Yet Another Prescription Drug Proves Useless, Potentially Dangerous
A study has shown that Zetia, one of the most widely prescribed cholesterol reducing drugs, does nothing to prevent heart attacks and strokes, and that in some cases it may make them even more likely, as it sometimes causes fatty plaque to develop more quickly in arteries. 
This should be shocking news, and it is. But its not that unusual of a discovery. The past ten or fifteen years have seen drugs that have been heavily prescribed to millions of Americans turn out to be flawed, useless and potentially life threatening. Remember Vioxx?
The website DrugRecalls.com lists over a dozen prescription medicines that have been either recalled or deemed worthy of serious warnings, including:
- Avandia
- Ephedra
- Crestor
- Fen Phen
- Zelnorm
- Baycol
- Meridia
- Neurontin
- Prempro
- Celebrex
- Risperdal
- Pemoline
- Rezulin
- Vioxx
- Bextra
- Many Antidepressants
All of these drugs have been at one time, or still are being, ingested by Americans all across the country. Why, if they are so potentially dangerous, did they ever make it to the market in the first place?
While there is a growing amount of concern over the practices within the FDA (Food and Drug Administration), the government body that tests and approves or denies new drugs, it is my opinion that there are two serious problems that lead to the approval of dangerous drugs, and one of them may already be rectified.
First, the FDA has had a serious problem in the past. Members of the panels who give recommendations for, or against, the drug in question, have actually in many cases been receiving financial backing from the pharmaceutical companies that have developed the drug in the first place. Can there be a more egregious conflict of interest? An FDA employed researcher being paid, in any way, by the pharmaceutical industry should not, under any conceivable circumstances, be involved int he approval of a drug. In one case, probably the worst, every single member of the trial study panel had been paid by the company that manufactured and developed the drug. This is completely unacceptable. Even if they really do evaluate the merits of the drug objectively, the entire study will smell rotten. We are talking about the health of millions of American who are shelling out unreasonable portions of their income to be able to take these drugs. There should be absolutely zero chance that the integrity of trial study is betrayed because of a researcher or researchers’ nepotism and greed.
However, that said, this problem may already be solved. In March of last year, the FDA released new guidelines that would create more strict rules barring individuals who have financial conflicts of interest from participating in advisory committees. The press release announcing these changes said the following:
FDA would tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.Financial interest means the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government’s action on a particular topic. Financial interests screened include, but are not limited to, stock ownership, related research and consulting arrangements.
Now, while this is definitely a move in the right direction, I do have a problem. $49,000 is a lot of money to most people. Under these new rules, a researcher with $49,999 dollars worth of “financial interest” in the approval of a new drug would still be allowed to take part in the committee’s, even though they cannot participate in the final vote. This set up still has a distinctly rotten smell. Imagine a situation like this:
- Researcher A participates on the advisory committee of one drug, but because he has a conflict of interest, he cannot participate in the vote.
- Researcher B does not have financial interest, and therefore is a full, voting member of the committee.
- In another unrelated study, A does not have financial interest (and therefore can vote), but B has more than $50,000 worth of interest, and therefore cannot participate at all.
Maybe I am being pessimistic about the character or dedication to science of members of the FDA, but it seems to me that in this situation it would be profitable for both researchers A and B to help each other get the drugs in question approved for the public. I’m not even saying that committee members in a situation such as this would make an explicit, spoken deal with each other. What I am suggesting, however, is that, say, researcher B might skew the numbers or omit certain data, having a feeling that researcher A will be grateful and do the same for him.
I think that in order to really prevent corrupt influence on the trials of drugs, the FDA should use only doctors and researchers that do not have any financial interests in the marketing of any drugs at all. However, I’m not sure how feasible this is or how many doctors are even available that do not have these conflicts (anyone that has more information on this should post a comment).
The second problem is that the FDA itself has a conflict of interest once drugs are released to the public. Since they are the institutional that both approves the drugs in the first place, and also the ones that monitor their effectiveness or potential problems amongst the public, that have serious incentive to overlook early signs of danger once the drugs have hit the market. If a prescription that they approved turns out to be problematic or even life threatening to those taking it, it reflects very poorly on the FDA.
The drug Troglitazone, which was used to treat diabetes, was not pulled from US markets for three full years after it had been in the UK. This most definitely resulted in the injury or death of thousands of Americans (David Graham’s congressional testimony can be found here). The FDA was slow to react for fear of backlash.
The only useful solution to this very serious problem is to create an independent agency to follow a drug’s effect on the public after it has already been released. This group should have nothing to do with FDA so that if there is any sign that a drug should be recalled from the market, it can be done quickly and without concern over the FDA’s image. Many would resist the formation of an agency like this, especially proponents of small government at any cost. But in this case, I think it is vitally important.
Of course, there are other, even more insidious problems with the marketing of prescription drugs to the public. In 2004, the pharmaceutical industry spent more than 4 billion dollars for drug advertising. In addition to making drugs vastly more expensive for the patient, all this advertising has created a nation of hypochondriacs that are constantly self diagnosing themselves and then begging their doctors for the prescriptions they think that they need. But in many cases, they do not need them, and studies have found that most television ads don’t fully explain the risks associated with the drugs they are promoting. If you are going to convince people that they need a drug which they most likely do not, at least be completely honest and don’t mislead them as to the potential side effects. There are many groups that are speaking up and attempting to get prescription television ads banned entirely. If cigarettes can’t be advertised on television, and liquor is excluded from many times slots, why not limit or ban the marketing of often-dangerous drugs? This study nicely breaks down the misleading nature of prescription commercials. The following is a portion of the study’s abstract:
Most ads (82%) made some factual claims and made rational arguments (86%) for product use, but few described condition causes (26%), risk factors (26%), or prevalence (25%). Emotional appeals were almost universal (95%). No ads mentioned lifestyle change as an alternative to products, though some (19%) portrayed it as an adjunct to medication. Some ads (18%) portrayed lifestyle changes as insufficient for controlling a condition. The ads often framed medication use in terms of losing (58%) and regaining control (85%) over some aspect of life and as engendering social approval (78%). Products were frequently (58%) portrayed as a medical breakthrough. CONCLUSIONS Despite claims that ads serve an educational purpose, they provide limited information about the causes of a disease or who may be at risk; they show characters that have lost control over their social, emotional, or physical lives without the medication; and they minimize the value of health promotion through lifestyle changes. The ads have limited educational value and may oversell the benefits of drugs in ways that might conflict with promoting population health.
I’ve had the television on next to my desk as I work on this post. While I’ve written, I’ve been shown a total of 17 prescription commercials (note: some are the same ones repeated). I think I should go to the doctor now: I’m pretty sure that I have restless leg syndrome, anxiety, depression, high cholesterol and an enlarged prostate.










The New York Times ran a story
Former U.S. Surgeon General Richard Carmona, along with former Surgeons General C. Everett Koop and David Satcher, testified