A diabetes drug which does not hurt your heart

BARCELONA: Mankind’s fight with diabetes and its associated medical complications goes back over 3,500 years ago. In fact, the earliest record of diabetes, written on a third dynasty Egyptian papyrus by physician Hesy-Ra , describes it as a “great emptying of the urine” .

Medical advances since then have progressed from treating diabetes with “wheat grains, fruit and sweet bee” to a host of integrated drugs, apart from a regimen of diet and exercise.

Currently, diabetes (both Type 1 and 2) affects an estimated 371 million people and kills over 4 million annually worldwide. Worryingly, over 63 million of these patients are found to be in India alone. Even more alarming is the correlation between diabetes and cardiovascular (CV) disease. Studies have shown that approximately 50% of diabetics die of a cardiovascular event.

As Dr Mark Kearney, professor of cardiovascular and diabetes research at the British Heart Foundation, University of Leeds, said: “If you are a South Asian, you are not only more susceptible to Type 2 diabetes but also to cardiac failure.” In fact, the cardiovascular age of a diabetic is pegged at 15 years more than the patient’s biological age. In simple terms, people with diabetes are four times more likely to die of a heart attack or stroke as compared to those who don’t have diabetes.

The main outlook in treatment of such patients is not to increase the risk of CV events even further. This is where data from Phase 3 trials in linagliptin, a DPP-4 inhibitor, holds out some sweet news. Boehringer Ingelheim and Eli Lilly and Company recently announced at the annual European Association for the Study of Diabetes meeting that treatment with linagliptin is not associated with increased risk of CV events in the treatment of T2D. Linagliptin (a 5mg tablet, once daily), is the only DPP-4 inhibitor that does not require dose adjustments in adults with T2D.

It is marketed as Trajenta in Europe and Tradjenta in the US. The results from the Phase 3 clinical trials of linagliptin, that covered 6,000 people with T2D in various countries, are even more heartwarming when its efficacy, safety and tolerability levels, especially among elderly patients, are considered.

(This correspondent was in Barcelona at the invitation of Boehringer-Ingelheim )

Childhood obesity: A problem of will and money

The American Heart Association recently published a sobering “scientific statement” on severe obesity among children and adolescents in the U.S. in their flagship journal, Circulation. The report, predictably spawning widespread attention in the popular press, suggests that by reasonable criteria, between 4 percent and 6 percent of our kids between the ages of 2 and 19 have severe obesity.

Those percentages probably don’t fully convey how common that makes this ominous condition. Consider that if a typical classroom held roughly 20 kids, there would be one “severely” obese child, on average, in every such classroom in the country. That is stunning, and extremely alarming — particularly given the current trends. Those trends, also noted in the report, indicate that severe obesity is “the fastest growing subcategory of obesity in youth.” Even where overall rates of obesity are leveling off, rates of severe obesity are rising briskly.

Our problems begin with our apparent inability to keep our eye on this ball. All too often, and at our collective peril, we treat scientific research like a Ping-Pong ball, diverting our attention first this way, then that. Media uptake of any given study often gives the impression that it represents the new, final word — replacing all we thought we knew before. But, of course, science is incremental; studies don’t replace one another, they contribute to the gradually accumulating weight of evidence. When we learn that rates of childhood obesity may be dipping slightly in some places, or leveling off among adults, it does not refute everything we knew about the outrageously high prevalence, the grave metabolic consequences, or the run-away increases in the most severe forms.

If virtually all of those vulnerable to obesity — adults and children alike — are already there, we can count on rates stabilizing. But if we are failing to help those who are already there from succumbing ever more fully,we can count on weights rising. It may no longer characterize the toll of epidemic obesity adequately to determine how many of us are overweight; that number may be relatively fixed now. We may need to ask: How overweight are the many of us? The American Heart Association gives us this answer about our kids: very.

This may explain why diabetes rates are rising on a truly ominous trajectory, even as overall obesity rates level off. More severe degrees of obesity are more predictive of metabolic complications and chronic disease, the details of just such associations occupying much of the new report’s verbiage.

But with the pages devoted to the new solutions we need, welcome and appropriate as this attention is, the AHA authors were far too conventional in my view. One of Albert Einstein’s famous witticisms is brought to mind: “We cannot solve our problems with the same thinking we used when we created them.”

