NEJM editor: “No longer possible to believe much of clinical research published”

NEJM editor: “No longer possible to believe much of clinical research published”

Harvard Medical School’s Dr. Marcia Angell is the author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It. But more to the point, she’s also the former Editor-in-Chief at the New England Journal of Medicine, arguably one of the most respected medical journals on earth. But after reading her article in the New York Review of Books called Drug Companies & Doctors: A Story of Corruption, one wonders if any medical journal on earth is worth anybody’s respect anymore.

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

Dr. Angell cites the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard’s Massachusetts General Hospital. She explains:

“Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose, and none of which were approved for children below ten years of age.”

Biederman’s own studies of the drugs he advocates to treat childhood bipolar disorder were, as The New York Times summarized the opinions of its expert sources, “so small and loosely designed that they were largely inconclusive.”

In June 2009, an American senate investigation revealed that drug companies, including those that make drugs he advocates for childhood bipolar disorder, had paid Biederman $1.6 million in “consulting” and “speaking” fees between 2000 and 2007.

“Two of Biederman’s colleagues received similar amounts. After the revelation, the president of the Massachusetts General Hospital and the chairman of its physician organization sent a letter to the hospital’s physicians expressing not shock over the enormity of the conflicts of interest, but sympathy for the beneficiaries: “We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them.”

Biederman’s failure to disclose his Big Pharma payments to his employers ar Harvard (as is required for all Harvard employees) has been under investigation* for the past two years by Harvard Medical School, in as journalist Alison Bass describes this: “what must be the longest investigation in that school’s history”).

Dr. Angell’s article contains bombshell after bombshell, all gleaned during her tenure as NEJM editor. For example, on the subject of doctors who are bought and paid for by Big Pharma, she writes:

“No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top 9 U.S.-based drug companies that it comes to tens of billions of dollars a year in North America alone.By such means, the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease.”

Revelations like this from medical profession insiders cast serious doubt on more than what’s printed on the pages of these medical journals.

Your physician reads these journals, treatment decisions are changed, care is affected, drugs are prescribed – all based on Big Pharma-funded medical ghostwriter-prepared journal articles from physicians who fraudulently claim to be the study authors. Then you walk out of your doctor’s office with a prescription for a drug that may or may not kill you, based on treatment protocols written by doctors like Biederman who are on the take from Big Pharma.

A very recent example of the sad reality over at the once-prestigious New England Journal of Medicine is their decision to publish a drug company-funded review article. This review attempts to discredit emerging research suggesting that many years of using Merck’s Fosamax or Procter & Gamble’s Actonel (both osteoporosis drugs in a class called bisphosphonates) could actually result in more leg bone fractures.

Not surprisingly, drug manufacturers of bisphosphonates are fighting back ferociously against this emerging (independent) research. A Merck-funded review paper published in the NEJM on March 24, 2010 concludes:

“The occurrence of fracture of the subtrochantericor diaphyseal femur was very rare, even among women who had been treated with bisphosphonates for as long as 10 years.”

Sounds promising for Big Pharma. But if you look very, very closely, the article’s fine print confesses:

“The study was underpowered for definitive conclusions.”

You might justifiably ask yourself why a medical journal would stoop to publishing a meaningless scientific paper that the paper’s own authors admit lacks any conclusion. Even more troubling than a journal article that was itself bought and paid for by Merck, is the conflict of interest disclosure list at the bottom of this NEJM article. It reads like a Who’s Who of Big Pharma.

Of the 12 study authors listed in the NEJM article, at least three are full-time employees of Merck or Novartis. Each one of the other nine admit owning equity interests in or receiving cash, travel expenses, or “consulting and lecture fees” from companies including Merck, Novartis, Amgen, Roche Nycomed, Procter & Gamble, AstraZeneca, GlaxoSmithKline, Medtronics, Nastech, Nestle, Fonterra Brands, OnoPharma, Osteologix, Pfizer, Eli Lilly, Sanofi-Aventis, Tethys, Unilever,Unipath, Inverness Medical, Ortho Clinical Diagnostics, OSIProsidion, or Takeda.
Why is the New England Journal of Medicine or any other credible medical journal accepting for publication articles submitted by paid employees of pharmaceutical companies?

