February 27, 2012
By Mark Hyman. M.D.
This week, in an act of desperation to turn back the tide of the obesity epidemic that now affects almost seven out of every 10 Americans and more than 80 percent of some populations (African-American women), the advisory committee to the Food and Drug Administration (FDA) voted 20 to 2 to recommend approval of Qnexa, a “new” obesity drug that is simply the combination of two older medications, phentermine (the “phen” of phen-fen”) and topiramate (Topamax).
It is a misguided effort at best, and a dangerous one at worst. Mounting evidence proves that the solution to lifestyle and diet-driven obesity-related illnesses including heart disease, diabetes, dementia, and even cancer won’t be found at the bottom of a prescription bottle.
By 2020, more than 50 percent of the U.S. adult population will have Type 2 diabetes or prediabetes, with annual costs approaching $500 billion. By 2030, total annual economic costs of cardiovascular disease in the U.S. are predicted to exceed $1 trillion. By 2030, globally we will spend $47 trillion, yes trillion, to address the effects of chronic lifestyle-driven disease.
Prescription medication for lifestyle disease has failed to bend the obesity and disease curve. Statins have been recently found to increase the risk of diabetes in women by 48 percent. And large data reviews by independent international scientists from the Cochrane Collaborative found that statins only work to prevent second heart attacks, not first heart attacks, which means they are not helpful and most likely harmful for 75 percent of those who take them.
Avandia, the No. 1 blockbuster drug for Type 2 diabetes, has caused nearly 200,000 deaths from heart attacks since it was introduced in 1999. The drug was designed to prevent complications of diabetes, yet heart attacks are the very disease that kills most Type 2 diabetics. In 2011, the FDA issued stricter prescribing guidelines for Avandia, but the drug is still on the market.
The large ACCORD trial found in more than 10,000 diabetics that intensive blood-sugar lowering with medication and insulin actually led to more heart attacks and deaths.
Something is deeply wrong with our medical approach.
The problem of chronic disease, including obesity, diabetes, and heart disease, is not a medication deficiency, but a problem with what we put at the end of our fork.
The emperor truly has no clothes. Why would good men and women of science vote to approve a medication for a condition that is a social disease and requires a social cure? The social, environmental, economic, and political conditions of America and increasingly the global community have created an obesogenic environment.
Clearly we need to do something. But it is not better medication or surgery or more angioplasties and stents, which have no proven benefit in more than 90 percent of those who receive them. The data show they work for acute coronary events, but not stable angina or blockages.
We continue to pay for expensive treatments for chronic disease, despite the fact that they don’t work, while insurance does not pay for nutrition counseling unless the patient has kidney failure or diabetes.
Chronic disease is a food-borne illness. We ate our way into this mess and we must eat our way out.
December 6, 2011
By Ethan A. Huff
“So GSK makes $43 billion profit and the government fines them $3 billion. It’s a win/win for GSK. The real question is why the CEO of the company is not in jail?” –KTRN
The pharmaceutical industry is notorious for getting away with murder, both figuratively and literally, without so much as a slap on the wrist from the justice system. And a recent settlement involving drug giant GlaxoSmithKline (GSK) only further exposes the fact that Big Pharma is free to break the law as long as it pays off Big Government, its partner in crime.
The latest dog and pony show involves the US government addressing GSK’s illegal activity over the years in peddling its deadly chemical cocktails. After being exposed for illegally marketing drugs, paying off doctors to promote dangerous drugs, and manipulating scientific data to get dangerous drugs approved, GSK has essentially been pardoned by the US government in exchange for $3 billion.
Sure, $3 billion might sound like a lot of money to most people. But GSK raked in roughly $43 billion in revenue just last year. So this settlement is a mere drop in the bucket for GSK, and it really does nothing to satisfy the demands of justice. It does, however, conveniently transfer $3 billion in payoff money to the federal government, which has allowed GSK to get away with its crimes for years.