We created the problem of epidemic obesity in children, and now hyper-endemic obesity in adults, over the past half century while propagating its causes in our culture and seeking its remedies in our clinics. But scalpels may be a very sorry substitute for the good that might be done in schools; pharmacotherapy may compare quite unfavorably to empowering better use of feet and forks.

Imagine looking at us from without, and assessing causes and cures of severe obesity informed by a dispassionate view from altitude. There would be a role for clinicians, clearly, but much of the relevant medicine would be cultural. Is it symptomatic of our inability to see outside the donut box that there is no mention in the new report, for instance, of aggressive food marketing to children?

The causes of obesity are not so much within us, as all around us. We and our kids are put together much the same ways we ever were, of course; yet the epidemiology of severe obesity is as it never was before. It takes change to produce change, and while our genes and physiologies are fairly constant, our culture is awash in obesigenic changes. Our plight is the predictable consequence.

There is a correspondingly predictable emphasis on drugs and surgery in the new report, and on models of clinical counseling. These are, indeed, appropriate for severe obesity — but they have severe liabilities.Drugs don’t tend to work very well. Surgery does, at least in the short term. But the costs are high; recidivism may be high as well. And surgery is something of a “deus ex machina” approach to obesity, doing nothing to address the factors that caused it in the first place. Surgery requires the skills of a surgeon but imparts no skills to the patient. Benefits we acquire under general anesthesia, whatever their duration, cannot be paid forward.

As for clinical counseling, consider its challenges. A child who is severely obese is generally caught up in a difficult dynamic at the family level. For a clinician to provide family counseling, appointments need to be scheduled for the whole family — a logistical challenge. If these appointments are during business hours, they pull adults away from work (assuming they are employed), and kids away from school. At best, the frequency of such encounters will be modest compared to the scope of the problem, and ill-suited to address some very practical concerns — such as no one in the home having the time, or skills, to prepare a meal.

Such challenges are further compounded by something we likely all know from personal experience, if not from the abundant research literature on the topic: Severely-obese kids are severely persecuted by their peers. When we were young, the “chubby” kid was the object of schoolyard bullying, to the regret of those of us victimized by it, and the shame of those of us who perpetrated it. Now, among kids who are chubbier in general than we were, it’s the severely “fat” kid who gets that daily dose of derision. That addition of insult to injury can lead to depression and despair, putting the behavior change needed for a remedy hopelessly out of reach. Can we really expect a doctor visit, even as often as once a month, to fix all of this?

There is something that can. We can embed solutions to severe obesity into the existing infrastructure of our lives and routines.

So, for instance, just as we have boarding schools to cultivate the talents of the academically gifted, or remediate the difficulties of the behaviorally challenged, so, too, could we have boarding schools for the severely obese, that blend academic rigor with comprehensive weight management. The appeal of such a concept, nowhere mentioned in the AHA report, is that severely-obese kids could get the intensity of treatment they need without stepping out of their lives to do so.

That treatment would almost certainly include behavioral, and psychological counseling. Depression and despair would need to be recognized and addressed by qualified professionals.

It would also include an emphasis on the relevant skills, such as identifying nutritious foods, learning how to choose and prefer them, and learning how to cook. It would include physical education and training, with an emphasis on strategies to fit fitness into every kind of daily routine. And by providing this and more in an environment where all the kids have run the same gauntlet, such a program could offer the therapeutic benefits of community, and compassion, and understanding.

And finally, if we could “fix” severe obesity in kids by empowering them with skills for healthy living, the kids could pay such benefits forward — to family members, and peers. Imagine re-integrating such kids into their public schools of origin, where their success at not just losing weight, but finding health — could inspire hope in others. Imagine such kids acting as peer mentors with a unique fund of knowledge and experience on which to draw.

And then stop imagining, because at least one such program exists. I have been privileged to serve as senior medical advisor to Mindstream Academy, which is the very model I’m describing. The results to date are stunning — with kids losing an average of nearly 50 pounds per semester, and some losing closer to 100. More important still is what the kids find: hope, self-esteem, and a renewed capacity to believe in themselves, and dream. And all of this is achieved by teaching a set of sustainable skills, not with any quick-fix gimmickry.

Why is the Mindstream model not more widely known, not mentioned in Circulation, and not accessible to the hundreds of thousands of kids who need it? In a word: money.

The families of severely-obese children tend to be the very families least able to afford treatment of any kind. Third-party payers can fix this, but they are accustomed to looking only at “medical” treatments. We tend to be rather blind to the possibility of lifestyle, or culture, as the medicine we need. But these are, in fact, the best medicines we’ve got – and with the potential to save us dollars along with lives.

