Monday, June 04, 2007

Root Strikers

Root strikers"There are a thousand hacking at the branches of evil to one who is striking at the root"
Henry David Thoreau

This post is about our patients and their questions.
It is about the honesty of our profession.

Roy Poses at Health Care Renewal drew attention to an excellent article in an obscure media source, the Berkshire Eagle (located in the Bershire mountains of Massachusetts). The reporter, Barbara Quart, experienced something of a personal odyssey after attending a medical research convention. My interest in her story was enhanced by the fact that the meeting she attended was the 7th International Osteoporosis Symposium in Washington, D.C. This is exactly the sort of high-profile osteoporosis meeting I would previously have attended with some frequency. She writes well about my colleagues and the integrity of my clinical speciality. Her thought provoking article is reproduced following my comments.

As a profession we have a long and effective history of dealing with critics. We are of course scientists. We sell our services under the banner of science. We promote the wares of industry under the banner of science. So, when Prince Charles addressed the World Health Assembly in May 2006 to argue that homeopathy should be offered as part of "integrated healthcare" we could respond with ease. Anticipating his speech, we in "scientific" medicine struck back with an open letter expressing concern about the use of "unproven or disproved" treatments, and the need to reserve NHS funds for "treatments that are based on solid evidence". So much so good.

The problem we face is that the most important patient criticism of our profession is not about "alternative" medicine or homeopathy. Critics strike at the core of what we do. Their questions are about science. They question the quality, transparency and honesty of our science. And they do so with good reason. We ignore these patients and these questions at our peril.

Some of these individuals are patients. Others have lost family members only to discover that information about medicines had been hidden with the collusion of regulators. The questions they ask and the evasive dishonest answers they receive speak volumes. They have asked serious and pressing questions of doctors, companies, regulators and governments. I have watched with shame as they have received "answers" which have no scientific or linguistic meaning. The answering reveals a leadership of our profession that has lost its way. It reveals bullying appearance-based regulatory systems in which box-ticking and red tape trumps the need for scientific or personal integrity. It reveals that concerns raised about highly placed individuals are obscured by a network of powerful colleagues.

There are no open letters of concern about "solid evidence" this time.

It is worth reading the careful writings and correspondence of some of these root strikers. Why are we as doctors not asking those same questions, or teaching our students anything about real integrity? Perhaps we are fearful of speaking out for honest science. The questions that need answering are obvious ones. When patients lose trust in the integrity of the science upon which they depend, we may never be able to recover our status as a profession.

As Roy poses writes:

"if physicians don't give up the "nifty perks," and appearances in the "satellite sessions" that "subtly but unmistakably sell the drug,", an outraged public will and should take harsh measures to make sure we do give them up.

Here are a few root strikers. Just ordinary people asking ordinary questions:
Seroxat Secrets
Bob Fiddaman
Vera Sharav
Millie Kieve
Colin Downes-Grainger

And that excellent article by Barbara Quart about my bone colleagues is below:
Big Pharma is big dog at symposium
By Barbara Quart
(Original Article)

May 28 2007 NEW YORK LATE LAST month I attended the 7th International Osteoporosis Symposium in Washington, D.C. I thought I'd learn a lot that I could then pass on to other older women in the Berkshires, many as little conscious of osteoporosis as I had been, and I hoped to get clearer what to do about my own diagnosis, and the urgently prescribed medication for it, which I have refused for a year now.

The event was basically a five-day non-stop education — some might call it a fancy sales job, or even indoctrination — by MDs for MDs (also physical therapists and other health professionals). From 8 a.m. to 9 p.m., talks and panels, lots of exciting information, in grand hotel ballrooms. All meals provided — dinners especially nice, supplied by the drug companies — plus nifty perks like a handsome tote bag emblazoned with "Lilly" (maker of Forteo, scariest of the drugs), and a beautiful pen inscribed "Fosamax," the blockbuster seller. A very different world from the pretzels and chips and cheap white wine of my own decades of university English literature meetings. I feel grateful now, thinking back, that one couldn't be for sale in my profession.

After I came home I thought for a while that things seemed clearer. Just about everyone who spoke or whom I spoke to seemed of one mind: this is a really bad disease, undertreated, it desperately needs to be publicized, diagnosed (give a DEXA scan to every woman over 65), and medicated, or it will wreak devastation. And I heard about several memorable instances of osteoporosis-caused spinal collapse, hip collapse, chronic horrible pain, hideous operations.