NaturalNews readers will recall the 2010 Senate Finance Committee report that exposed GSK for deliberately hiding evidence about the dangers of its diabetes drug Avandia. The US Food and Drug Administration (FDA) worked hand-in-hand with GSK to downplay Avandia’s dangers, effectively preserving billions of dollars in yearly revenue for GSK from the sale of the “blockbuster” drug (http://www.naturalnews.com/028233_G…).
There are literally tens of thousands of lawsuits currently pending against GSK over Avandia, not to mention countless known instances of the company’s blatant criminal activity in marketing it. But did the FDA ever decide to pull Avandia from the market to protect consumers? Of course not. And there is no indication that any of GSK’s executives will be held personally responsible for such crimes, either.
“Who at Glaxo is going to jail as a part of this settlement?” asked Patrick Burns, spokesman for Taxpayers Against Fraud, an advocacy group for whistleblowers. “Who in management is being excluded from doing future business with the US government?”
Welcome to the Dr. Trudeau Show! KT explains what it will take to cure all your illnesses! (Disclaimer: Kevin Trudeau is not a medical doctor) Plus, Blake Sawyer of Royal Velvet stops by the show to explain exactly how deer antler velvet can act as the fountain of youth and turn back the hands of time! Click here to find out why professional athletes buy this product in bulk!
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FDA’s Big Drug Problem
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Osteoporosis Drug Likely To Cause Cancer
FDA Calls Lung Drug Misleading
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October 19, 2011
By Mark Hyman, MD
Do vitamins kill people?
How many people have died from taking vitamins?
Should you stop your vitamins?
It depends. To be exact, it depends on the quality of the science, and the very nature of scientific research. It is very hard to know things exactly through science. The waste bin of science is full of fallen heroes like Premarin, Vioxx and Avandia (which alone was responsible for 47,000 excess cardiac deaths since it was introduced in 1999).
That brings us to the latest apparent casualty, vitamins. The recent media hype around vitamins is a classic case of drawing the wrong conclusions from good science.
Remember how doctors thought that hormone replacement therapy was the best thing since sliced bread and recommended it to every single post-menopausal woman? These recommendations were predicated on studies that found a correlation between using hormones and reduced risk of heart attacks. But correlation does not prove cause and effect. It wasn’t until we had controlled experiments like the Women’s Health Initiative that we learned Premarin (hormone replacement therapy) was killing women, not saving them.
A new study “proving” that vitamins kill people is hitting front pages and news broadcasts across the country. This study does not prove anything.
This latest study from the Archives of Internal Medicine of 38,772 women found that “several commonly used dietary vitamin and mineral supplements may be associated with increased total mortality”. The greatest risk was from taking iron after menopause (which no doctor would ever recommend in a non-menstruating human without anemia).
The word “may” is critical here, because science is squirrelly. You only get the answers to the questions you ask. And in this case, they asked if there was an association between taking vitamins and death in older woman. This type of study is called an observational study or epidemiological study. It is designed to look for or “observe” correlations. Studies like these look for clues that should then lead to further research. They are not designed to be used to guide clinical medicine or public health recommendations. All doctors and scientists know that this type of study does not prove cause and effect.
Why Scientists are Confused
At a recent medical conference, one of most respected scientists of this generation, Bruce Ames, made a joke. He said that epidemiologists (people who do population-based observational studies) have a difficult time with their job and are easily confused. Dr. Ames joked that in Miami epidemiologists found everybody seems to be born Hispanic but dies Jewish. Why? Because if you looked at population data in the absence of the total history and culture of Florida during a given time, this would be the conclusion you would draw. This joke brings home the point that correlation does not equal causation.
Aside from the fact that it flies in the face of an overwhelming body of research that proves Americans are nutrient deficient as a whole, and that nutritional supplements can have significant impact in disease prevention and health promotion, the recent study on vitamins is flawed in similar ways.