Admittedly, we need to prove it. The Mindstream experience to date, for instance, needs to be published in the peer-reviewed literature; that’s in the works. We need to know more about the overall cost-effectiveness of such an approach, its sustainability, and how the program might be modified and still work. But we have routinely reimbursed for “medical” treatments before having such data. Even now, we know little about the long-term effects of bariatric surgery in tweens and teens. We might at the very least give school the same benefit of doubt we give scalpels.

There are many reasons why a problem that is hard but not truly complex, and amenable to remedies involving better use of feet and forks, has defied us for so long. We are inclined to medicalize obesity to legitimize it. But obesity as a “disease” implies a need for treatments of a clinical nature, drugs and surgery in particular. There are many good reasons why we do not have, and are unlikely to have, good drugs for obesity treatment. Surgery works, although just how long and how well for children, we really don’t know. But even if it worked well and sustainably, would we really want to sanction sending our sons and daughters through the operating room doors, to reorganize their gastrointestinal tracts, because we couldn’t manage to find ways to keep them from passing under the Golden Arches quite so often?

Even as we tear our proverbial beards, and gnash our teeth, we manage to turn a blind eye. Obesity is a cultural problem and requires a cultural solution we have the knowledge and means to administer. That we fail to apply those means — that we can watch television shows telling us of this threat to our kids, while our kids watching television are bombarded with intensive marketing of the very products that propagate the problem — bespeaks our ambivalence at best, our profit-driven hypocrisies at worst. Are we truly willing to mortgage the health of our children to fortify the corporate bottom line?

This is largely a problem of will, and money. Money, too, figures in the new report. The authors note that access to effective treatments for severe obesity is limited by lack of insurance coverage. In fact, the closing line of the article closes with a focus on dollars: “The task ahead will be arduous and complicated, but the high prevalence and serious consequences of severe obesity require us to commit time, intellectual capital, and financial resources to address it.”

Given the dire consequences of severe obesity left unaddressed, pecuniary neglect is at best penny-wise and pound-foolish. But given the prospects for losing far more than pennies as the pounds accumulate to rob our vulnerable daughters and sons of both years of life, and life in years, it is far worse than that. It is a colossal, collective cultural failure of the first order.

The new report speaks to the grave threat of severe obesity among our children and hints at the solutions we need. The solutions exist; the will to cultivate them seems to be in question. So, the words in this report are just a start. The question now is this: Will we put the needed money where these erudite mouths are?

David L. Katz is the founding director, Yale-Griffin Prevention Research Center.

Diabetes Ailing 114 Million Chinese Risks Ravaging Budget

Diabetes may consume $22 billion,
or more than half of China’s annual health budget, if all those
afflicted with the condition get routine, state-funded care.

The disease is putting an “overwhelming burden” on the
country, according to the International Diabetes Federation,
which says China spent $17 billion, or about $194 a patient, on
diabetes last year. A study released last week found China has
114 million diabetics or 21.6 million more than the Brussels-based federation estimated in November.

Extending average care to the enlarged population of
diabetes sufferers would wipe out all of China’s additional
investment in health. The government budgeted spending 260.25
billion yuan ($42.5 billion) this year, a 27 percent increase,
on basic medical services and subsidies for a state-run health
insurance program. China’s diabetes costs will balloon, with
almost 500 million Chinese at risk of developing the disease.

“It’s very scary,” said T.H. Lam, a professor of public
health at the University of Hong Kong. “This only represents
the beginning of the diabetic epidemic. The worst is yet to
come.”

Diabetes costs an average of $1,270 per patient globally
and $8,478 in the U.S., according to the International Diabetes
Federation
. Treatment for the metabolic condition and its
associated ailments is expensive because patients with poor
blood-sugar control can develop complications ranging from heart
disease
and stroke to gangrenous foot ulcers, blindness and
kidney failure.

Oblivious Diabetics

The most comprehensive nationwide survey for diabetes ever
conducted in China showed 11.6 percent of adults have the
disease. The study, published Sept. 3 in the Journal of the
American Medical Association
, also found that almost two-thirds
of patients treated for diabetes in China don’t have adequate
blood-sugar control and that for every person diagnosed with the
condition, at least two more will be unaware they have it.