So my first draft of this article read like the NIH ad in the recent Sunday Times Magazine devoted to older women. I crammed it full of data, carefully defining the disease (bone thinning, especially after menopause), listed risk factors (like family history and smoking), noted how men get it too but later and to a lesser degree, urged kale and yogurt, heavy vitamin D3, exercise overseen by a really skilled physical therapist (working with amazing Jill Esterson of Great Barrington was the best thing I did this last year).

I couldn't however share the leadership MDs' enthusiasm for the drugs as good, safe, effective; nor their repeated deploring of "non-compliance" (naughty patients who drop their meds). The scolding of the "non-compliant" seemed to have priority at the symposium over the exciting talks by research scientists, and no speaker dealt with why so many people go off these drugs or are reluctant, like me, to take them in the first place.

There was a giant image of jaw necrosis: the white patch of exposed bone in the mouth from taking a bisphosphonate (Fosamax or Actonel) — though no mention of the horrific pain, or how some cases heal but others don't, and for those there is no help. And little or no mention of esophageal problems, from heartburn to severe terrifying esophagitis. Nor leg pain, eye pain, other "adverse events."

The tone was always upbeat, a kind of beating the drum, and the line between the drug companies and the MDs uncomfortably unclear. True, the dinner panels are called "industry sponsored satellite sessions" — but the same leadership MDs who are major speakers during the day, and whose names keep appearing on the important research in the major medical journals, are the same ones on the evening "satellite" sessions that subtly but unmistakably sell the drug — Forteo, Actonel, Fosamax — sponsoring the session.

Health professionals I respect argue that osteoporosis is being hyped to create a massive new market to take over where the disastrous Hormone Replacement Therapy left off, all the money it generated vanishing. True or not, money weaves through all of this in disconcerting ways.

Before I left for Washington, I stumbled upon an on-line story in Slate about two Sheffield University (England) researchers conducting clinical trials of Actonel (second in sales to Fosamax) for Proctor & Gamble for $250,000. But P&G took away the final data, denied them access, wanted to ghostwrite the conclusions for publication under their signatures.

One of the scientists, Aubrey Blumsohn, refused and insisted on seeing the data first, only to find that 40 percent had been removed. This a year after medical journal editors "warned that growing industry interference with academic research (from study design to data analysis and publication) was threatening the objectivity and trustworthiness of medical research."

As former New England Journal of Medicine Editor Marcia Angell, MD of Harvard Medical School and author of a book on the subject, states that drug companies are "involved intimately in every detail of the research" for new drugs, and "they design the research so that their drugs look better than they really are." How could one ever again trust any scientific study, in however reputable a journal? What won't I know about?

So in my own looking for some truth I could rest my decision on, I discovered that even the truths I thought I already had are probably not trustworthy. Compromised doctors. Compromised data. Flying blind indeed.

So perhaps it's not surprising that what stays with me most from the symposium is the only critical voice I heard in five days, a gray-bearded man who spoke with quiet grace after the final session. An orthopedic surgeon from a small town near Pittsburgh, he said he feared we are walking into yet another medical disaster of huge proportions and the people treated will be the ones who will pay the price. He himself prescribes these drugs because he feels something must be done to intervene with continual bone loss in his elderly patients. But it will be another 15 years before we know what we're doing. When you take this medication, he said to me later, you should see yourself as being in yet another clinical trial.

Finally, I contacted the medical consumer advocate whose sanity in print I've long valued. BMD numbers are critical, she says, and you must assess what exactly the drug will do for you. How effectively does it prevent fractures? Percentages can be made to look large but may actually be very small, barely more than the placebo effect, perhaps the same as the chance of an esophageal ulcer. Is that worth the risk? The whole industry is trying to terrify you, she says.

My own conclusions? I feel I must take that pill, but I will do so angrily.

I am angry that this richest of American industries uses its vast wealth far less for research to make better, less dangerous drugs, than to buy off doctors; to plaster misleading ads everywhere; to dispatch armies of salesmen and lobbyists; and to manipulate and thus destroy the meaning of scientific research results. Still, as I write this, stories and editorials are suddenly erupting in the Times about MD/drug company collusion; and Vermont's Bernie Sanders eloquently attacked Big Pharma in the Senate itself as the very worst of a long list of the most powerful, greediest special interests in America.

So maybe there's hope.

But for now, dear reader, sorry, but you're entirely on your own.
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InformaticsMD said...