How Vitamins Save Money and Save Lives
Overwhelming basic science and experimental data support the use of nutritional supplements for the prevention of disease and the support of optimal health. The Lewin Group estimated a $24 billion savings over 5 years if a few basic nutritional supplements were used in the elderly. Extensive literature reviews in the Journal of the American Medical Association and the New England Journal of Medicine also support this view. Interventional trials have proven benefit over and over again.
The concept that nutritional supplements “could be harmful” to women flies in the face of all reasonable facts from both intervention trials and outcome studies published over the past 40 years. Recent trials published within the last two years indicate that modest nutritional supplementation in middle age women found their telomeres didn’t shorten. Keeping your teleomeres (the little end caps on your DNA) long is the hallmark of longevity and reduced risk of disease.
A plethora of experimental controlled studies — which are the gold standard for proving cause and effect — over the last few years found positive outcomes in many diseases. These include the use of calcium and vitamin D in women with bone loss; folic acid in people with cervical dysplasia (pre-cancerous lesions); iron for anemics, B-complex vitamins to improve cognitive function, zinc; vitamin C, E, and carotenoids to lower the risk of macular degeneration, and folate and vitamin B12 to treat depression. This is but a handful of examples. There are many more.
Why Most Vitamin Studies are Flawed
There is another important thing to understand about clinical trials that review the utility of vitamins in the treatment of disease. The studies that show harm are often designed like drugs studies. For example, a study may use a high dose of vitamin E and see what happens. This is actually a prescient example also explored in recent media. Studies recently found that high doses of vitamin E and selenium didn’t prevent prostate cancer and may increase risk. What this study didn’t explore properly was the true biochemical nature of vitamin E and selenium. These nutrients work as antioxidants by donating an electron to protect or repair a damaged molecule or DNA. Once this has happened the molecules become oxidants that can cause more damage if not supported by the complex family of antioxidants used in the human body. It’s sort of like passing a hot potato. If you don’t keep passing it you will get burned. This study simply failed to take this into account.
Nature doesn’t work by giving you only one thing. We all agree that broccoli is good for you, but if that were all you ate you would die in short order. The same is true of vitamins. Nutrients are not drugs and they can’t be studied as drugs. They are part of a biological system where all nutrients work as a team to support your biochemical processes.
Michael Jordon may have been the best basketball player in history, but he couldn’t have won six NBA titles without a team.
Obesity is Linked to Malnutrition
The tragedy of media attention on poor studies like these is that they undermine possible solutions to some of the modern health epidemics we are facing today, and they point attention away from the real drivers of disease.
Take the case of obesity for example. Paradoxically Americans are becoming both more obese and more nutrient deficient at the same time. Obese children eating processed foods are nutrient depleted and increasingly get scurvy and rickets, diseases we thought were left behind in the 19th and 20th centuries.
After treating over 15,000 patients and performing extensive nutritional testing on them, it is clear Americans suffer from widespread nutrient deficiencies including vitamin D, zinc, magnesium, folate, and omega 3 fats. This is supported by the government’s National Health and Nutrition Examination Survey (NHANES) data on our population. In fact 13% of our population is vitamin C deficient.
Scurvy in Americans in 2011? Really? But if all you eat is processed food – and many Americans do— then you will be like the British sailors of the 17th century and get scurvy.
Unfortunately negative studies on vitamins get huge media attention, while the fact that over 100,000 Americans die and 2.2 million suffer serious adverse reactions from medication use in hospitals when used as prescribed is quietly ignored. Did you know that anti-inflammatories like aspirin and ibuprofen kill more people every year than AIDS or asthma or leukemia?
Flaws with the “Vitamins Kill You” Study
So what’s the bottom line on this study on vitamins in older white women in Iowa?
After a careful reading of this new study a number of major flaws were identified.