As a cardiac patient, I’m gobsmacked by what appears to be this systemic corruption of not only medical journals who continue to publish what they clearly know is tainted research linked to drug marketing, but of the very doctors whom patients trust to look out for us. Since my heart attack in 2008, I take a fistful of cardiac meds every day, and I have no clue which of them were prescribed for me based on flawed research or tainted medical journal articles funded by the very companies that make my drugs.

And worse, neither do my doctors.

Happily, there are other decent physicians out there who, like Dr. Angell, are just as outraged as she is. Her targets are not just guilty of unethical conflict of interest – they are criminals who should be charged with endangering our health while padding their wallets.

Read Dr. Angell’s article from the New York Review of Books, called Drug Companies & Doctors: A Story of Corruption.

* NEWS UPDATE: “Massachusetts General Hospital Discloses Sanctions against Three Psychiatrists for Violating Ethics Guidelines”, July 1, 2011: The Boston Business Journal said today that three psychiatrists have been sanctioned for failing to adequately report seven-figure payments they received from drug companies.

Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens disclosed the disciplinary actions against them in a note to colleagues. According to a copy of the note made public upon request by the hospital, the three doctors:

• must refrain from “all industry-sponsored outside activities” for one year

• for two years after the ban ends, must obtain permission from Mass. General and Harvard Medical School before engaging in any industry-sponsored, paid outside activities and then must report back afterward

• must undergo certain training

• face delays before being considered for “promotion or advancement.”

The three doctors have been under the political microscope since June 2008 when Senator Charles Grassley, R-Iowa, began investigating conflicts of interest involving clinicians. Biederman and Wilens have since admitted to accepting $1.6 million from drug companies whose drugs they were promoting; Spencer took $1 million.

Senator Grassley said, according to an online version of the Congressional record:

“These three Harvard doctors are some of the top psychiatrists in the country, and their research is some of the most important in the field. They have also taken millions of dollars from the drug companies.”

See also:

• Does The Medical Profession Need To Wean Itself From The Pervasive Dependence on Big Pharma Money?
• Warning: Clinical Trials Funded by Drug Companies May Appear More Truthful Than They Actually Are
• Harvard Cozies Up with Big Pharma
• Harvard’s Ethical Ultimatum to Doc: Give Up Big Pharma Moonlighting Jobs, or Lose Harvard Teaching Post
• Is Your Doctor a “Thought Leader”?
• Bad Doctors Earning Good Money from Big Pharma
• Doctor’s Kiss & Tell Tale: My One-Year Career As a Drug Rep

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Read the complete article here.

Why Asians Should Ignore the Cholesterol Sham, and Why Healthy People Should Not Take Statins- Colpo

Why Asians Should Ignore the Cholesterol Sham, and Why Healthy People Should Not Take Statins

Anthony Colpo  Saturday, April 28th, 2012

Folks, before I get rolling, I would just like to dedicate this first instalment of many more cholesterol updates to come to my good buddies Pee Pee and Don Matesz and all those other dopey buggers who make a pastime of accusing me of being a cherry-picker. Today, I’m going to share with you studies you’ve probably never heard of, because they just happen to flatly contradict the mainstream assertion that low cholesterol is healthy and hence are quietly shoved aside by purveyors of this belief due to their embarrassing nature. As we know, one of the favourite strategies humans have for dealing with evidence that contradicts their cherished dogmas is to simply ignore it.

In the twisted worldview of Don, Pee Pee and their ilk, by presenting the studies that you likely never would have heard of due to their embarrassing nature, it is people like me – not them – that are cherry-picking.

Yeah, no worries.

Come and Get ‘Em!
Folks, who wants some cherries? I’ve got a basket full here, and you’re all welcome to grab a handful. They might not be highly-hyped, front page, AHA- or Big Pharma-press-release cherries, but they are definitely sweet, tasty, and certified peer-reviewed delicacies. Enjoy!

Low Cholesterol is Accompanied by Increased Mortality from Stroke, Heart Disease, and Cancer: The Jichi Study
The Asians we are told, are shining examples of the cholesterol theory. They eat a low-fat diet, which gives them wonderfully low cholesterol levels, which in turn not only protects them from heart disease but endows them with the longest average life expectancy on Earth.
Sounds great, doesn’t it?

Too bad it’s complete nonsense.

Being the cherry-picker I am, I discussed the evidence, so often ignored by others, in The Great Cholesterol Con that low cholesterol is strongly associated with increased mortality in Japan.
Yeah, shame on me for pointing out to our Japanese brethren that this whole cholesterol-lowering thing is just another overhyped Western wank, one with the potential to harm instead of hurt their health.