“People with diabetes who are not under treatment or have
good control of their diabetes will quickly start to develop
complications,” said Leonor Guariguata, a biostatistician at
the International Diabetes Federation. “We know from studies in
Europe that the first cardiovascular complication in a person
with diabetes can increase the per-person annual costs
associated with the disease by at least 50 percent and by 360
percent for a major cardiovascular event, such as heart attack
or stroke.”

$500 Billion Cost

Type-2 diabetes prevalence is expanding 4 percent a year
globally, compared with 1-to-2 percent for obesity, resulting in
$500 billion in medical costs, or more than 10 percent of
health-care expenditure, the Credit Suisse Research Institute
said yesterday in a report. Ninety percent of doctors worldwide
surveyed by the institute believe the type-2 diabetes and
obesity epidemics are linked to excess sugar consumption.

“As with alcohol and tobacco, higher taxation on drinks is
the best option to reduce sugar intake and help fund the fast
growing health-care costs,” the report said.

Most of China’s diabetes sufferers have the type-2 form,
which occurs when the body stops responding adequately to
insulin, the hormone that regulates blood-sugar. Type-1
diabetes, prevalent in about 5 percent of all sufferers, is an
autoimmune disease that results from the destruction of the
body’s insulin-producing beta cells in the pancreas.

China’s diabetes prevalence is being spurred by diet and
lifestyle changes linked to the country’s economic development,
which have resulted in an increasingly overweight and obese
population, said Barry Popkin, a professor in the department of
nutrition at the University of North Carolina at Chapel Hill,
who has studied weight trends in China.

‘Tip of the Iceberg’

“This is just the tip of the iceberg,” Popkin said in an
interview. “We’re beginning to see a whole cohort of younger
Chinese that are heavier, have greater rates of obesity as well
as diabetes, and in the future this is going to go way up.”

Chinese aged 10 to 30 are about 6-7 kilograms (15 pounds)
heavier than that age group 20 years ago, mainly due to
inactivity, and diets that comprise more sugary drinks, alcohol,
refined rice, and less fiber, Popkin said. This puts them at
higher risk of developing diabetes, he said.

Half of China’s adults, or 493.4 million people, have
higher-than-normal blood-glucose levels, which put them in a
pre-diabetic state that triples their risk of full-blown
diabetes, said Guang Ning, lead author of last week’s study and
director of the National Health and Family Planning Commission’s
laboratory for endocrine and metabolic diseases.

Cheaper Treatments

“China is trying hard to control the cost of treating
diabetes as much as possible,” said Ning, who is also head of
endocrinology and metabolism at the Rui-Jin Hospital in
Shanghai. “We have been able to do this by reducing the cost of
drugs and by encouraging more people to get treatment locally.”

Thirty-five percent of Chinese citizens’ health-care costs
were paid “out-of-pocket” in 2011, down from 58 percent in
2002, after the government expanded subsidies, according to a
State Council report published in December.

China’s doctors are encouraged to prescribe the generic
medicine metformin as a first-line drug for diabetics, while
patients who prefer traditional remedies are given huang lian su
tablets, containing berberine, a plant extract shown to be
effective in treating Type 2 diabetes, Ning said. Both these
options are much cheaper than imported medicines, he added.

“The major way to reduce the economic burden is to have a
good primary care system so many of these people can be treated
there, reducing the hospital expenditure,” said the University
of Hong Kong’s Lam. “There is a golden opportunity for early
treatment or early prevention to make sure people can reduce
their risk.”

To contact Bloomberg News staff for this story:
Daryl Loo in Beijing at
dloo7@bloomberg.net;
Natasha Khan in Hong Kong at
nkhan51@bloomberg.net

To contact the editor responsible for this story:
Jason Gale at
j.gale@bloomberg.net


Enlarge image
Diabetes Hospital

Diabetes Hospital

Diabetes Hospital

Wang Zhao/AFP/Getty Images

A woman waits to receive treatment as she sits in front of billboards about diabetes at a diabetes hospital in Beijing.