1. Hormone replacement was not taken into consideration. Overall the women who took vitamins were a little healthier and probably more proactive about their health, which led them to use hormone replacement more often (based on recommendations in place when this study was done). 13.5% of vitamin users also used hormones, while 7.2% of non-vitamin users took hormones. Remember the Women’s Health Initiative Study I mentioned above? It was a randomized controlled trial that found hormone therapy dramatically increases risk of heart attack, stroke, breast cancer, and death. In this Iowa women’s study on vitamins, the degree of the effect of harm noted from the vitamins was mostly insignificant for all vitamins except iron (see below) and calcium (which showed benefit contradicting many other studies). In fact, the rates of death in this study were lower than predicted for women using hormone therapy, so in fact the vitamins may have been protective but the benefit of vitamins was drowned out because of the harmful effects of hormones in the vitamin users.
2. Iron should not be given to older women. Older women should never take iron unless they have anemia. Iron is a known oxidant and excess iron causes oxidative stress and can lead to cardiovascular disease and more. This is no surprise, and should not make you stop taking a multivitamin. If you are an older woman, you simply need to look for one without iron. Most women’s vitamins do not contain it anyway.
3. Patient background was ignored. In this observational study it was not known why people started supplements. Perhaps it was because of a decline in their health and thus they may have had a higher risk of death or disease that wasn’t associated with the vitamins they were taking at all. If you had a heart attack or cancer and then started taking vitamins, of course you are more likely to die than people without heart attacks or cancer.
4. The population was not representative. The study looked only at older white women – clearly not representative of the whole population. This makes it impossible to generalize the conclusions. Especially if you are an obese young African American male eating the average American diet.
5. Forms and quality of vitamins were not identified. There was no accounting for the quality or forms or dosages of the vitamins used. Taking vitamins that have biologically inactive or potentially toxic forms of nutrients may limit any benefit observed. For example synthetic folic acid can cause cancer, while natural folate is protective.
6. A realistic comparison between vitamins and other medications as cause of death was not made. 0ver 100,000 people die every year from properly prescribed medication in hospitals. These are not mistakes, but drugs taken as recommended. And that doesn’t include out of hospital deaths. The CDC recently released a report that showed in 2009, the annual number of deaths (37,485) caused by improper/overprescribing and poor to non-existent monitoring of the use of tranquilizers, painkillers and stimulant drugs by American physicians now exceeds both the number of deaths from motor vehicle accidents (36,284) and firearms (31,228).
In short, this recent study confuses not clarifies, and it has only served up a dose of media frenzy and superficial analysis. It has left the consumer afraid, dazed, bewildered and reaching for their next prescription drug.
Please, be smart, don’t stop taking your vitamins. Every American needs a good quality multivitamin, vitamin D and omega-3 fat supplement. It is part of getting a metabolic tune up and keeping your telomeres long!
For more information on getting a metabolic tune up see www.drhyman.com.
Now I’d like to hear from you …
What do you think about the recent media hype regarding vitamins?
Why do you think vitamins get this kind of media while pharmaceuticals, which have a much larger impact, are often ignored?
Why do you think the decades of research showing positive effects of vitamins is hidden?
To your good health.
August 22nd, 2011
The Huffington Post
By: Linda A. Johnson
The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer.
In June, Takeda Pharmaceuticals Co. Ltd. halted sales of Actos, its top drug, in Germany and France after pressure from regulators.
Since then, both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research, but they have allowed sales to continue. Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.
The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that debuted more than a decade ago amid heavy promotion.
The once-a-day pills were appealing. They helped control blood sugar tightly, had few side effects in most patients, boosted the effects of some other diabetes drugs, worked by a new mechanism – improving the body’s sensitivity to insulin – and even allowed patients to reduce or delay use of injected insulin.
Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.
Now those billions may well shift to Takeda rivals.
In the past week, the first of what lawyers predict will be thousands of lawsuits were filed in courts across the country. They allege Actos triggered bladder cancer, in some cases fatal, in clients who took the pills daily for years.
