Tag Archives: big pharma

A prostate story

Who benefits from testing to see if you have prostate cancer?

Being told “You’ve got cancer” can strike fear into a person’s heart. For middle-aged men, prostate cancer is the most common reason to hear this diagnosis.


Here’s how it usually happens. You have a simple blood test and receive a figure for your PSA, the prostate specific antigen. Anything above 4.0 is supposed to be a cause for worry, and possibly more tests. The number gives the PSA blood level in nanograms per millilitre.

I remember having the test done quite some years ago. A nurse rang to give me the results. She said “It’s 4.1”. I thought, this seems a bit high given my lifestyle. Then she said, “Oh, sorry, it’s actually 0.1”. That was okay, then. Little did I know.

An elevated PSA level is considered a cause for worry. The doctor might recommend a biopsy just to be sure, or the patient might want to know. This can lead to trouble. If the biopsy is positive for cancer, what next?


In the US, most urologists recommend removal of the prostate, an operation called a prostatectomy. This is supposed to get rid of the cancer. It sounds straightforward, but the operation is extremely delicate. The prostate straddles the urethra, the channel for urine and semen, and is surrounded by many sensitive nerves.

Sometimes the operation doesn’t get rid of the cancer. And quite often the operation has serious side effects: most men are left impotent and many become incontinent.

Instead of removing the prostate, another option is called “active surveillance” or “watchful waiting”, though it might better be called “worried waiting”. What this means is checking at regular intervals to see whether the PSA score is increasing.

Although most men in their 50s and 60s have cancer in their prostates, relatively few of them die of it. The cancer is usually slow-growing, so slow-growing that something else kills them first. They die with prostate cancer, not from prostate cancer.

Because the advantages of taking a PSA test are so limited, and the possible side-effects of unnecessary treatment are so severe, some researchers and policy-makers have argued that healthy men should not be screened using the test. On the other side are those – including urologists and advocacy groups, among others – who argue that PSA testing saves lives, and accuse the no-screening advocates of playing with men’s lives.

This debate has played out differently in different countries. In Britain, watchful waiting is more common; in the US, testing and aggressive treatment, especially removing the prostate if there is any sign of cancer, is standard.

Into this debate, there’s a new book titled The Great Prostate Hoax. The subtitle indicates the message: How Big Medicine Hijacked the PSA Test and Caused a Public Health Disaster.


The author is Richard J. Ablin, assisted by Ronald Piana. Ablin has credibility in this area: he discovered PSA in 1970. And he is appalled at the widespread use of the PSA test in the US. He says that as the discoverer of PSA,

I have been linked to the 30 million American men … who undergo routine PSA screening for prostate cancer. The result: a million needle biopsies per year, leading to more than 100,000 radical prostatectomies, most of which are unnecessary. (p. 4, emphasis in the original)

Richard J. Ablin

Ablin provides one key point that undermines the argument for testing: the PSA test is not a test for prostate cancer. It is only a test for the prostate specific antigen, in extremely tiny amounts in the blood. This is not the same as a prostate-cancer specific antigen. Ablin says that using the PSA test is roughly as accurate as flipping a coin. Furthermore, the level of 4.0 as a warning of whether there might be cancer is arbitrary: it was more or less picked out of the air.

Researchers have been searching for a prostate-cancer indicator, but haven’t found one yet. The next question is how the PSA test ever became accepted, given its dubious diagnostic value.

This is where “big medicine” comes in. The PSA test does have some value. For men being treated for prostate cancer, the PSA level is an indicator of whether the cancer has returned, and therefore of how effective treatment is.

For a company selling a PSA test, there’s not much money to be made in testing men being treated for prostate cancer. But there are big bucks in screening. In the US, this means tens of millions of men per year.