A woman waits to receive treatment as she sits in front of billboards about diabetes at a diabetes hospital in Beijing. Photographer: Wang Zhao/AFP/Getty Images


China's Diabetes ‘Catastrophe’ Afflicts 114 Million

Sept. 4 (Bloomberg) — The most comprehensive nationwide survey for diabetes ever conducted in China shows 11.6 percent of adults, or 114 million, has the disease. The finding, published yesterday in the Journal of the American Medical Association, adds 22 million diabetics, or the population of Australia, to a 2007 estimate and means almost one in three diabetes sufferers globally is in China. Stephen Engle reports. (Source: Bloomberg)

Oregon Faith-Healing Parents Charged With Manslaughter In Daughter's Death …

On Friday, Travis and Wenona Rossiter were brought before a judge in Linn County, Ore., and plead not guilty to charges of manslaughter for their daughter Syble’s death. In February, the 12-year-old girl died in their home because of complications due to type 1 diabetes. She did not receive medical treatment for the condition.

“The 12-year-old had a treatable medical condition and the parents did not provide adequate and necessary medical care to that child,” said local police Captain Eric Carter. “And that, unfortunately, resulted in the death of her on February 5 of this year.”

Although unconfirmed, the couple is rumored to have withheld medical treatment in favor of faith-based healing.

The Rossiters attend the Church of the First Born, a church that allegedly encourages its members to seek faith-based interventions for illnesses instead of modern medical treatment. Its website cites biblical verse James 5:14, “If any be sick, call for the elders of the church, let them pray over him, anointing him with oil in the name of the Lord.”

Syble suffered from type 1 diabetes, formerly known as juvenile diabetes, a condition in which a person is unable to produce insulin. Without insulin therapy, type 1 diabetes is fatal. The most common cause of death among pediatric diabetics is diabetic ketoacidosis. Resulting from the buildup of fat metabolites called ketones, diabetic ketoacidosis  is characterized by vomiting, dehydration, confusion, and eventually leads to coma and death if left untreated. The clinical details of Syble’s death have not been made public.

With insulin therapy administered through injections or an insulin pump, people with type 1 diabetes can live nearly as long as the general population. 

The church websites explains that its members should comply with local health officials. “If you choose not to take your child to a doctor, then we urge you to immediately notify the county health department and the state department of human services using our corporate forms.”

Tragically, if the Rossiters are found guilty, they would not be the first parents deemed liable in the death of a child within the church. In 2012, Brandi and Russel Bellew, also of the Church of the first Born, pleaded guilty to criminally negligent homicide after their son, Austin Sprout Creswell, died at age 16 from an untreated infection secondary to a burst appendix. At least 22 children associated with the Church of the First Born have died from lack of medical treatment since 1964, according to the group Children’s Healthcare Is a Legal Duty.

A neighbor interviewed by local CBS affiliate KOIN 6 News described Syble as a quiet girl who enjoyed riding her bike. “She seemed shy to talk to people because they picked apples out of my yard,” the neighbor said.

“Personalised treatment for diabetes is the future”

Personalised therapy for diabetes is the way forward, says William T.Cefalu, editor-in-chief, Diabetes Care, an international peer-reviewed journal of the American Diabetes Association.

“We have, at our disposal, many new drugs. The thing now, is how do we personalise therapy? ” Dr. Cefalu asks. “There is no one set way to treat every patient, instead we must be treating every patient individually. Based on the duration of the disease, ability to detect hypoglycaemia [low sugar], adherence to treatment protocols, and compliance, we can work out treatment strategies for each patient, depending on his co-morbid conditions,” he tells The Hindu in an interview, during his recent brief visit to Chennai.

Dr. Cefalu, who is also Chief, Endocrinolgy, Diabetes and Metabolism, Louisiana State University Health Sciences Center, New Orleans, stresses the urgency in diagnosing the condition early. “Diabetes is a progressive disease, and pre diabetes is associated with obesity, and it is important to recognise it early. It is the complications we are concerned about: blindness, cardio vascular disease, kidney disease,” he says. It is important first and foremost because of the huge burden on society, and as far as the costs of treating diabetes goes, takes a toll on the finances and emotions of the patient and his/her family.

Dr. Cefalu was in Chennai to deliver the 21st Dr. Mohan’s Diabetes Specialties Gold Medal Oration. His advice is to professionals to go at diabetes with all guns blazing. “The evidence is pretty clear: tackling glucose control and risk factors aggressively definitely have a good effect,” he says, countering critics who accuse diabetologists of ‘over-treating’ the condition. While, at the pre-diabetes stage, it is possible to prevent progression into diabetes, it is also possible to prevent complications that can oftentimes be fatal.