Nancy Rios, 54, is suing Takeda, blaming her recurrent bladder cancer on Actos, which she took for more than a decade. Rios, a hospital secretary, was diagnosed with bladder cancer in 2009. In June, she had her second surgery to remove tumors. Rios, who lives in Reading, Pa., is worried about missing more work and being able to pay her medical bills. Next month, she will learn whether more treatment is needed.
“I could lose my bladder and possibly need chemo,” she said.
Her attorney, Paul Pennock of Weitz & Luxenberg, said the firm already represents another 104 clients, has about 120 more expected to pursue lawsuits and is getting 30 to 40 possible new cases a week.
“When a manufacturer distributes a drug, they owe it to the public to ensure that their product is safe for use and it appears that Takeda Pharmaceuticals failed to fulfill that fundamental duty,” Pennock said.
Other large law firms are evaluating potential cases by the dozen or more. More than 20 firms, from Florida to Washington state, are advertising for clients on the Internet or in newspapers, a standard practice in personal injury law.
“We don’t think it’s a coincidence that we’ve been contacted by so many people who have been taking Actos and have bladder cancer,” said Marc Jay Bern of Napoli Bern Ripka Shkolnik & Associates. “We have more than 100 (cases) that we’ve confirmed and many more that we’re evaluating.”
Takeda declined to comment on the lawsuits. The company, which is based in Japan, has issued statements that it’s committed to keeping Actos available for patients who need it.
Spokeswoman Elissa Johnsen noted an April study in the journal Diabetes Care found Actos “use for more than two years was weakly associated with increased risk.”
However, the FDA analyzed data from the first five years of a 10-year Actos safety study Takeda begun in 2002 and concluded this June that risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year, although still small: an extra 28 cases a year for every 100,000 people taking it.
Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business, said Friday that the new safety questions are “a big deal” for Takeda, particularly since the Actos patent expires in August 2012. They mean Actos won’t make as much money as expected in the final months, and they dampen prospects for two experimental drugs Takeda was hoping would succeed Actos.
“One, alogliptin, has been stuck at the FDA over safety concerns, and the other, a combination of alogliptin and Actos, now looks doomed,” Gordon said.
Alogliptin is an experimental drug in the same class as Merck & Co.’s blockbuster Januvia. Those drugs increase production of insulin, which breaks down sugar in the blood, and reduce glucose production in the liver.
Les Funtleyder, an analyst and portfolio manager for the Miller Tabak Health Care Transformation fund, said Januvia is likely to gain sales as patients defect from Actos.
He doubts the cost of the bladder cancer litigation will hit the level of Vioxx. That’s the painkiller that Merck pulled off the market in 2004 because it doubled risk of heart attacks and strokes – triggering more than 50,000 lawsuits and, eventually, a $4.85 billion settlement to end most of them.
Whatever the outcome of the Actos litigation, diabetes patients and their doctors will be considering their options now.
Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said more long-term data on the effects of Actos is needed.
“It’s not clear if this (bladder cancer) risk is real,” but Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures, he said. “The consensus already is that (Actos) should only be considered … after patients have exhausted all other options.”
Today, Kevin risks his own freedom to give YOU the truth! Find out why the FTC is going after him and not McDonald’s or Big Pharma and why the first amendment apparently doesn’t apply to him.
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February 14th, 2011
By: David Gutierrez
A single glass of red wine may be as effective at controlling blood sugar as standard diabetes drugs, according to a study conducted by researchers from the University of Natural Resources and Applied Life Sciences in Vienna, Austria.
Previous research has shown that red wine, grape skins and red grape juice are high in plant chemicals called polyphenols. These antioxidants have been shown to help the body regulate blood sugar, and may thereby help prevent or control diabetes. In the current study, researchers studied the action of grape polyphenols on a cell receptor called PPAR-gamma, which plays an important role in blood sugar regulation, energy storage and fat storage. They found that even a small glass of wine has enough polyphenols to activate the receptor at least as effectively as the diabetes drug Avandia.