Funnily enough, I don’t feel any shame at all. Au contraire, I believe reporting the facts is a noble thing to do, even if it upsets every last dogmatic sod who can’t get his head around the fact he has fallen hook, line and sinker for a load of unscientific rot.

Which is why, dear readers, I bring you the results from The Jichi Medical School Cohort Study, which involved 12,334 healthy Japanese adults aged 40 to 69 years who underwent a mass screening examination (1992-2005), including total cholesterol measurement. Information regarding cause of death was obtained from death certificates, and the average follow-up period was 11.9 years. In total, 635 men and 423 women died during the study period.

The subjects were divided into 4 groups according to total cholesterol level (<4.14mmol/L; 4.14mmol/L to <5.17 mmol/L; 5.17 mmol/L to <6.20 mmol/L, and; >6.21 mmol/L).
Before I report the results, it should be pointed out that the lowest quartile of cholesterol (<4.14mmol/L) , in both male and female participants, was marked by a higher number of current cigarette smokers.

So did multivariate analyses, which many misguided Western researchers seem to think grants epidemiology the same accuracy as RCT data, and which in this instance included adjustment for smoking, age, systolic blood pressure, HDL, drinking, and body mass index confirm the wonderful life-saving benefits of having low cholesterol?

Nope.

The safest cholesterol range in the study was 4.14–6.20 mmol/L in men, and 4.14mmol/L – >6.21 mmol/L in women. As the researchers stated:

“We noted a clear relationship between low cholesterol and increased mortality. Okamura et al reported that occult liver diseases are associated with mortality; however, in the present study, the relationship between low cholesterol and increased mortality was unchanged in analyses that excluded deaths due to liver disease. Our results suggest that hemorrhagic stroke and heart failure excluding myocardial infarction,contribute to the relationship between low cholesterol and high mortality.”

You can check out the full text of the study here:

Nago N, et al. Low Cholesterol is Associated With Mortality From Stroke, Heart Disease, and Cancer: The Jichi Medical School Cohort Study. Journal of Epidemiology, 2011; 21 (1): 67-74.
Yeah, I know, shame on me for allowing you to view the paper yourself…I need to do what folks like Don and Pee Pee do and make sweeping claims and libelous accusations, then refuse to back them up with even a single paper!

Must be the cherry-picker in me…

Low Cholesterol is Associated with Increased Mortality from CVD in Korean adults.
Maybe the Koreans can save the cholesterol cartel’s Asian thesis, no?
No.

A total of 12,740 Korean adults aged 40 to 69 who underwent a mass screening examination were followed up from 1993 to 2008. Groups with the lowest cholesterol (< 160 mg/dL) as well as the highest (>= 240 mg/dL) were associated with higher CVD mortality in analysis adjusting for age, sex, smoking and drinking status, body mass index, level of blood pressure, triglyceride and HDL.

The researchers noted:

“Based on the results of this study, caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk in Korean adults.”

Aw c’mon guys, the nice folks from Big Pharma won’t like that, will they? Don’t you know that the Asian market, especially China, represents a huge and largely untapped reservoir of profit, but by showing the kind of independent and critical thinking sadly lacking in most of your Western colleagues you’re ruining the party?

Tsk tsk.

Again, dear readers, if you’d like to read the paper yourself, feel free to do so here:

Bae JM, et al. Low cholesterol is associated with mortality from cardiovascular diseases: a dynamic cohort study in Korean adults. J Korean Med Sci. 2012 Jan; 27 (1): 58-63.

Statins are Largely a Waste of Time
As for statins, they’re not just a wank for Asians, they’re a load of cobblers for Westerners too.
The Journal of the American Medical Association recently published a “for” and “against” installment posing the following hypothetical question:

“Should a 55-year-old man who is otherwise well, with systolic blood pressure of 110 mm Hg, total cholesterol of 250 mg/dL, and no family history of premature CHD be treated with a statin?”

To answer this question, JAMA enlisted Blaha, Nasir and Blumenthal from The Johns Hopkins Ciccarone Center for the Prevention of Heart Disease for the “yes” case, and Redberg and Katz from the Division of Cardiology, Department of Medicine, University of California, San Francisco (Dr Redberg) and Department of Health Services, County of Los Angeles (Dr Katz) for the “no” case (Drs Redberg and Katz are also Editor and Deputy Editor, respectively, over at the Archives of Internal Medicine).