Focussing on the key question of the play of environment and genes in causing diabetes, Dr. Cefalu is very clear that lifestyle does play a major role. Of late, diabetologists have noticed an increase in childhood obesity and, Type 2 diabetes among this group, he adds. “Diabetes in children may be in a little more aggressive form. What is appropriate for them? As children grow and mature, it becomes difficult assessing the right balance.” However, advocating for a healthy lifestyle – diet and packing greater activity into a day is important.

In addition to new drugs, a lot of exciting new possibilities await the future of treatment of diabetes, Dr. Cefalu says. “A lot of work is happening in the area of islet cells transplants; some procedures have been done. The other exciting area is in artificial pancreas, where there has been significant progress. Also, the questions of what we do with bariatric surgery and at what point we intervene will be decided over the next few years.”

Diabetes drug back with warning, but will patients swallow the pill?

Govt directive warns that Pioglitazone should not be first line of therapy

Diabetes drug pioglitazone and its combinations are back, but with a box warning in “bold red letters” to caution patients.

For a drug suspended a month ago for its possible links to urinary bladder cancer, its revocation could end up being a tough pill to swallow, especially for new patients with type II diabetes, say doctors.

Patients who have controlled diabetes with pioglitazone may still go back to the drug, says diabetologist Rajiv Kovil.

But putting new patients on pioglitazone may fall by at least two-thirds, he says, as they would be “extremely anxious”.

An engineer by profession, 43-year-old Rishi Kumar, for instance, would not like to take the medicine, now that he has doubts about its safety. He would, in fact, go for a second opinion if he is prescribed the medicine again.

Warnings

Pioglitazone is used as a third line of treatment. In its latest directive, the Government has emphasised the need for caution, insisting that the drug not be used as the first line of therapy, says Kovil.

The Government has brought back pioglitazone with several riders. Doctors need to run tests on the patient before initiating treatment, restrict use of the drug in elderly patients and prescribe it only after knowing the patient’s history.

It also requires patients on pioglitazone to be put through 3-6 monthly reviews.

Diabetologist V. Mohan is happy that, after much discussion, the Government has laid down several conditions on the use of pioglitazone. He was also involved in the discussions on pioglitazone and its suspension.

Patients will go by what the doctor says, and the doctor needs to share all these risks with the patient before starting the drug, he points out.

Precisely the sentiment of 69-year-old A.N. Dutta, suffering from type-2 diabetes for 10 years.

“I would not like to second-guess my doctor on this issue. Ultimately, it is about having faith in your doctor’s judgment. Now that the ban has been revoked, if he prescribes the medicine (piloglitazone) again, I will take it,” he says.

jyothi.datta@thehindu.co.in

aesha.datta@thehindu.co.in

FDA serves bitter pill to alternative diabetes treatment

Separately, in a case unrelated to diabetes crackdown, the Indian pharma major Wockhardt was also issued a notice for a range of violations, from manufacturing defects and poor training of personnel to inadequate toilet facilities.

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the July 18 letter warned Wockhardt chairman Habil Khorakiwala, accusing the company of impeding FDA inspectors at its Aurangabad plant.

Wockhardt joins Ranbaxy, Sun Pharma, RPG Life Sciences among Indian drug companies that have come under FDA scrutiny for violations that range from poorly trained personnel, to dodgy record keeping, to stinky toilets.

But it was the diabetes medication crackdown that sent shock waves through the industry, because the market for alternative diabetes remedies has grown hugely in the past decade. Sales of diabetes medication has increased 60 per cent — from $14 billion to $22 billion — in the last four years alone, as the world, from developed countries such as U.S to developing nations like India, have gotten sucked into a sugar-starch overdose.

There are some 30 million diabetes patients in the U.S and upward of 60 million in India (out of a world total of 300 million diabetes victims), making the two countries a lucrative market for western Big Pharma. Increasingly, diabetes patients are looking for alternative remedies, but the FDA clearly disapproves that route.

“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments. Consumers who buy volatile products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” FDA Commissioner Margaret A. Hamburg said in a statement.

Medications cited in the ban order included unapproved versions of metformin and Januvia, which is procured from India and sold online in the U.S., and Diexi, manufactured by Amrutam LifeCare of Surat. Amrutam was also cited for dodgy claims with regards to supplements such as Zoom (for erectile dysfunction), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).

The FDA letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take it without knowing that it can cause serious harm or interact in dangerous ways with other drugs.

For example, the letter to Amrutam said, “By marketing your products ‘Diexi’ and ‘Zoom’ as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading.”

