Monday, July 30, 2007

What's wrong with cancer medicine? (Cont.)

A front-page story from The New York Times, "Drug Sales Bring Huge Profits, and Scrutiny, to Cancer Doctors," published in its Sunday, January 26, 2003 edition, details how cancer doctors--oncologists--make most of their money. "At a time when overall spending on prescription drugs is soaring," the article begins, "cancer specialists are pocketing hundreds of millions of dollars each year by selling drugs to patients." The article goes on to describe the "cancer concession," the practice by cancer doctors of obtaining cancer drugs at low prices from multiple sources and administering--selling--them to their office patients at exceedingly high "mark-ups." The article states that cancer doctors "can make huge sums--often the majority of their practice revenue" from the difference between what they pay "wholesalers, discounters and pharmaceutical companies" and what they charge "patients, insurers and government programs." It has been estimated, the article states, that "oncologists in private practice typically make two-thirds of their practice revenue" from the "cancer concession."

That's a lot of money, considering that cancer doctors often just out of residency can generate upwards of $500,000 for their practice annually. Naturally, the more expensive cancer drugs that are administered, the more income generated. Administration of cancer drugs such as Avastin, Lucentis, Revlimid, Sutent, Vectibix and Erbitux--at average per-patient costs of $51,000, $48,000, $67,000,$46,500, $36,000 and $18,000 (per month), respectively--can generate large sums of money.

The New York Times article equally points out that this practice by cancer doctors "creates a potential conflict of interest for oncologists, who must help patients decide whether to undergo or continue chemotherapy if it is not proving effective"; that the "inappropriate" sales of chemotherapy to patients in the last stages of cancer was rife within oncology practice (for example, it was found in an audit of a Massachusetts study that "a third of the patients received chemotherapy in the last six months of their lives, even when their cancers were considered unresponsive to chemotherapy"); that the reason for this widespread practice was possibly related to the profit motive. "All evidence suggests that doctors do respond to money," a clinical faculty member at the University of Michigan Medical Center was quoted.

Today the treatment of human malignancy has become big business. It has been estimated that the conglomerate of cancer therapy, cancer research, cancer care, cancer administration and cancer pharmaceuticals totals $200 billion per year in the United States alone. The treatment of patients, in a real sense, has become business-driven. Gone are the days when cancer doctors would tailor individual treatments to patients as they deemed necessary or desirable; today instead, patients are placed on what are called 'protocols'--single or combinations of anticancer drugs that are usually experimental in nature. The 'protocols' very frequently emanate from the National Cancer Institute (NCI), which in turn subsidizes oncology group practices throughout the United States--to the tune of hundreds of millions of dollars each year. This puts great pressure of individual oncologists to put away their own treatment initiatives in favor of one or another protocol. Typically the cancer drugs used in a protocol--commonly newly developed from pharmaceutical companies or from the NCI--are very expensive.

Oncologists who are confronted with a choice of treating a patient individually, perhaps with an inexpensive new agent, or placing the patient on a protocol, frequently opt for the latter. Not wishing to risk the disfavor of their colleagues, they may be reluctant to place the patient on any new agent--inexpensive or not--that may threaten the lucrative incomes their practices have come to generate and thus kill the goose that lays the golden egg.

It is precisely with the advent of 'big business' as cancer practice that loss of innovation--and diversity of effective cancer treatment--has occurred. In this regard the public is regularly deceived. Every week news broadcasts, and headlines, trumpet new cancer breakthroughs. But where are they? How do these stories get on television? The answer is--that they are put there. By hired medical publicists or skilled public relations people. And if one looks carefully enough, many of these 'breakthroughs' are being publicized at the very time the medical groups responsible for them are being considered for major grants from the federal government--the NCI or National Science Foundation. Or a branch of the federal health establishment is petitioning Congress for increased budgetary appropriations. And while the 'hope' generated by these news stories so often vanishes, their underlying fundamentals usually succeed. For the reasons behind these broadcasts and headlines frequently have nothing to do with innovative advances, but with exerting public pressure on funding mechanisms to increase the 'business' of cancer research and treatment. The 'big breakthroughs' fade. But 'big business' prevails.

Today we have experienced a "shift" from high scientific achievement to big money achievement in cancer. Individual cancer practice is corrupted by money, and cancer science has become corrupted by money. It is this factor--big money--that is one of the two chief reasons underlying the woeful lack of progress and significant treatment advances in cancer medicine.

The other chief factor for the lack of innovation in cancer treatment is the NCI--the National Cancer Institute, part of the federal government.