To support their “yes” case, the Hopkins crew begin by citing a bunch of cholesterol guidelines that were formulated by panel members sponsored by manufacturers of statins. Yep, I’m sure we can rely on those for accurate, unbiased guidance when tooling around with someone’s health!

They then cite the WOSCOPS and AFCAPS/TexCAPS trials and report the former lowered heart attack and CHD mortality by 31%, while the latter reduced heart attacks by 40%.
Um, fellas … isn’t there something you’re forgetting to tell us about those studies?

Like the fact that the 27% reduction in CHD mortality in AFCAPS/TexCAPS did not reach statistical significance? And that there was no reduction whatsoever in overall mortality?

And the fact that the 27% reduction in CHD mortality in WOSCOPS also did not reach statistical significance?

Instead of reporting these facts about actual death rates, the researchers only reported (read: cherry-picked) outcomes that managed to reach statistical significance and ignored those that didn’t.
Recommending a toxic drug to healthy individuals free of CHD using such dubious interpretation of these largely unsuccessful studies is, to my way of thinking, BoLLOCKS.

The Hopkins team then trot out the absolute farce that was JUPITER, this time including a total mortality reduction of 20% reported in that trial. For me to outline all the discrepancies in this trial – that was conveniently cut short as the mortality trajectories of the treatment and control groups began to menacingly converge – would be a whole other article. Luckily, someone else has already saved me the time and posted a pearler of a critique right here:

http://junkfoodscience.blogspot.com.au/2008/11/when-news-sounds-too-good-statins-new.html

After reading that, I’m sure most everyone apart from Pee Pee, Matesz and the JUPITER researchers themselves will agree that citing JUPITER in support of anything other than the all-too-frequent shadiness of Big Pharma-sponsored research is POPPYCoCK and HogWASH.

The Hopkins team then go onto cite some more theoretical figures, then argue that statins are safe, claiming only 5% of patients experience muscle pains.

Incorrect. The reality is that such complaints are dramatically underreported, thanks to doctors’ refusal to believe the ‘wonder drug’ statin they prescribed could ever do anything negative to their patient. And in those who do acknowledge the cause of the muscle pain, filing an official complaint is a time-consuming affair for which they receive no compensation and may even be subject to interrogation about the circumstances that led to the filing of the report.

But what happens when, instead of brushing people off and telling them their symptoms are just due to “getting old”, researchers carefully inspect patient data and make further enquiries? A study published in the October-November-December 2009 issue of Primary Care Cardiovascular Journal, indicates that statin-induced myopathy is far more common than previously claimed by drug companies and health officials. Researchers analyzed the patient records of one 8,000 patient practice and found only one recorded case of muscle symptoms in a patient taking statins. But after questioning 96 randomly selected statin-using patients from the practice, they identified 19 cases of potential muscle damage:

Sciberras D, et al. Is general practice the optimal setting for the recognition of statin-induced myotoxicity? Primary Care cardiovascular Journal, Oct-Nov-Dec, 2009; 2: 195-200.

As for the question of whether statins should be prescribed to women, Blaha et al cite a review by Kostis et al that claims statins also work in women – but ignore two other reviews that concluded statins do not:

1. Walsh JM, Pignone M. Drug Treatment of Hyperlipidemia in Women. JAMA. 2004; 291 (18): 2243-2252.
2. Petretta M, et al. Impact of gender in primary prevention of coronary heart disease with statin therapy: A meta-analysis. International Journal of Cardiology, 2010; 138 (1): 25-31.

So what do Redberg and Katz, who argue the “No” case, have to say in response to the selectively cited arguments of Blaha and co?

Instead of citing a small handful of incompletely reported trials, they report that:

“Data from a meta-analysis of 11 trials including 65 229 persons with 244 000 person years of follow-up in healthy but high-risk men and women showed no reduction in mortality associated with treatment with statins. A 2011 Cochrane review of treatment with statins among persons without documented coronary disease came to similar conclusions. The Cochrane review also observed that all but one of the clinical trials providing evidence on this issue were sponsored by the pharmaceutical industry. It is well established that industry-sponsored trials are more likely than non–industry-sponsored trials to report favorable results for drug treatment because of biased reporting, biased interpretation, or both of trial results.”

