My last post laid out some of the challenges we will face from the insurance and pharmaceutical industries while pursuing a universal single payer health care system.  One of my themes was that 'money talks'.  Today I'm going to talk about how the pharmaceutical industry is gobbling a piece of our $2 Trillion national health care pie we may not have even noticed was missing.  Aside from the pharmaceutical companies lobbying and PR efforts, drug money also talks in the way it attains FDA approval for drugs that show no significant improvement over drugs that are all ready available or whose claims of efficacy are dubious.  In the New York Review of Books, Marcia Angell, recaps three books chronicling the collusion between pharmaceutical manufacturers and the academic institutions involved in validating the effectiveness of our prescription drugs, (I quote and paraphrase her article herein liberally).  Like what has been revealed in the financial sector of our economy, greed plays a major role in the subordination of what we might have expected from the pharmaceutical industry, researchers, academic research institutions, and our own Food and Drug Administration.

The article and books chronicle multiple instances of conflict of interest, (COI), between the pharmaceutical industry, drug researchers, and the academic institutions responsible for validating those drugs' usefulness.  Research agreements between drug manufacturers and academicians generally require as a condition of funding that the company be intimately involved in the experimental design, analysis, and writing of the academic papers.  Researchers with a solid academic reputation, or Key Opinion Leaders, (KOLs), are highly sought after by the drug industry in order to project the imprimatur of credibility to the research.  Financial remuneration is usually proportional to the researcher's academic reputation. 

For example, Dr. J.L. Biederman, ( a professor of psychiatric research at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital), conducted research that led to the creation of a market for drugs for patients as young as 2 years of age in the treatment of bipolar disorder.  His studies have been described as "so small and loosely designed that they were largely inconclusive".  Last June it was revealed that Biederman had received $1.6 Million from the drug manufacturers who produce and market the drug cocktail he advocates.  Two of Biederman's colleagues received similar amounts.  Winning the Nobel Prize in chemistry pales by comparison to the financial rewards offered by drug companies to academic researchers.

Dr. Alan F. Schatzberg, chair of Stanford's psychiatry department and president-elect of the American Psychiatric Association controlled more than $6 million worth of stock in Corcept Therapeutics, a company he cofounded that is testing mifepristone--the abortion drug otherwise known as RU-486--as a treatment for psychotic depression.  Schatzberg has authored three papers as principle investigator on the use of mifepristone as a treatment for psychotic depression.  

"In 2004, after the National Cholesterol Education Program called for sharply lowering the desired levels of "bad" cholesterol, it was revealed that eight of nine members of the panel writing the recommendations had financial ties to the makers of cholesterol-lowering drugs".


In addition to these examples, 55% of contributors to the most recent edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM - the diagnostic and treatment bible for psychological and psychiatric disorders), had financial ties to drug companies.



Conflict of interest transcends the bounds of individual researchers and inserts itself into the relationship of the academic institutions conducting drug research through the creation of endowed chairs in medical facilities across America.  This, coupled with the controlling agreements written by the drug companies can often result in negative conclusions being suppressed or 'tweaked' to put a positive spin on such.  In clinical trials which are conducted to attain approval by the FDA for a drugs use, the results of what can be many trials are submitted, and as long as one or two are positive, (show effectiveness without serious risk), the drug is usually approved even if all the other trials are negative.  In this way drugs that may be marginally effective for their stated claims enter the market.  Bias becomes endemic:

A review of seventy-four clinical trials of antidepressants, for example, found that thirty-seven of thirty-eight positive studies were published.  But of the thirty-six negative studies, thirty-three were either not published or published in a form that conveyed a positive outcome.

The penalty for malfeasance by the pharmaceutical industry is outweighed by the astronomical profits they can make.   Paxil, an antidepressant, eventually came to trial on the charge that it was "ineffective and possibly harmful to children".   The manufacturer agreed to settle charges of consumer fraud for $2.4 million.  Given annual sales of Paxil at the time ($2.7 Billion), the payment amounted to little more than a slap on the wrist.  

A generation ago, medical schools didn't have extensive financial dealings with the industry, and faculty investigators who carried out industry-sponsored research generally did not have other financial ties to their sponsors.  A recent survey found that 2/3 of academic medical schools hold equity stakes in companies that sponsor research with them.   Another study discovered that 2/3 of department chairs received departmental income, while 3/5 received personal income from drug manufacturers.

Melody Petersen, a reporter for The New York Times, explains the many ways, legal and illegal, that drug companies can create "blockbusters" (drugs with yearly sales of over a billion dollars) and the essential role that Key Opinion Leaders play.

Her main example is Neurontin, which was initially approved only for a very narrow use--to treat epilepsy when other drugs failed to control seizures. By paying academic experts to put their names on articles extolling Neurontin for other uses--bipolar disease, post-traumatic stress disorder, insomnia, restless legs syndrome, hot flashes, migraines, tension headaches, and more--and by funding conferences at which these uses were promoted, the manufacturer was able to parlay the drug into a blockbuster, with sales of $2.7 billion in 2003. The following year, in a case covered extensively by Petersen for the Times, Pfizer pleaded guilty to illegal marketing and agreed to pay $430 million to resolve the criminal and civil charges against it. A lot of money, but for Pfizer, it was just the cost of doing business, and well worth it because Neurontin continued to be used like an all-purpose tonic, generating billions of dollars in annual sales.