The National Cancer Institute is the single, largest, most powerful cancer institution on the face of the earth. Its budget--received directly from Congress since the National Cancer Act of 1971--currently exceeds $4.75 billion annually, dwarfing by far the annual budgets of all cancer research, cancer treatment, cancer education and cancer fund-raising agencies in the private sector combined. While twenty-five years ago organizations with smaller budgets but with prestigious scientific staff in the private sector were, to an extent, the 'tail that wags the dog' (the NCI), this is no longer the case. With its almost exponential growth in budget, program and funding, the NCI has emerged as the dominant force in all phases of cancer investigation and treatment.

The NCI directly funds all officially-designated cancer centers in the United States--and the personnel and projects ongoing in these centers; without the NCI these centers--and their programs--wouldn't exist. The NCI makes institutional grants available to medical centers, universities and academic institutions nationwide; without the NCI much of the faculties of these institutons--and their projects--would dry up. The NCI is the major granting agency for young scientists with innovative ideas as well as for established scientists with many ongoing projects; without the NCI these projects--and scientists--would disappear. NCI officials sit on the editorial boards of virtually every important cancer journal in the nation--and thus exercise strong influence as to what appears in the mainstream cancer literature. NCI has become a virtual tsunami, whose waves crash against the shores of all cancer research and treatment projects worldwide.

But the NCI is also a monopoly. And it does what all monopolies do--acts in restraint of trade. Acts in restraint of true innovation. For who on NCI's dole would dare challenge current scientific thinking and directives of those who occupy NCi's highest echelons and formulate policy? Where is the incentive for individual scientists to excel and what if their endeavors lead them in directions that are not welcome at these top levels of power?

Monopolies usually tend to quash incentive. That is because incentive is a function of competition. There is no competition in NCI operations--except for monies and position advancement. But monetary and position improvement have nothing to do with true scientific innovation.

True innovation is a function of competition of thought. There must be no single monolith. No single source of power so great as to intimidate scientists from submitting grant proposals that are 'unpopular,' proposals outside current mainstream scientific thought--frequently brilliant, unrestricted, challenging traditional scientific concepts--and often the source of large steps forward.

There must be several 'NCI's--each independent of the others--that would be in competition with one another and would be rewarded according to their discoveries. The most immediate--and fundamental--advantage of such a structure would be that no one person--or group of cronies--would have absolute control over what research gets funded, what drugs get tested, what papers get published.

Naturally, there would be drawbacks to such an arrangement. It could be argued, for example, that there would be much duplication of work--and thus waste of tax dollars. But duplication of work is not necessarily a bad thing. For different scientists working on similar projects can come up with far different results, depending on the mind-set of the scientist, serendipitous occurrences, etc. On more than one occasion individual scientists or a group in competition with others--working on the same project--have 'cracked the code' of discovery and cure, such as the isolation and purification of insulin, the development of the polio vaccine, the identification of human immunodeficiency virus (HIV) and more.

The brilliance of scientific discovery bringing large public benefits has always been based on a milieu of competition and incentive--the competition of ideas and the incentive and freedom to carry them out. Until the NCI's concentration of power is lost--and with it the inhibition of these aspects of human inquiry in which great discoveries reside--there will be little and few signifcant steps made in the defeat of cancer.

Thus big money and the NCI, our best hope for protection against cancer, are largely responsible for the treatment abyss surrounding this disease of the last 30 years. Big money has corrupted--and acted to dethrone--the primacy of high clinical and scientific achievement in favor of high money achievement. The NCI, and its centralization of power, paradoxically has acted to stifle new ideas, new advances and true innovation.

In my opinion, it is these two factors which have contributed majorly to the lack of progress in cancer medicine.

Thursday, July 19, 2007

What's wrong with cancer medicine?

In recent decades there has been a plethora of clinical advances--in heart medicine, in stroke, in diabetes and other endocrine diseases, in respiratory illnesses, in infectious disease, in orthopedics--but very little progress in the treatment of cancer. One only has to look around--at his neighbor, at his family member, at his workplace acquaintance, at his friend or loved one afflicted with such major cancers as lung, brain, gastrointestinal, even breast cancer--to know that those major killers have hardly been indented by modern medicine.

To be sure there have been scientific and clinical advances--duly reported by the medical media--made in the field of cancer research, but most of these advances have not resulted in any "transitional" gains that have really advanced clinical cancer treatment.

Yet the public has been made to think we are making great strides in the treatment of cancer. Night after night, week after week, our electronic media announce new scientific discoveries that "promise" to advance cancer treatment. And every so often we are reminded of the large "victories" being made in cancer survival. But one of these victories in overall survival is in "skin" cancer. What we are not told is that included in this category of cancers are "basal cell tumors," comprising by far the great majority of this group of cancers. The survival rate of basal cell cancers is almost 100%, no matter what medical action--if any--is taken. If one subtracts basal cell tumors from overall cancer survival, the overall survival rate dramatically decreases.