As for the commonly claimed low rate of side effects in statin users, they note:

“This underestimation of adverse events occurs because the trials excluded up to 30% of patients with many common comorbidities, such as those with a history of muscular pains, as well as renal or hepatic insufficiency. Many randomized trials also excluded patients who had adverse effects of treatment during an open label run-in period. For example, in the Treat to New Targets trial, after initial exclusions based on comorbidities, an additional 35% of eligible patients, or 16% of patients, were excluded during an 8-week, open-label, run-in phase because of adverse events, ischemic events, or participants’ lipid levels while taking the drug not meeting entry criteria. Additionally, the results of randomized trials of statin treatment likely underestimate common symptoms such as myalgia, fatigue, and other minor muscle complaints because these studies often only collect data on more quantifiable adverse effects such as rhabdomyolysis.

Numerous anecdotal reports as well as a small trial have suggested that statin therapy causes cognitive impairment, but this adverse outcome would not have been captured in randomized trials. The true extent of cognitive impairment associated with statins remains understudied. It is disappointing that more data are not available on important adverse events associated with statin treatment, despite millions of prescriptions and many years of use. This information could be easily collected in observational studies and from registries. One population-based cohort study in Great Britain of more than 2 million statin users found that statin use was associated with increased risks of moderate or serious liver dysfunction, acute renal failure, moderate or serious myopathy, and cataract. The risk of diabetes with statin use has been seen in randomized clinical trials such as JUPITER, which found a 3% risk of developing diabetes in the rosuvastatin group, significantly higher than in the placebo group. In observational data from the Women’s Health Initiative, there was an unadjusted 71% increased risk and 48% adjusted increased risk of diabetes in healthy women taking statins.”

Their conclusion?

“Based on all current evidence, a healthy man with elevated cholesterol will not live any longer if he takes statins. For every 100 patients with elevated cholesterol levels who take statins for 5 years, a myocardial infarction will be prevented in 1 or 2 patients. Preventing a heart attack is a meaningful outcome. However, by taking statins, 1 or more patients will develop diabetes and 20% or more will experience disabling symptoms, including muscle weakness, fatigue, and memory loss.”

Statins. They still suck.
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Read the complete article here.

Busted! Scientists leave out data to produce bogus findings

Clinical trials of drugs and other medical therapies are carefully carried out and are the very gold standard of scientific proof, right? According to an in-depth review of this question just published in the British Medical Journal (BMJ,) the answer is no. In fact, the BMJ is sounding the alarm that data reported by scientists is too often not the truth -- because the researchers leave out inconvenient evidence. The result of facts-gone-missing could well be harming patients, spiking up healthcare costs by the selling of medical treatments based on bogus findings, and threatening the very integrity of medicine.

These warnings come from multiple papers released by the BMJ. The whistle-blowing authors of these articles examined the extent, causes, consequences of hidden facts, figures, and other data scientists discover as they do human trials. It turns out this is no "once in a while" kind of problem, either. The BMJ claims a "large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately."

In an editorial, Dr. Richard Lehman from the University of Oxford and BMJ Clinical Epidemiology Editor, Dr. Elizabeth Loder, nail the current state of medical research as a "culture of haphazard publication and incomplete data disclosure." They call for full access to raw trial data to allow better understanding of the benefits and harms of many treatments.

Bottom line: when data is left out, the missing facts distort the scientific record and published results of a study. This then leads doctors to make potentially dangerous clinical decisions about what drugs or procedures patients need because the docs are relying on skewed and even bogus "evidence."

Conveniently missing facts left out of drug trials and more

Papers in the current issue of BMJ include a study by Dr. Beth Hart and colleagues, which document how unpublished data is "conveniently missing" from many published meta-analyses of drug trials. That's right. Big Pharma's pills and potions are often pushed based on studies that simply ignore and leave out major data about what was really discovered about a medication lacking of benefits, potential dangers, side effects and more. Dr. Hart's team argues that access to full trial data is necessary to allow drugs to be independently assessed.

Two additional studies show the requirements for mandatory trial registration and timely sharing of results are poorly followed, if at all. For example, it turns out that less than half of US National Institutes of Health funded trials are published in a peer reviewed journal within 30 months of completion and only 22 percent of trials that are supposed to be subject to mandatory reporting had results available within one year of completion.