Some of these individuals are patients. Others have lost family members only to discover that information about medicines had been hidden with the collusion of regulators. The questions they ask and the evasive dishonest answers they receive speak volumes.

As I wrote at "Journalistic Malpractice, or Pharmaceutical Malpractice?":

The cause of the attacks [on the pharma industry] from venerable journals such as the NEJM is not ideology, but mistrust. The pharmaceutical industry has taken societal trust - a must for any industry to be successful - and blown it out of the water. In fact, the public mistrust of the pharmaceutical industry has been well-earned.

Anonymous said...

I think what you have written is excellent. The problem I see however as regards patient demands for something better, was reflected in the poll the MHRA sponsored in 2006 - the overwhelming percentage of people who trust their doctors and the shaming percentage of doctors who believe the MHRA does a good job, even though many do not even know what the MHRA does.

It's an uphill struggle - the establishment of medicine is very good at freezing out patients and seemingly finds no difficulty in doing the same to insiders like yourself, Healy, Ashton and Collier. Still we all must try to keep the cynicism under control.


Anonymous said...
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Anonymous said...

This is what Prof Ashton said in a talk entitled THE ROLE OF THE PHARMACEUTICAL COMPANIES


Mental Health North East (MHNE) AGM and Conference,
Bowburn Community Centre, Durham

Professor C Heather Ashton, DM, FRCP
May 18, 2007

".......And there was a change in the way drug companies were run. A pharmacologist working for Sanofi Pharmaceuticals said: "In the beginning, the pharmaceutical industry was run by chemists ... This was not so bad. [But] now most of them are run by people with MBAs, or things like that, people who could be the chief executive of Renault, Volvo or anything. They don't know about drugs." But clearly, they do know where the market is.

Another quote from the same pharmacologist: "When you find a drug that is really active on one receptor .... The problem comes when you present it to the financial analyst. You say 'I have a new drug, a very interesting antagonist of '[receptor X]' 'Good', says the financial analyst, what is the market?....' So you have to decide for what indication the drug should be developed, at what dosage, what will be the price of the drug and so on. This is totally stupid, but it's what you have to do." So it is the drug company chemist or pharmacologist who decides for what indication the drug will be developed. If the indication is not there, it must be created - in other words a disease suitable for the drug must be invented.

One of the many examples of this process was the development in the 1970s of Xanax (alprazolam), a very potent benzodiazepine, for panic disorder. The marketing of this drug involved a clear strategy to take advantage of the medical profession's current confusion about the classification of anxiety disorders and to create a perception that the drug (Xanax) had special and unique properties that would capture a market share of benzodiazepines that would displace diazepam (Valium) from the top position. There was in fact nothing unique in this regard about Xanax. All the benzodiazepines including Valium were good for panic attacks...."

Fid said...

When I first set out to research the medication I had been having problems with I was surprised to learn that I was one of many.

I turned to the MHRA and expected answers. Those answers never came. In fact, many of my questions were deemed unanswerable by the MHRA and were filed under the exemption rule of this and that.

When one cannot get an answer to a question one will pursue the truth - this is what I have been trying to do.

It has been a journey that has opened my eyes to the big bad world of pharma and politics and a journey that I will continue until I reach my destination - a lil ol place called 'Truth'

It's a great pity that there aren't more people out there in cyber land who want to stand up and be counted - those that do - I salute, yourself included Aubrey.


Anonymous said...

When Competition Does Not Benefit Consumers

“But corruption is neither need based or greed based. It’s simply opportunity based.” -----

Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.

It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government because that would drastically limit if not eliminate innovation as well as our health care choices, both from the perspective of the doctor and the patient, so the public has been told often. So, the public’s health would be limited and possibly harmed. As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason.
As it has turned out, the pharmaceutical industry has appeared to do this on their own, overall.

Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients. Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief. This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as me too drugs.

These drugs essentially make small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original in order to obtain patent rights. This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a potential med to be superior to a placebo in mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others.

And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least. For example, statin drugs, for high cholesterol patients, is a 20 billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds. The differences overall are minor once again with most me too drugs. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class. Finally, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class that are all essentially the same in regards to their treatment abilities for patients with such disease states.

Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, the me too drugs occasionally are beneficial for patients, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies.
Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is normally demonstrated with other industries and is the apex of business operations. This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science.

Innovation, along with ethics, use to define this industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health. Yet hopefully, such historical qualities of drug companies will return some time.

Dan Abshear