FDA serves bitter pill to alternative diabetes treatment

WASHINGTON: The US Food and Drug administration has cracked down on what are widely considered alternative or natural treatment for diabetes, including ayurvedic and homeopathic remedies. Fifteen companies in the US, including some that procure alternative diabetes medications from India, have been served warning letters by the FDA, asking them to stop sale in the US of products claiming to treat, cure, and prevent diabetes.

Separately, in a case unrelated to diabetes crackdown, the Indian pharma major Wockhardt was also issued a notice for a range of violations, from manufacturing defects and poor training of personnel to inadequate toilet facilities.

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the July 18 letter warned Wockhardt chairman Habil Khorakiwala, accusing the company of impeding FDA inspectors at its Aurangabad plant.

Wockhardt joins Ranbaxy, Sun Pharma, RPG Life Sciences among Indian drug companies that have come under FDA scrutiny for violations that range from poorly trained personnel, to dodgy record keeping, to stinky toilets.

But it was the diabetes medication crackdown that sent shock waves through the industry, because the market for alternative diabetes remedies has grown hugely in the past decade. Sales of diabetes medication has increased 60 per cent — from $14 billion to $22 billion — in the last four years alone, as the world, from developed countries such as U.S to developing nations like India, have gotten sucked into a sugar-starch overdose.

There are some 30 million diabetes patients in the U.S and upward of 60 million in India (out of a world total of 300 million diabetes victims), making the two countries a lucrative market for western Big Pharma. Increasingly, diabetes patients are looking for alternative remedies, but the FDA clearly disapproves that route.

“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments. Consumers who buy volatile products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” FDA Commissioner Margaret A. Hamburg said in a statement.

Medications cited in the ban order included unapproved versions of metformin and Januvia, which is procured from India and sold online in the U.S., and Diexi, manufactured by Amrutam LifeCare of Surat. Amrutam was also cited for dodgy claims with regards to supplements such as Zoom (for erectile dysfunction), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).

The FDA letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take it without knowing that it can cause serious harm or interact in dangerous ways with other drugs.

For example, the letter to Amrutam said, “By marketing your products ‘Diexi’ and ‘Zoom’ as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading.”

The bittersweet truth about diabetes

With the central government putting a ban on anti-diabetic drug pioglitazone close to a week ago, medication expenses of diabetics who were on the drug are set to rise. “While a pioglitazone tablet cost Rs4-Rs8, patients who were using the drug will now have to shift to costlier options like gliptin, which cost upto Rs50 per tablet or insulin, each vial of which costs between Rs150-Rs500,” said Dr Siddarth Shah, diabetologist, SL Raheja Hospital in Mahim.

Doctors said that up to 30 lakh people suffer from Type 2 diabetes in the country, the result of a lifestyle that is said to be faulty. Of these 20%  are on standalone or a combination of drugs including pioglitazones.

“We are appealing to patients that they should immediately consult their physicians for alternative lines of treatment. Pioglitazones were excellent insulin sensitizers. However, patients with weak hearts or elderly patients were not given pioglitazone due to side effects like weight gain and congestive heart failure,” said Shah. “In young patients, however, the drug in smaller doses worked well.”

After the ban all drugs containing pioglitazone as an ingredient have gone off the shelf in chemist shops. The central government has banned the drug citing a possible link between pioglitazone and bladder cancer. “The drug has gradually been phased out in France due to a potential risk of bladder cancer. However, even US continues to use the drug, albeit with a black box warning listing the health risks that the drug poses,” said Dr Vijay Pannikar, diabetologist, Lilavati Hospital, Bandra.

Doctors believe that the blanket ban on pioglitazones by the central government is premature. “Instead of imposing an outright ban on the drug, an expert committee ought to have been formed to study the pros and cons of using the drug. More so, the sale of the drug can be regulated by putting it in scheduled category so that it is available on specialised prescription from an endocrinologist or a diabetologist,” said Dr Shashank Joshi, president, Indian Academy of Diabetes.

With the ban on pioglitazones, diabetics may have to shell out more money for diabetes treatment but time-tested alternatives are available, said doctors, allaying fears.

“Metformin, Sulphonyureas and Insulin are time tested alternatives. Moreover, with pharmacy practices in India not up to the mark, pioglitazones were easily available to patients. Diabetics are more prone to develop side effects due to pioglitazones which may have gone unnoticed due to their easy availability,”said Joshi.