"When the word mandatory turns out to mandate so little, the need for stronger mechanisms of enforcement becomes very clear," the researchers report.

And what happens when ethical, dedicated scientists try to assess true harms vs benefits of Big Pharma drugs and other interventions? It's not a pretty picture for their careers, apparently. Additional studies published in the special BMJ issue highlight the many difficulties these researchers face when they try to buck the system.

Dr. Lehman and Dr. Loder, however, are bravely speaking out and directly saying that a concealment of data in clinical trials is anything but unusual. They label this "a serious ethical breach" and demand that clinical researchers who fail to disclose data "should be subject to disciplinary action by professional organizations. These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavor of clinical medicine."

For more information:

http://www.bmj.com/

http://www.naturalnews.com/medical_errors.html

Learn more: http://www.naturalnews.com/034577_quack_science_clinical_trials_BMJ.html#ixzz1iaunAKmd

Bad News For Statins Is Good News

Bad News For Statins Is Good News


Posted by Tom Naughton in Bad Medicine
Let’s hope this is the beginning of the end for statins. The so-called wonder drugs have been a cash cow for pharmaceutical companies for decades now, mostly because doctors bought into the idea that high cholesterol causes heart disease, therefore any drug that reduces cholesterol must also reduce heart disease. I’ve lost count of the people I know who don’t have atherosclerosis, but were prescribed statins simply because their cholesterol was above the supposedly magic number of 200. Their doctors weren’t treating heart disease; they were treating a cholesterol score.
While researching Fat Head, I became aware of quite a few doctors who insist that giving statins to people who don’t already have heart disease simply to beat down their cholesterol is worse than worthless … Al Sears, Mike and Mary Dan Eades, Uffe Ravnskov, Malcolm Kendrick, etc. I found the evidence they presented quite convincing. Unfortunately, the medical establishment and the media have tended to either ignore the anti-statin doctors or write them off as a bunch of kooks.
Not anymore … at least I hope not. A new meta-analysis of the effectiveness of statins (and lack thereof) was just released by the Cochrane Collaboration, and it’s bad news for the statin-makers — partly because the analysis itself isn’t flattering, and partly because the Cochrane Collaboration is a highly-respected organization whose work is considered both thorough and unbiased. Consequently, their report has generated quite a bit of media coverage. I’ve already read articles in the UK Telegraph (two), TIME’s online version, the Los Angeles Times, Miller McCune, and Reuter’s Health, among others.
If we piece together quotes from the articles, we end up with a nice summary of the statin story. Let’s start with how and why they became the best-selling drugs of all time:
Back in 1975, Henry Gadsden, the chief executive of the drug company Merck, expressed his frustration that the market for his company’s products was limited to those with some treatable illness. Ideally, he said, he would like to “sell to everyone”.
Three decades later, his dream would seem to have come true - epitomised by the most profitable class of drugs ever discovered, the cholesterol-lowering statins that are taken by an estimated seven million people in Britain, and tens of millions worldwide.
Yup, Merck and the other pharmaceuticals wanted to sell drugs to healthy people, and by gosh, they finally figured out how to do it.
The story starts with the arrival of “cholesterol consciousness”: the thesis that those indulging in (for example) bacon and eggs for breakfast boosted the cholesterol level in the blood, causing the arteries to become narrow, and making a heart attack more likely.
Although this idea has its critics, there is no doubt that the small proportion of the population with a genetic predisposition towards high cholesterol levels are at greater risk of circulatory disorders. Encouraging them to switch to a healthy diet had failed to lower that risk - so the idea gained ground that cholesterol-lowering drugs might be the answer.
The small proportion of the population with a genetic predisposition are those with familial hyperlipidemia. Their LDL is extraordinarily high because their LDL receptors don’t work and therefore don’t remove LDL from the bloodstream. Cholesterol-lowering drugs were shown to reduce their rate of heart disease by a teeny, tiny bit. From that result, the medical community decided cholesterol is a killer and we should all stop eating bacon and eggs — even though low-fat diets didn’t do diddly for the people with hyperlipidemia. Go figure.
An even more important factor, especially in the US, was the drive to establish “clinical practice guidelines”, under which panels would set the optimal treatment for any given condition. Successive guidelines have forced the “normal” level of cholesterol ever lower, resulting in leaps in the numbers deemed eligible for treatment. In the US, the figure went from 15 million to 40 million.
That’s how you sell drugs to healthy people: redefine normal cholesterol levels as dangerous. Among the un-medicated population, average total cholesterol was around 220 a few decades ago. Doctors rarely warned patients about heart disease unless their cholesterol was 250 or higher. But if 220 was the average, how did the new “normal” end up being 200?
After it was pointed out that those responsible for the most recent guidelines had failed to declare any potential conflicts of interest, it subsequently emerged that most of them had received research grants or consultancy fees from the drug companies involved in manufacturing statins.