Ablin tells the story of how the US Food and Drug Administration (FDA), which licenses medical tests, was swayed by emotion over rationality in approving a PSA test. For example, one of the test’s advocates, Jim Wise, used this approach:

Queried on the suffering of countless numbers of men harmed by PSA false positives, Wise circled the wagons around his insular community – men who claim they were saved by PSA screening – in essence, seemingly implying that their lives outweigh the harms to other men produced by false-positive PSA results. This is the common emotion-based type of exchange used by advocates to promote PSA screening. It’s a kind of flag-waving patriotism that people are loath to challenge; we’ve seen the results of that sheeplike mentality. (pp. 66-67)

But there is more to the FDA story than emotional pleas. Corporate interests played a role. Some FDA advisory committee members tried to expose the scientific shortcomings of the PSA test, but corporate connections prevailed. Ablin describes the FDA advisory committee meeting in considerable detail, down to individual exchanges, revealing a system that is corrupt at several levels.


FDA officials tried to cover themselves by issuing warnings about inappropriate use of the test, but their inaction sent a different message. The FDA did nothing about massive off-label promotion of the PSA test.

Advocacy groups were part of the promotion of PSA screening; many of them are sponsored by the companies. Before long, PSA screening became the basis for a massive commercial enterprise. Screening is only the beginning. False positives keep the money rolling in. Men are told their PSA might indicate prostate cancer and should have a biopsy. Then, quite commonly, cancer is detected in the prostate, and prostatectomy is recommended.

An experienced surgeon can usually do a good job, but many men opt for a much more expensive method using a robot. The surgeon is still involved, but using a complicated piece of equipment. Robotic prostatectomies have become the primary method used in the US, even though there is little evidence they are any more successful than conventional surgeries.

If radiation is the preferred option, the latest generation of high-tech treatment is proton-beam therapy, in centres costing over $100 million to construct. Without sufficient patients, these centres would go bankrupt.

Then there are the side effects of treatment, though they might be better described as the main effects: impotence and incontinence. Ablin offers some moving stories from men whose lives have been seriously damaged by prostate removal. Some of them feel their manhood has been lost.

and so does a prostatectomy

Because of impotence and incontinence, there’s an additional market in medical fixes, for example penile implants and bulbourethral sling surgery. Ablin quotes experts saying that half of urology practices in the US would go out of business if not for the steady stream of patients whose problems begin with PSA testing.

From Ablin’s perspective, PSA testing is a gravy train for urologists and for drug and medical device manufacturers, with a seemingly inexhaustible stream of men entering the shadow of a prostate cancer diagnosis. Ablin calls PSA testing a hoax because there is no good evidence that it reduces the death rate and there is ample evidence that it causes a huge amount of suffering.

The Great Prostate Hoax is powerful testimony to the dangers of a profit-driven health system. It can be added to the growing body of writing about corruption in corporate healthcare, something that causes far more suffering and death than most of the hazards that exercise the public mind.

The book does have some limitations. It deals almost exclusively with the situation in the US, giving little attention to practices and debates in other countries. The US situation is important, to be sure, but insight into ways to control the PSA-testing juggernaut could be obtained by an examination of what is happening in countries where different attitudes and policies prevail. (For an Australian critical commentary on PSA testing, see Let Sleeping Dogs Lie?)

Another context for the book is screening for other conditions. A decade ago, H. Gilbert Welch wrote Should I Be Tested for Cancer? Maybe Not and Here’s Why, providing close scrutiny of the hazards of screening people with no symptoms. More recently, he and two colleagues extended their critique of screening to a wide variety of conditions, in a 2011 book titled Overdiagnosed: Making People Sick in the Pursuit of Health.

The implication of Ablin’s book is that any man without symptoms should be reluctant to enter the screening roller coaster. But is there anything else worth doing? Ablin doesn’t mention non-standard treatments of prostate cancer, for example hyperthermia, available in Germany. Nor does he mention the possibility of nutritional prevention. There is a considerable body of information about the possible benefits of selenium, zinc, fish oil, natural vitamin E and saw palmetto, as well as more general benefits from a diet with cruciferous vegetables. Hyperthermia and nutritional prevention are controversial, to be sure, but their hazards are far lower than conventional treatment.

