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What The FDA Doesn't Want You To Know

by Stephen Propatier

August 22, 2014

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Donate Conspiracy theorists and cranks, such as Mike Adams or Dr. Joseph Mercola, like to say that the Food and Drug Administration is keeping the truth from you. Like all good lies there is a grain of truth to that statement. Experimental research is submitted to the FDA without ever being made public. Overall there has been a push in the US to have more transparency about drug research. This is a thorny issue on many levels. How much transparency is too much, and at what level does full disclosure become a problem? Many laypeople would say that full disclosure is best. Factually that is not always true for a variety of reasons. Scientific American recently published an online article discussing this very issue, called "FDA Debates Secrecy Surrounding Experimental Drugs."

The argument for the release of preliminary data is based on the idea that full transparency will help the FDA and drug companies stay honest. Experimental research is a grey area. Traditionally, data the FDA collects while conducting clinical trials have been considered confidential, along with other business information. However, recent instances of incomplete disclosure of safety data and delayed disclosure of drug risks have raised questions about the necessity of such secrecy and whether the government's regulatory oversight makes sufficient provision for public access to drug-safety data. Greater transparency seems fairly straightforward and beneficial.

It is true that pharmaceutical companies need to be held responsible for their research and their advertising. That doesn't mean that forcing full disclosure of all research is universally beneficial or even helpful. In the case of experimental medication research, revealing preliminary interpretations imposes several scientific and business hurdles. These hurdles could have a negative effect on our understanding of a drug's effectiveness—not just during research but also, possibly, over the long term.

There are very specific reasons for the FDA and drug companies' interest in withholding data. Preliminary evaluations are just that: preliminary. They can easily be misinterpreted. If preliminary data, negative or positive, are presented to the lay public by the media it gives uniformed public opinion and interested spin-doctors too much potential influence on the FDA's decision-making process. It could invalidate blinding. The misinterpretation of harm could result in the stalling or halting of clinical trials based on unfounded concerns. It can drive demand for a treatment that later proves useless or even dangerous. Only a group of experts can evaluate the risks. There is no good reason to disclose all preliminary data on experimental medications to the population at large.

A recent incident showed how preliminary data is misleading. It showed a false benefit to the drug. Alogliptin is an oral drug to treat diabetes and was in trial for safety and efficacy. The journal Nature reported:
Interim analyses of the drug's heart risks were conducted once 81 cardiovascular events had been seen in study participants, says William White, a specialist in preventive cardiology at the University of Connecticut School of Medicine in Farmington, who led the study. Those data showed that the drug did not greatly affect the rate of cardiovascular events, White says, but could have been misinterpreted to suggest that the drug actually lowered the risk.
The manufacturer could have immediately manipulated this result into an assertion that diabetics need their new, expensive drug because it lowers patients' risk of heart disease. Full disclosure of such data, making an appeal to the public rather than experts, could have resulted in a misleading but persuasive claim for the drug's efficacy. Again, drugs need to be properly vetted. When preliminary data colors perception of a drug there are two equally problematic issues: the drug can be inaccurately perceived as dangerous or the drug can be perceived inaccurately as beneficial.

As well, disclosure of preliminary data may affect our ability to do the actual study itself. Potential subjects may refuse to participate in a study or they may demand rapid approval without a thorough analysis of risks and benefits. Both are unfavorable barriers to developing safe and effective treatments. If preliminary data are released willy-nilly then pharmaceutical corporations would quick to promote their still-experimental therapies as beneficial without proper proof.

The lay public has an exaggerated opinion of what a single line of evidence means. News media outlets, looking to attract eyes, ears, and clicks, are even worse about sussing out the usefulness of unfounded conclusions. Like all good science, drug development requires multiple lines of data to produce good answers.

All drugs and treatments carry risks. What is critical to developing a safe drug is an evaluation of both the risks and the benefits. Experimental drugs, by definition, are relative unknowns. There are risks, and finding those risks requires developing solid evidence. The only way to truly discover actual risk is to study human participants in well-constructed trials. The risks are evaluated in careful progressive stages; first under animal/in-vitro studies, then in studies under ethical oversight by and institutional review board. Yes, by participating in an experimental drug trial patients and subjects are taking risks that may not be fully understood or known. There is no good way around this. Animal modeling, and even computer modeling, can be helpful but they don't provide the kind of confidence we want before a drug goes to market. Human beings are extremely complex organisms and no matter how much caution is taken there are unknown and unexpected outcomes.

There is no doubt that there has been corporate malfeasance involving drug research data. The FDA, despite its complicated approval process, has sometimes failed to catch them. Disclosing all experimental data is not a good tactic to deal with this problem. The lay public lacks the necessary medical knowledge to truly understand the risks and benefits of prescription drugs, and it can have the vocal power to negatively interfere with good science. It takes years of specialized pharmaceutical education, training, and experience to be able to develop drugs and understand their effects, even just to understand how to read a study on them. It is a complicated specialty. Drug data, like all science data, should not be subject to public opinion or corporate spin.

It is shortsighted to think that full disclosure could be a panacea to the problems in the US drug-approval process. There are better, more achievable ways to limit malfeasance in the pharmaceutical industry. Corporations should have to publish all research done on drugs, whether it goes to market or not. But this should be done after the approval process has run its course, not before or during.

Perhaps more importantly, providing the FDA with greater resources for oversight and accountability would help ensure its effectiveness in its mission to safeguard consumers. The FDA suffers from a lack of manpower and money. This situation is encouraged by the pharmaceutical and supplements industries—corporations that have a vested interest in suppressing criticism of their products. Political pressures from industry and special interest groups have slowly eroded the FDA's ability to protect us. The FDA needs bigger, better teeth to deal with these problems, to be able to regulate without choking off investment in drug research.

Research into new drugs is fantastically expensive most of the research is funded from private industry. Privately funded drug research is profit-based—not a perfect system. Sales of proprietary, brand name drugs fund a great deal of new drug development; sales of Lipitor help subsidize the research for less profitable drugs like antibiotics. Without that money new drug development would grind to halt. This is important for the world, not just the US. Most countries regulate the cost of medicines and exclude the cost of research. The US almost exclusively finances the cost of new drug research by paying uncontrolled prices for drugs. We also are also bled for the highest profits. We need to enhance and strengthen the transparency process without obviating the financial incentives that drive new research. This has traditionally been a difficult tightrope to walk. Most companies will not fund billion-dollar investments into new drugs if all their information becomes public knowledge. Yet they have proven that they cannot be trusted to be forthright with complications. It is not getting any easier.

Nonetheless, forcing the FDA and industry to release shaky preliminary reports is a poorly thought out and superficial answer to the problems of the drug industry. It is a prescription for more problems.


-The Alogliptin Study

-"Who Pays the Most for Pills" shows average drug prices in various countries, with the lowest average equal to 100. (Source: U.S. Senate Special Committee on Aging) (pg. D1)

-"Comparing the Costs, at Home and Abroad" shows average prices for common brand name drugs in the United States and other countries. (Source: U.S. Senate Select Committee on Aging) (pg. D3)

by Stephen Propatier

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