That’s how. By declaring 200 to be the target level for cholesterol, the researchers (ahem, ahem) who wrote the guidelines guaranteed their paymasters millions of new customers.
Not surprisingly, quite a few clinical studies eventually concluded that statins prevent heart disease. I say “not surprisingly” because nearly all the studies were funded and conducted by the pharmaceutical companies. According to the Cochrane review, the studies might’ve been (surprise!) skewed to exaggerate the benefits and minimize the side effects:
In particular, while all the studies focused on benefits, only half provided information on the side effects of the drugs, said Dr. Shah Ebrahim, whose group’s findings are published by the Cochrane Collaboration, an international organization that evaluates medical research.
“There is evidence that the reports cherry-picked the best outcomes for presentation,” he added, “which will tend to inflate apparent benefits of treatment.”
While there appeared to be no difference in side effects between trials participants taking dummy pills and statins, the researchers say those results aren’t credible.
“Any appraisal we can make of adverse events is biased by failure to report these events,” Ebrahim said in an e-mail to Reuters Health. “We believe that trial funders, investigators and journal editors have failed to provide adequate information to doctors and their patients to assess the benefits and harms of statins in primary prevention.”
The good news is that while Merck and Pfizer may not report on negative side effects, more media outlets are:
Dr. Greg Burns (not his real name) is a 72-year-old retired radiologist living in Connecticut. Until early last year, he ran with his dog at canine agility meets, skied, ice skated and played 18 holes of golf. He is now unable to walk and is taking a course of medication that will postpone, by a few months, his death.
Burns’ rapid decline began in December 2007 when he suffered a short-acting stroke from which he fully recovered. His cholesterol level was elevated and so as a preventative measure his doctor prescribed a 20mg daily dose of Crestor, a cholesterol-lowering drug in the “statin” class.
A few months after beginning Crestor, Burns developed muscle cramps. He was assured by his doctors that these were not serious side effects of taking the drug. But in December 2008 when tests showed that his creatine phosphokinase - an enzyme that is released into the blood stream when muscle cells are damaged - was elevated, Dr. Burns stopped taking Crestor. When his enzyme levels returned to normal, he began taking Pravachol, another statin drug. He quickly developed weakness in his lower legs and a right foot drop.
Mayo Clinic cardiologists acknowledge that the side effects of statin drugs can include muscle pain, extreme fatigue, liver damage, digestive problems and neurological damage including memory loss.
Of course, not everyone who takes statins will experience side effects, so it’s a question of balancing benefits and risks, just like with any other drug. So let’s look at the supposed benefits.
If you’ve seen Lipitor ads on TV (and if you haven’t, it means you don’t watch TV), you know Pfizer claims Lipitor reduces the rate of heart attacks by 36%. As I’ve explained in previous posts, that figure may sound impressive, but basically it means that during the clinical trials, three out of every 100 men who took a placebo had a heart attack, while slightly less than two out of every 100 men who took Lipitor had a heart attack. So for every 100 men treated for ten years, we’re preventing (in theory) one heart attack. That’s one heart attack, not necessarily one death.
But even those unimpressive results were found only among with men with existing heart disease or multiple risk factors for heart disease — not among women, and not among otherwise healthy people who happen to have high cholesterol.
But of course, statins didn’t become the most profitable drugs in history by being prescribed solely to men with existing heart disease. Nope, statins became a cash cow when doctors started prescribing them to pretty much everybody whose cholesterol is above 200. (In the UK, you can even buy your future muscle or memory problems over the counter — yippee!)
The theory, of course, was that statins could prevent heart disease from developing in the first place, otherwise known as “primary prevention.” The Cochrane report casts more than a little doubt on that theory, as several media articles pointed out:
An authoritative review shows there is little evidence that the cholesterol-lowering drugs protect people who are not already at a high risk of heart disease.
Experts who advocate the use of statins say they have helped prolong thousands of lives by preventing heart attacks and other cardiovascular events. But a wide-ranging review of previous studies, published today in the journal The Cochrane Library, urges “caution” among GPs who prescribe them. It concludes that there is no “strong evidence” to suggest that statins reduce coronary heart disease deaths among those who have not suffered a heart attack or other cardiovascular event in the past.
Shah Ebrahim, a professor of public health at the London School of Hygiene and Tropical Medicine, who co-wrote the report, called on doctors to stop giving patients the drugs unnecessarily.
Just one life is currently saved for every 1,000 people who take them each year, the report says.
Great … so to prevent (in theory) one fatal heart attack among every 1,000 people who take statins, we’ve created lord-only-knows-how-many cases of muscle degeneration, memory loss, kidney failure, erectile dysfunction and liver damage. Of course, that works out well for Big Pharma — they sell drugs to treat those conditions, too.
I’ve said it before, and I’ll say it again: statins are some of the worst drugs ever. I’m just happy to see more people in the news media are catching on.

