Hiding Data: Big Pharma’s Dirty Secret

When you take medication to lower your blood pressure, fight an infection or help stabilize your blood sugar, there are some important facts you should consider. The research that went into developing those medications could be inadequate, spun, suppressed or outright falsified. Hiding data is one of Big Pharma’s dirty secrets that could be affecting your health.

Early Warnings

As early as 2005, Dr. John Ionnadis raised the concern that “most current published research findings are false.” Ionnadis mentioned study bias in particular as a problem and noted that other possible issues were related to the size and design of studies. He also singled out the issue of the financial interests of those who fund or conduct the studies (Ionnadis calls them “highly prejudiced stakeholders”) and concluded “claimed research findings may often be simply accurate measures of the prevailing bias.” Dr. Ionnadis is a physician, epidemiologist, statistician and researcher at Stanford University, so he can be presumed to know something about the subject. Yet Dr. Ionnadis didn’t even address one of the biggest problems – hiding data.

Ignoring Risk

One year prior to Dr. Ionnadis’ article, drug manufacturer Merck had withdrawn rofecoxib (brand name Vioxx) from the market because it doubled the risk of myocardial infarction and stroke. Vioxx was used to treat musculoskeletal pain and had been in used for about five years. Despite evidence as early as 2001 that Vioxx increased heart attack risk, Merck continued to market the drug and conducted additional studies on the use of Vioxx for Alzheimer’s disease and precancerous colon polyps. In fact, one of the studies that Merck commissioned on Vioxx confirmed the data about heart attack risk and Merck dismissed the findings. In 2009, Scott S. Reuben, who had been the lead author on 21 studies on the drug’s effectiveness, revealed that his study results were fabricated.

In 2006, the US Food and Drug Administration issued a warning about aprotinin (brand name Trasylol). The medication, used to control bleeding in patients who underwent cardiac surgery, had been found to cause renal failure, heart failure and stroke. An independent study had proved these negative effects, which was why the FDA issued its warning. The headline information, however, was not the FD warning, but the fact that manufacturer Bayer had conducted a private study that reached the same conclusions about the drug’s dangerous effects. Bayer did not, however, report those findings to the FDA.

Data Suppression

Pharmaceutical companies have a number of ways of influencing or suppressing drug research. One is to only perform studies on effectiveness and to not perform any study that might find negative effects. Bayer used that technique for a cholesterol-lowering medication called cerivastatin – brand name Baycol; details came to light in an email from a Bayer executive. Another is to publish only the results that support the drug’s effectiveness. Still another technique is to skew the data through manipulating the presentation. Saying, for example, that 30 percent of the patients showed improvement sounds pretty significant – until you find out the study only included 18 people. Or you simply don’t publish – as many as half of all studies are not published in a given year. Another option is to stop a study early when it begins to show dangerous side effects from the drug (since the study is never published, no one else knows about the problem).

By far he most common way of influencing research is to spend money. Pharmaceutical companies perform their own research, conducted by scientists paid by the company. However, they also support clinical trials – to the tune of millions if not billions of dollars each year – that are supposedly conducted by independent researchers. In addition to supporting the trial itself, the drug company pays the researchers in the form of stock options and/or speaking or advisory fees. Now, when a drug trial is paid for by someone with a vested interest and the researchers performing the study are paid by the same source, what kind of findings would you expect to see?

The Whys of Hiding Data

Why does this data suppression happen? First, it costs a great deal of money and time to develop new drugs. It’s not until the drug is close to being marketable that large clinical studies on effectiveness and safety begin. Negative data at that point can mean the drug manufacturer loses all of its R&D money as well as what is sometimes a huge potential market. Second, it’s a loss of face for the company. Third, the drug industry is extremely competitive. Losing a potential lucrative product can mean losing industry market share, sometimes permanently. For the researchers, producing favorable data means they and their organizations are more likely to be able to get grants and other funding, if not direct payments to individuals. Educational institutions and medical schools that perform the research trials garner prestige, which encourages donors and more grants.

No Solutions in Sight

Sadly, a solution doesn’t seem too likely at this point. Industry watchdogs may not have access to suppressed data; they may not know when data has been falsified. The FDA is slow to move and may be influenced by those it’s supposed to regulate. The average layperson doesn’t know enough and the doctors – who should know enough – may only have access to published data or may have to wade through mountains of information to find out what’s really going on. Those doctors and scientists who do question the situation may be viciously attacked by big pharma and its devotees.

Bottom line: exercise caution when taking any medication. Ask about side effects; don’t assume that your doctor or the pharmacist will warn you of everything that might happen. Pay close attention to your symptoms before and after you begin a medication. If you think you are having side effects, notify your doctor promptly. You can report a possible adverse effect from a drug to the FDA ‘s online MedWatch website. The life you save may be your own.