The researchers also compared the polyphenol content of 12 different wines, confirming the popular wisdom that concentrations are higher in red wine.
“This is further scientific evidence that a small amount of wine really is beneficial for health,” researcher Alois Jungbauer said.
He cautioned, however, that wine can be high in calories and that moderate consumption is key.
“Moderate is the equivalent of a small glass each day for women, and two for men,” he said. “Our big problem is to convey the message of a healthy lifestyle because too much wine will cause diabetes and obesity.”
“If you have wine then you must reduce your intake of calories from food by the same amount.”
Moderate wine consumption is a characteristic of the Mediterranean Diet, which has been shown to improve lifespan and reduce the risk of chronic disease.
“The traditional Mediterranean diet has shown tremendous benefit in fighting heart disease and cancer, as well as diabetes,” write Michael Murray and Joseph Pizzorno in The Encyclopedia of Healing Foods.
“It has the following characteristics: Olive oil is the principal source of fat. The diet centers on an abundance of plant food, including fruit, vegetables, breads, pasta, potatoes, beans, nuts, and seeds. Foods are minimally processed, and there is a focus on seasonally fresh and locally grown foods.”
December 27th, 2010
By: David Gutierrez
The FDA has begun investigations into whether the widely used diabetes drug pioglitazone (marketed as Actos) may increase the risk of bladder cancer.
Actos is already known to carry a risk of “serious side effects on the liver,” writes Phyllis A. Balch in the book Prescription for Nutritional Healing, 4th Edition. Nevertheless, the drug has remained one of the top-prescribed diabetes drugs because although it also increases patients’ risks of heart failure, it is only half as likely to produce heart attacks as its primary competitor Avandia (rosiglitazone).
Following years of controversy, the FDA recently prohibited the prescription of Avandia except as a last resort in cases where all other diabetes drugs and treatments have failed.
According to a five-year study by Actos manufacturer Takeda Pharmaceuticals, patients taking the drug had a non-statistically significant, 20 percent higher risk of bladder cancer diagnosis. The risk was higher among patients who had been taking the drug for more than two years, and was highest among those who had been exposed to the highest levels.
Although the results of this study did not reach statistical significance, they were enough to spur the FDA to investigate further. Two prior clinical trials and a laboratory study in rats have also pointed to a link between the drug and bladder cancer.
Rates of Type 2 diabetes continue to rise worldwide with worsening diet and an ensuing higher prevalence of obesity. Studies have linked higher consumption of red and processed meats, eggs and fruit juice with a higher risk of the disease. Higher intake of coffee, fish, garlic, brown rice, turmeric, omega-3s and certain micronutrients have been linked with a lower risk.
In addition to eating a balanced diet, more exercise and more time in the sun (leading to higher vitamin D levels) are among the most reliable ways to reduce diabetes risk.
December 16th, 2010
By: David Gutierrez
Omega-3 fatty acids are “incredibly potent” anti-inflammatories, which may explain why they have been linked with lowered rates of diabetes and heart disease, according to a study conducted by researchers from the University of California-San Diego and published in the journal Cell.
In an experiment conducted on mice, the researchers examined how omega-3s interact with specialized white blood cells known as macrophages, which digest harmful molecules and cellular debris. As part of their operation, macrophages naturally secrete chemicals that produce an inflammatory response.
The researchers found that macrophages contain an omega-3 receptor, GPR120, that causes them to stop producing these inflammatory chemicals.
In a second experiment, the researchers genetically modified a group mice to lack a GPR120 receptor, then fed a high-fat diet to both modified and normal mice. All the mice became obese and developed diabetes. When their diets were then supplemented with omega-3s, only the non-modified mice exhibited improvement in their symptoms. In these mice, omega-3 supplementation was as effective at restoring insulin sensitivity as the drug Avandia.
“It’s just an incredibly potent effect,” researcher Jerrold Olefsky said. “The omega-3 fatty acids switch on the receptor, killing the inflammatory response.