It's Those Statins Again !

Good article from

"View from the hill"

Statins, Pregnancy, Sepsis, Cancer, Heart Failure: a Critical Analysis:

Over the last few decades, the American pharmaceutical industry (henceforth, "Big Pharma") has applied a very successful formula to market fear and convert it into a multi-billion dollar industry. The algorithm goes like this:

1. find a substance whose concentration can be measured cheaply
2. find a prevalent disease whose presence correlates with a high concentration of that substance
3. find a drug that reduces the concentration of that substance
4. advertise aggressively to the general public and medical professionals, claiming a miracle cure.

In a substitution of variables, the substance is cholesterol, the disease is heart disease, and the drug is Lipitor, and, voila! Through aggressive advertising campaigns, Big Pharma has managed to convince the American public and the American doctors that statin drugs are the best thing since sliced bread.

But are they right? I think the evidence shows that very few people currently taking statin drugs are actually benefiting from them. Furthermore, many of them are actually worse off than they would have been had they never been on statins. Below, I will argue that any benefits incurred in combating heart disease are more than offset by increased susceptibility to fetal damage, toxic infection, and cancer.

...
Essentially, by taking a statin, you are shifting the odds on what you die of. Pay the money, suffer the side effects, and as a result you may end up dying of cancer or a runaway infection before you would have died of heart disease if you had never taken the drug in the first place.
...

Read the full article by Dr.Stephanie Seneff, a Principal Research Scientist at the Massachusetts Institute of Technology here.

15% of Population at High Risk for Statin Injury

In an August 2008 article from Wellness Resources a NEJM study is referenced stating:


"Scientists have uncovered an alteration in a gene that causes statin drugs to be more readily absorbed by the liver, thereby making the drug very toxic. 15% of our population has the risk-related gene variant."


The article concludes...


Let’s look at it another way. For those who enjoy playing Russian roulette the odds are 1 in 6, close to 15%. How many people do you know who play Russian roulette? How many people do you know who take statins? Big Pharma and its salesman are more than willing to play this deadly game with the American public, as they rake in 20 billion in sales every year on this one class of medication. Whatever happened to “first do no harm.”

• Do you take a statin drug?
• Had your genes checked?
• Do you have the rs4363657 single-nucleotide polymorphism (SNP) located within SLCO1B1 on chromosome 12?

Statins Can Injure If You Have a Common Gene Variant

Statins and cancer - again

NewsTarget author Byron J. Richards, a Board-Certified Clinical Nutritionist writes an article about the link between statin induced low cholesterol and cancer. His first paragraph opens this way...

"In a major shot fired across the bow of the statin marketing machine, the levels of LDL cholesterol that are the artificial targets of "health" promoted by the American Heart Association (AHA) are now found to be associated with a significant increased risk of cancer and death."

He further says...

"The Vytorin fraud has pointed out quite clearly that lowering LDL cholesterol to very low levels does not reduce cardiovascular disease. Another Vytorin study also shows doing so increases cancer risk by 64%. The new study paints the clear picture that lowering LDL too low actually increases the rate of death from any cause. This new study also points out the statistical shenanigans that the statin industry uses to hide the actual risks of these drugs in the studies that have been published."

Read the complete article here.

Link to full Canadian Medical Association Journal article here.