For men concerned about their personal risks from prostate cancer, it is worth considering a range of information, about prevention, screening and treatment methods. In this, The Great Prostate Hoax is essential reading, especially to appreciate the intersection between science and politics. Ablin deserves the last word.

Medical industry profiteers have squandered trillions of health care dollars since the PSA test was first brought to the market. Given the utter failure of PSA screening, scientifically and clinically, why are we continuing to drain our health care system by repeating something we already know does not work. The late Albert Einstein defined insanity as doing the same thing over and over again and expecting different results. Repeating the same mistakes borne at the beginning of the PSA saga borders on criminal insanity. (p. 228, emphasis in the original)

Brian Martin

Pharmacrime and what to do about it

Is the pharmaceutical industry more dangerous than the mafia? Peter Gøtzsche thinks so.

PeterGotzschePeter Gøtzsche

Did you know that the third leading cause of death in western countries, after heart disease and cancer, is adverse reactions to prescription drugs? Did you know that large pharmaceutical companies usually control the trials of their new drugs, and sometimes manipulate the published results by misclassifying deaths, excluding some participants and not revealing studies that came up with null results? Did you know that some of people listed as authors of drug studies published in leading medical journals have had little or nothing to do with the research, have not written the papers, and are paid for their symbolic role? Did you know that several major pharmaceutical companies have paid fines of over one billion dollars for corrupt practice? Did you know that government drug regulators in several countries have become tools of the companies they are supposed to regulate? Did you know that hundreds of thousands of people have died from drugs when the company executives knew about and hid information about the hazards?

This information has been known to critics of large pharmaceutical companies — commonly called big pharma — for many years. There have been powerful critiques written by former editors of medical journals and as well as exposés by whistleblowers. Now there is a new book that puts together the case against big pharma in a more comprehensive and hard-hitting way than ever before: Peter C Gøtzsche’s Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare (London: Radcliffe, 2013).


The bulk of the book is a critical examination of research findings concerning pharmaceutical drugs, serving to illustrate general points. For example, chapter 4 is titled “Very few patients benefit from the drugs they take,” seemingly a startling claim. Gøtzsche gives some hypothetical examples of how results of drug testing might sound encouraging but actually disguise a very modest effect, and how double-blind trials that are not properly blinded can give misleading results. He then cites studies of antidepressants to show that the actual situation is probably worse than his hypothetical examples.

Different chapters in the book deal with conflicts of interest, pharmaceutical company payments to physicians, drug marketing operations, ghostwriting of articles for medical journals and the inadequacy of drug regulators, among other topics. Each of these chapters includes case studies of particular drugs or company operations. Then come chapters about particular drugs, abuses and companies, for example chapter 14 on “Fraudulent celecoxib trial and other lies.” Gøtzsche exposes corrupt practices, including the hiding of trials that did not show a benefit, disguising adverse drug reactions, promoting a new highly expensive drug that is no better than an existing one, making false statements about the benefits and risks of drugs, applying pressure on drug regulators, and suppressing information about dangerous drugs on the market.

Gøtzsche relies heavily on published studies (including his own) to back up his claims: the book is thoroughly referenced, with numerous citations to articles in medical journals. Deadly Medicines and Organised Crime is in the tradition of rigorous and knowledgeable exposé. Some previous books along the same line include Marcia Angell’s The Truth about the Drug Companies and Jerome Kassirer’s On the Take. Angell and Kassirer had been editors of the prestigious New England Journal of Medicine.

Gøtzsche has impeccable credentials to write a critique of big pharma. He started his career working for a drug company, and saw dubious operations from the inside. He qualified as a doctor and then worked as a medical researcher for many years. Most importantly, he is a key figure in the Cochrane Collaboration, a group of medical researchers who scrutinise the full complement of studies of particular drugs, drawing conclusions about benefits and risks.

Undertaking a meta-analysis of drug trials seems like an obvious thing to do. What makes the Cochrane Collaboration significant is that it is largely independent of the drug industry. The industry’s influence is so pervasive that many trials are fraudulent or misrepresented, many publications are ghostwritten by company staff, and evaluations by drug regulators are biased due to company pressure. Being relatively independent of this influence makes an enormous difference.