“This is nature at work. The receptor evolved to respond to a natural product — omega-3 fatty acids — so that the inflammatory process can be controlled. Our work shows how fish oils safely do this, and suggests a possible way to treating the serious problems of inflammation in obesity and in conditions like diabetes, cancer and cardiovascular disease through simple dietary supplementation.”
Omega-3 fatty acids naturally occur in fish oil and in some vegetable foods such as canola oil, flax seeds, chia, kiwifruit, and purslane. Many researchers now believe that the average Western diet contains a lower content of these oils than is necessary for optimal health.
November 18th, 2010
By: Henry Samuel
France’s second-largest pharmaceutical group was yesterday at the heart of a spiralling health scandal over Mediator, a drug initially reserved for obese people with diabetes that became a popular appetite suppressor.
Afssaps, the drug safety body, yesterday said expert epidemiologists believed Mediator, made by Servier, had been lethal for at least 500 people and had caused 3,500 others to be admitted to hospital since its launch in 1976.
Some 300,000 people were taking the drug when Afssaps pulled it from the market last November, saying it had little effect on diabetes and might lead to a dangerous thickening of heart valves. The European Medicines Agency followed suit.
But the ban was applied too slowly in France, it was claimed yesterday, given repeated warnings of its potentially lethal side effects. Dr Irène Frachon, who wrote a book on Mediator’s dangers and warned Afssaps in February last year, said: “The health authorities were late in withdrawing this drug despite several alerts.”
The drug was pulled from Italy and Spain in 2005, according to Servier, because it was not commercially successful enough. “Why didn’t they do it earlier [in France]?” asked Dr Frachon, whose book charts her difficulties in getting officials to admit the drug was dangerous. The result, she added, had been a “health disaster”.
Xavier Bertrand, France’s new health minister, advised anyone who had taken the drug – but above all those who took in the past four years – to see a doctor. “We will ask the health service to contact all patients concerned,” said Mr Bertrand just hours after taking up his new post after a reshuffle. Hundreds of thousands could now be seeking appointments with their doctor.
The Servier group dismissed the death count estimate as “theories founded on extrapolation”. A spokesman told The Daily Telegraph: “Simply observing a valve problem in a diabetic person does not allow it to be attributed to medicinal treatment which remains a very rare cause.”
Even accepting the official figures, the risk of death is only 0.005 per cent, the company added. “You have to weigh the benefits against risks in all drugs. If you made similar studies on others still on the market, probably even aspirin, you’d come up with similar results.”
In total, Servier sold 145 million boxes of Mediator in France to almost three million people. Last year, it accounted for 30 million euros (£25 million) – less than 1 per cent of the group’s 3.6 billion-euro turnover.
Gérard Bapt, a cardiologist and head of a parliamentary health commission for the opposition Socialist party, suggested elements of the health authorities were under the influence of France’s pharmaceutical lobby. Mr Bapt pointed out that Mediator was almost identical to another Servier drug, Isoméride, banned in 1997. “I get the feeling some experts working for Afssaps are very close to this laboratory,” he told Le Parisien.
Isoméride’s American equivalent, Redux, was banned in the US in 1997, leading to a $12 billion-settlement (£7.6 billion) following class action by tens of thousands of patients.
Yesterday’s health statement was expected to spark a rash of legal action against Servier, already facing four lawsuits over Moderator and ordered to pay 210,000 euros to an Isoméride patient last year.
In September, European regulators pulled GlaxoSmithKline’s blockbuster diabetes pill, Avandia, off the market and the US Food and Drug Administration placed major restrictions on the drug following research suggesting links to heart attacks.
French governments have been extremely wary of health scandals since HIV-tainted blood was given to hundreds of haemophiliacs in the mid-1980s. A group of top doctors are currently on trial for indirectly causing the deaths of 117 children by injecting them with growth hormones tainted with the human form of mad cow disease.