Several months ago it was announced that a major advance had been made in breast cancer, decreasing the incidence of this disease in postmenopausal women. But it turned out that this decrease was not due to any new advance but to tens of thousands of women giving up their monthly hormonal replacement therapy (HRT) which was being shown--contrary to their physicians' prior belief--to actually cause breast cancer. Thus this scientific "advance" was not a treatment advance at all but merely a deletion from therapy of a medication causing breast cancer.

Closely related to advances in the treatment of breast cancer are mammograms. Women, especially over 40, are recommended to have yearly mammograms. Mammograms are radiation and this form of radiation is well known for its life-saving benefits, in the form of early diagnosis. What is not so well known--and is at the heart of the continuing heated debate in the medical profession as to whether especially younger women should receive mammograms--is that radiation can also cause breast cancer. Even in the low doses in mammograms. Thus, while mammography's usefulness in the field of early diagnosis is not in dispute, it has been estimated by some epidemiologists and cancer statisticians that a single mammogram actually increases the cumulative likelihood of breast cancer in a woman by 0.3%.

Regional and national cancer fund-raising events--"walkathons," "marathons," "bike-athons," "races," "relays"--and the publicity given them also act to give the impression that the cure to cancer can be imminent. These events attract thousands of participants who contribute funds to the sponsoring organizations, believing sincerely that their efforts may help to bring about the "cure." But the tired truth is that the funds these events raise--reinforcing and strengthening the sponsoring organizations--frequently find themselves in the hands of the same old scientists and researchers, who sit on the same old federal and large private-sector granting (peer-review) committees of our cancer agencies, frequently for the same old projects or variations thereof.

In contrast to the rosy picture painted by our periodic promising communiques in the medical literature and medical media, qualified cancer experts have in fact affirmed that overall cancer survival has not significantly changed in the last 30 years.

What accounts for this woeful lack of progress?

There are two major causes of this tragic situation. One is money, the other is the way cancer funds are distributed. These will be discussed in detail in our next blog.

Wednesday, July 11, 2007

"Ask your doctor..."

So frequently we see or hear this catch phrase either in a four-color pharmaceutical company magazine ad or in a dramatized prime-time television network newcast ad. These ads are of drugs--usually expensive ones--that pharmaceutical sponsors aim toward large numbers of potentially new, frequently older, patients who are not aware of the benefits these drugs can bring to them.

What most viewers, readers, do not realize is that pharmaceutical companies have advertising budgets that usually far exceed even their research and development budgets. So the pharmaceutical company wants to get the biggest "bang" for its advertising dollar. It has found that it cannot do that by straight advertising in medical journals or medical publications, simply because most readers of such journals--doctors--are in the know about these drugs and may not necessarily be in agreement concerning their "merits."

Adertising directly to the consumer through the media, however, has greatly increased the sales of their products, drug companies have found.

An ad on a prime-time network television newscast goes something like this: Frequently a well-known actor appears and states: "I have (XYZ) malady"--the implication is that you, too, may have it, but either you don't know about it or perhaps you're too uninformed (dumb) to know what to do about it. The actor continues: "I use (ABC) product. It gives me the freedom I've long missed. I don't have to restrict my lifestyle anymore. My symptoms have largely disappeared, and I only have to take one pill a day (week, month)." As the actor recites this, he/she is depicted in social situations, showing that the illness no longer is restrictive of normal activities. As the actor beams the benefits of the drug, what is equally recited are the sometimes horrendous side effects of the drug, in some instances dwarfing the medical reasons for the drug. "Yes, this drug for minor bee stings can produce fatal heart attacks, strokes, pneumonia and terrible sore throats, but you'll never be troubled by these pesky insect bites again! Just ask your doctor..."

But these ads do not concern bee stings. They concern abdominal illnesses, headaches, osteoporosis, high blood pressure, heart ailments, stroke prevention and a myriad other conditions that large segments of the population--potential, new customers--worry about.

Most viewers, readers will discount the side effects, thinking if the advertised drug can do for me what it has done for (the character in the ad), I'd like to find out more about it. "Ask your doctor..." is exactly what the patient will do.

The psychodynamics of this situation tip the scale greatly in favor of the pharmaceutical company. Here's how it works.

The patient confronts his/her physician. "You know, doctor, I have these stomach upsets, especially after a spicy meal, and I've seen this ad on television of (ABC) drug that can help. Can I have this drug?" The doctor, perhaps well aware of the patient's condition but reluctant to prescribe the drug for other medical reasons, nevertheless realizes that if he doesn't agree to prescribe it he may well lose a patient. The patient may merely go to another physician until he/she gets the drug.

"Ask your doctor" advertising works because it empowers the patient to ask the doctor directly about a drug it would not occur to the patient to take, were it not for the ad. The doctor would not normally want to incur the risk of losing--or not accommodating--a patient, so the doctor agrees, although perhaps with some reservations, to prescribe the drug.

