the re-generator of patent-protected high prices for minor drugs in each disease group, as their therapeutic equivalents lose patent protection. The billions spent on promoting them results in the Inverse Benefit Law: the more widely most drugs are marketed, the more diluted become their benefits but more widespread become their risks of harm.

The FDA also legitimates industry efforts to lower and widen criteria prescribing drugs, known by critics as "the selling of sickness." Regulations conveniently prohibit the FDA from comparing the effectiveness of new drugs or from assessing their cost-effectiveness. Only the United States allows companies to charge what they like and raise prices annually on last year's drugs, without regard to their added value.7

A New Era?

Now the FDA is going even further. The New England Journal of Medicine has published, without comment, proposals by two senior figures from the FDA to loosen criteria drugs that allege to prevent Alzheimer's disease by treating it at an early stage.8 The authors seem unaware of how their views about Alzheimer's and the role of the FDA incorporate the language and rationale of marketing executives for the industry. First, they use the word "disease" to refer to a hypothetical "early-stage Alzheimer's disease" that supposedly exists "before the earliest symptoms of Alzheimer's disease are apparent." Notice that phrasing assumes that the earliest symptoms will become apparent, when in fact it's only a hypothetical model for claiming that cognitive lapses like not remembering where you put something or what you were going to say are signs of incipient Altzheimer's disease. The proposed looser criteria would legitimate drugs as "safe and effective" that have little or no evidence of being effective and expose millions to risks of harmful side effects.

No proven biomarkers or clinical symptoms exist, the FDA officials note, but nevertheless they advocate accelerated approval to allow "drugs that address an unmet medical need." What "unmet need"? None exists. This market-making language by officials who are charged with protecting the public from unsafe drugs moves us towards the 19-century hucksterism of peddling cures of questionable benefits and hidden risks of harm, only now fully certified by the modern FDA.9

The main reason for advocating approvals of drugs for an unproven need with unproven benefits, these FDA officials explain, is that companies cannot find effective drugs for overt Alzheimer's. Their drug-candidates have failed again and again in trials. The core rationale of the proposed loosening of criteria is that "the focus of drug development has sifted to earlier stages of Alzheimer's disease"¦and the regulatory framework under which such therapies are evaluated should evolve accordingly." Yet they admit there are no "therapies" in this much larger market where (with the help of the industry-funded FDA) companies will not have to prove their drugs are effective. In fact, these FDA officers propose to approve the drugs without ever knowing if they are therapeutic or not. Their commercialized language presumes the outcome before starting. The job of the FDA, it seems, is to help drug companies open up new markets to increase profits for the FDA's corporate paymasters.

These two FDA officials maintain that "the range of focus must extend to healthy people who are merely at risk for the disease but could benefit from preventive therapies." Yet they admit we do not know who is "at risk," nor whether there is a "disease," nor whether anyone "could benefit," nor whether the drugs constitute "preventive therapies." Similar FDA-encouraged shifts have been made for drugs treating pre-diabetes, pre-psychosis, and pre-bone density loss, with few or no benefits to offset risks of harm. This week, based on policy research at the Edmond J. Safra Center for Ethics, a letter of concern was published in the New England Journal of Medicine. The authors write that approval for drugs to treat "early stage Altzheimer's disease" must meet "a much higher bar – evidence of slowed disease progression." But without clinical manifestations or biomarkers for an alleged disease, how will such progression be measured?

Advice to readers: Experienced, independent physicians recommend not to take a new drug approved by the FDA until it is out for 7 years, unless you have to, so that evidence can accumulate about its real harms and benefits.10

----

 

[W.G.Ewald]

Bidis are far safer than the chemical laced cigarettes sold in the US. Someone should call the FDA out on this one.

Try American Spirit cigs.

 

[mattster]

Try American Spirit cigs.

Actually the bidis that are sold on the street in Kerala are pretty darn good.

Here in the US my cig of choice is a Dunhill......far better taste than American spirit.
Nat Sherman is good too.....but both are expensive and only certain stores carry them.

 

[pmaitra]

Try American Spirit cigs.

You should see this movie, if you have not already: The Insider (film) - Wikipedia, the free encyclopedia

 

[Ray]

Be a Man

Poor chap he died recently after years of being a Man!

 

[W.G.Ewald]

You should see this movie, if you have not already: The Insider (film) - Wikipedia, the free encyclopedia

I did not see it, don't remember hearing about it. What was more important though were probably the lawsuits brought against tobacco companies by smokers.

Smoker's widow wins $3.8 million in lawsuit against tobacco... | www.palmbeachpost.com