The brass ring in the drug business is creating an altogether new disease.  Doing so can be extremely lucrative for drug manufacturers.   Christopher Lane uses shyness as his case study of disease-mongering in psychiatry.

Shyness as a psychiatric illness made its debut as "social phobia" in DSM-III in 1980, but was said to be rare. By 1994, when DSM-IV was published, it had become "social anxiety disorder," now said to be extremely common. According to Lane, GlaxoSmithKline, hoping to boost sales for its antidepressant, Paxil, decided to promote social anxiety disorder as "a severe medical condition." In 1999, the company received FDA approval to market the drug for social anxiety disorder. It launched an extensive media campaign to do it, including posters in bus shelters across the country showing forlorn individuals and the words "Imagine being allergic to people...," and sales soared. Barry Brand, Paxil's product director, was quoted as saying, "Every marketer's dream is to find an unidentified or unknown market and develop it. That's what we were able to do with social anxiety disorder."

Psychoactive drugs comprise some of the biggest 'blockbusters to date.

Children are particularly vulnerable targets. What parents dare say "No" when a physician says their difficult child is sick and recommends drug treatment? We are now in the midst of an apparent epidemic of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity disorder as the most publicized condition in childhood), with a forty-fold increase in the diagnosis between 1994 and 2003. These children are often treated with multiple drugs off-label, [for conditions for which the drug has not been approved by the FDA], many of which, whatever their other properties, are sedating, and nearly all of which have potentially serious side effects."

The majority of big pharmaceutical manufacturers have settled charges of fraud and other offenses. While the penalties are sometimes enormous, they are still dwarfed by the profits realized and as such do not act as a effective deterrent.

"Physicians, medical schools, and professional organizations have no such excuse, since their only fiduciary responsibility is to patients. The mission of medical schools and teaching hospitals--and what justifies their tax-exempt status--is to educate the next generation of physicians, carry out scientifically important research, and care for the sickest members of society. It is not to enter into lucrative commercial alliances with the pharmaceutical industry. As reprehensible as many industry practices are, I believe the behavior of much of the medical profession is even more culpable. Drug companies are not charities; they expect something in return for the money they spend, and they evidently get it or they wouldn't keep paying."

The majority of big pharmaceutical manufacturers have settled charges of fraud and other offenses.  While the penalties are sometimes enormous, they are still dwarfed by the profits realized and as such do not act as a effective deterrent.

The necessary reforms to restore integrity to clinical research are myriad.  New legislation regarding conflict of interest and changes in FDA regulations are the most apparent.  There is an obvious need for the medical profession to forgo drug industry money entirely. Industry-academic collaboration can make important scientific contributions, notably in carrying out basic research rather than clinical trials.  The probability of COI in clinical trials is too great for the current model of the drug industry/medical profession to continue. Financial support of medical research should have no strings attached, especially control by drug manufacturers over the design, interpretation, and publication of results.

Angell concludes: 

After much unfavorable publicity, medical schools and professional organizations are beginning to talk about controlling conflicts of interest, but so far the response has been tepid. They consistently refer to "potential" conflicts of interest, as though that were different from the real thing, and about disclosing and "managing" them, not about prohibiting them. In short, there seems to be a desire to eliminate the smell of corruption, while keeping the money. Breaking the dependence of the medical profession on the pharmaceutical industry will take more than appointing committees and other gestures. It will take a sharp break from an extremely lucrative pattern of behavior. But if the medical profession does not put an end to this corruption voluntarily, it will lose the confidence of the public, and the government will step in and impose regulation. No one in medicine wants that.

So here we are, with the monied interests buying control over our health care yet again. The drug companies continue to pitch their snake oil curatives to us, but with the financial embedding of the manufacturers in the research community we as health care consumers can come up with snake eyes in our drug treatments all too often. While we're busy pursuing our livelihood, trying to make ends meet, making sure the bottom doesn't drop out of our own little world, the big drug companies are quietly going about business as usual, spending huge amounts of money designing new ways to extract cash from the public. Through the manipulation of research, and its selective publication, we are sitting ducks,




waiting for the big drug companies to draw a bead on us, so they can sell us a drug for a condition that may not exist, and we may not have;  A drug that may not be effective in treating the disease anyway.  They're working on one that's tailor made for each and every one of us.  When we go to the hardware store, we notice if an item costs more, or doesn't do what it was designed to do, and we can take it back for a refund or shop for a better product.  Medications are inherently different.  We depend on our physicians to relay accurate information regarding our drugs to us.  If that trust is compromised, we have no real way of evaluating decisions regarding our medications. 

Greed is beginning to appear to be a hallmark of unbridled capitalism.  If we allow it to happen, you can bet that it will.  Between the 'tens of billions' of dollars spent manipulating the pharmaceutical market by the big drug companies, and the equally astounding amount they spend on marketing their products on television, radio, print, and the web, there is an incredible inefficiency and cost built into our current health care system.  Estimates of the drug industry's advertising expenditures alone reached $57 Billion in 2002.  Some of these expenditures  can be trimmed from health care costs in the US.  Government "of the people, by the people, and for the people" is not a given in the US.  It is a participation sport so to speak.  Will we insist our government protect our financial and health care interests by legislating conflict of interest controls regarding pharmaceuticals and reforming FDA licensing procedures, or will we lapse into a societal coma while the special interests rifle our pockets?

Contact your congressperson and senators and let them know how you feel.

Note:  Unattributed quotes are from Marcia Angell's article in the New York Review of Books