Drug companies justify these ads by saying they are performing a service--giving information to the public that may be of great benefit to them. What they are actually doing is successfully hooking hundreds, if not thousands, of new customers.

When these ads advise you to "ask your doctor," it is actually like a noose being thrown over your head and being yanked tight. If you follow the drug companies' advice, you may find yourself taking an expensive and unnecessary medication, incurring the risk of serious illnesses as a result of the drug, corrupting the doctor-patient relationship, i.e., your welfare, in favor of pharmaceutical company interests. By agreeing to the pharmaceutical company's recommendation, you will have unwittingly put yourself in the role of a pawn in the fight for your dollar and your medical well-being.

Thursday, July 5, 2007

Compromised medical information

A study hits the medical media--prime time television news, newspapers nationwide, the internet--talking of new advances in medicine: a new drug for cancer, for arthritis, for heart disease, for Alzheimer's. It's been published in the current issue of a presigious medical journal.

But is it true? Is it factual? Is it even honest? These aren't insignificant questions. There are such things in medicine as 'conflicts of interest' and unfortunately they frequently infect our medical studies. Even the ones published in respected medical journals.

Today the cost of clinical studies is generally very high. Hospitals, medical centers--even federal health agencies with large budgets--find it difficult to finance a study. Frequently it is the pharmaceutical industry, or medical equipment manufacturer, that finance a clinical study.

Here's how it works. Drs. Jones and Smith and their associates at XYZ University or Medical Center wish to test a new drug on patients manufactured by ABC Pharmaceuti-
cals. Or ABC Pharmaceuticals seek out Drs. Jones and Smith to test its new drug. If the test turns out positive, ABC will earn a lot of money. ABC therefore underwrites the cost of Jones' and Smith's study.

But, you see, there's a catch. Because ABC pays for the study, it 'owns' it. That means that in order to publish their findings, Jones and Smith must first have the 'approval' of ABC Pharmaceuticals. In other words, ABC has 'first crack' at the study. If there is anything about the study or its outcome that ABC doesn't like--usually concerning side effects or drug efficacy--frequently ABC can choose not to have the study published. Period. The data are suppressed. The public will never learn of the findings or find out what ABC is objecting to. Or ABC can suggest to Jones and Smith that they remove data unfavorable to the drug and then go ahead and publish.

But why would Jones and Smith agree to do that? Because they are "on the take" from the drug company. They actually receive financial remuneration from ABC for doing the study. How about the hospital, the medical center, the research facility in which the study is done? Wouldn't they be equally outraged by ABC's tactics? But frequently enough they, too, are "on the take." Part of the deal of the ABC study is that the medical research institution in which the study is done is itself financially compensated.

This is a "classic" conflict of interest. At first, medical journals required authors to state whether they had financial ties to the company whose drug they were testing. If so, the editors of the journal would either reject the paper for publication or require a statement in the published paper that the authors--and/or medical institutions--were receiving financial compensation. But,in recent years, because this kind of conflict of interest has become so common, many journals no longer reject such papers or require such a statement.

How does this affect you? In 2006 a scandal broke concerning the drug VIOXX. The authors of this pharmaceutically-sponsored drug study published their results in the prestigious New England Journal of Medicine but prior to publication removed data unfavorable to VIOXX which indicated this drug could produce fatal heart attacks in otherwise healthy patients. It is unknown how many patients suffered fatalities or heart-damaging effects, but lawsuits against the pharmaceutical sponsor still persist.

How many VIOXX's are there out there? How many clinical studies are there out there that are not quite what they say they are? How many patients are there out there who are taking drugs in good faith that are not doing them any good or are positively and unrecognizably dangerous--until such time as fatalities or serious side effects break out? We don't know.

Well-known syndicated columnist Paul Krugman suggests that clinical studies and their results are to be considered "suspect" because of the "deep financial links" between doctors, hospitals, research institutions and drug companies.

The basic question here is: How reliable are our published clinical studies? And the media bally-hoo behind them?

Whenever a clinical study is published or publicized without it being known whether the authors of the study or the medical institution in which the study was done were being financially compensated by the sponsoring drug company--whenever this possible conflict of interest is not spelled out in detail--the study must be considered
"phony." Unless proven otherwise.

On the evening network television news, every week there are stories of "ground-breaking" new clinical studies--new drugs or medical advancements. Where are they? Where are the results of these well-publicized and dramatic developments?

Needless to say, today there are a lot of "phony" studies...

Until we have a system in which no doctor, no research institution, no hospital, no medical center can receive incentives from sources that have a proprietary interest in the drug or equipment under test--until we can eliminate the conflicts of interest
that are choking the truthfulness of our clinical studies--they will always be subject to ethical compromise and we will never have an accurate impression of their true clinical value.