As well as obtaining insights from his involvement with the Cochrane Collaboration, Gøtzsche has had personal involvement in trying to influence drug policy. Being from Denmark, on various occasions he has provided information to the Danish drug regulator on crucial issues, such as that a new drug is far more expensive than an existing one, but no more effective. Yet the regulator on many occasions has served drug company agendas by approving drugs, costing the government large sums of money and providing no added benefit to patients.

Here is Gøtzsche’s summary of problems with drug regulation.

We don’t have safe drugs. The drug industry more or less controls itself; our politicians have weakened the regulatory demands over the years, as they think more about money than patient safety; there are conflicts of interest at drug agencies; the system builds on trust although we know the industry lies to us; and when problems arise, the agencies use fake fixes although they know they won’t work. (p. 107)

In describing the unethical and damaging activities of the drug industry, with case after case of egregious behaviour, Gøtzsche sometimes expresses his exasperation. This comes across most strongly in the chapters on psychiatric drugs, many of which are useless or worse, cause addiction and massive damage, yet are widely prescribed due to massive marketing.

Gøtzsche’s book is filled with information and thoroughly referenced, yet perhaps its most striking feature is his claim that big pharma is organised crime, as indicated in the title. At first this may sound exaggerated, or just a metaphor, but Gøtzsche is quite serious. He looks at definitions of organised crime and finds that big pharma fits in all respects: the companies knowingly undertake illegal actions that bring them huge profits and kill people, and they persist in the same behaviour even after having been convicted of criminal activity.

At many points, Gøtzsche asks rhetorically what is the difference between the activities of big pharma in promoting addictive and destructive drugs and the activities of drug cartels producing and selling heroin.


Calling big pharma organised crime is in a tradition of pointing to double standards in the way behaviour is labelled. The term “terrorism” is usually applied to violent acts by small non-state groups; some scholars have pointed out that many governments use violence to intimidate populations in way that fits the usual definitions of terrorism. They call this “state terrorism.”

If the operations of big pharma are a type of organised crime, except killing many more people than the mafia, what is to be done? Gøtzsche has a chapter spelling out ways to bring drug testing and regulation under control. One important step is for all drug testing to be done by independent scientists, rather than by the companies that manufacture the drugs. Another is to disallow payments from drug companies to physicians, researchers, medical journals, and regulators. Gøtzsche draws an analogy: what would people think if judges received payments from prosecutors or defendants? It would be seen as corrupt, of course. Company payments to physicians, journals and regulators should be seen as corrupt too.


Gøtzsche’s recommendations are sensible and, if implemented, would transform the way drugs are used in society. If this happened, company profits would plummet, which means that companies will do everything possible to maintain the current system. As well as saying what should be done, there is a need for a strategy for bringing about change, and the strategy has to involve citizen campaigners as well as concerned researchers and physicians. Just as the movement against smoking has involved a wide range of campaigners and methods of action, so too must a movement against corruption in healthcare. Deadly Medicines and Organised Crime is not a practical manual for such a movement, but it is essential reading for movement activists, especially so they will know what they are up against.

For readers thinking about their own health, and the health of their friends and family members, Gøtzsche provides important messages. He suggests not taking any drug unless it is absolutely necessary, because benefits are minimal and there are always potential harms. In this category would be included antidepressants and drugs to lower cholesterol and high blood pressure, for example. If you’re going to take a drug, then it’s usually better to take an old one, because newer ones are probably no better, cost vastly more, and are less well tested for harms.


If you want to know more about the drugs you take, seek independent advice. That’s not easy, because so many researchers, medical journals, physicians and regulators are in the pay of the industry. Reviews by members of the Cochrane Collaboration are a good place to start. So is Deadly Medicines and Organised Crime. Gøtzsche provides enough references for even the most assiduous reader.

Brian Martin


I thank Melissa Raven for useful comments on a draft of this comment.