Columnist ignores complicated, lengthy FDA approval process

To the Daily:

This letter is in response to Sam Singer’s column (How Adderall slipped through the cracks, 03/15/2005). While well written and seemingly thoroughly researched, I think Singer has followed the lead of the mainstream media and blown out of proportion an issue relating to prescription drugs. From the beginning, he suggests that Adderall is an example of how pharmaceutical companies take advantage of the public by stating that Attention Deficit Disorder is “an epidemic of the upper class.” Singer seems to believe that ADD is a made-up disorder for misbehaving or underachieving kids of wealthy parents. Throughout my years of schooling I (like presumably most people our age) knew several people with ADD, and economic standing had little correlation to who was diagnosed. I realize this fact hardly constitutes clinical data, but I did observe Adderall and similar drugs help struggling friends from many backgrounds.

Next, Singer attacks the FDA by basically providing arguments frequently heard the past few months, that the FDA frequently lets dangerous drugs “slip through the cracks” and then tries to cover up its mistakes. He mentions that Adderall has been linked to about 20 deaths in Canada according to Health Canada and criticizes the FDA for not seeing this as evidence that Adderall poses a health threat. However, this is a very small percentage when you consider how much Adderall is prescribed and the many confounding factors that may also be contributing to the deaths. The article goes on to mention the much-repeated reports of adolescent suicide risks linked to Paxil and Zoloft and Vioxx’s links to heart complications and death. Unfortunately, Singer does not present the latest information in either case. Last month, the FDA backed off its statement that there was a causal link between adolescent violent behavior/suicide and Paxil or Zoloft (drugs that the FDA never approved for children and teens anyway). In regards to Vioxx, Singer must not have seen that the FDA voted to allow Vioxx back on the market after pulling it last fall, suggesting the risk is not as great as initially thought.

I do think Singer presented many interesting points and do not in any way think that the FDA or pharmaceutical companies are at all infallible. However, it is tiring to see the same arguments constantly brought forth by the media when there is little evidence used to back them up. People should look up the FDA’s process for approving new drugs and see how complicated the process is that may take several years, rather than just assuming that the FDA is not doing its job because the media said so. I have heard that aspirin would not be approved by the FDA if it were just coming on the market today. Every drug has side effects, and many drugs can kill you if taken improperly. Adderall was not approved to treat college students needing to pull all-nighters during finals week, yet how many of us know students who have gone to UHS and faked symptoms to get a prescription? Drugs are not miracles, and it is not impossible for drugs with dangerous side effects to make it to the market. However, I don’t think it’s the job of the media to discover these health threats.

Mike Deogracias

Alum

The letter writer is a research assistant in the Pathology Department.

 

Drug tests prior to release cannot catch all side effects

To the Daily:

I am writing in response to How Adderall slipped through the cracks (03/15/2005) by Sam Singer which was a comment on the increasing popularity of the “black market” prescription dextroamphetamine, Adderall. I would like to begin by saying that there are obvious drawbacks to the current system of checks and balances the Food and Drug Administration uses to monitor and control marketed prescription drugs. However, I would like to clear up any misunderstandings one may have about how a drug is released to the public.

As our current system works, a candidate drug wishing to make it onto the market will reach no more than 3,000 people before being released to the public, so it is virtually impossible to know how severe the toxicity of the drug is in larger groups of the population. For example, a certain drug may produce an “adverse event” — an undesirable side effect — in a considerable fraction, say 100 cases out of 100,000 people taking the drug. This number is significant when the sample size of the population is so large, but it is only three out of the 3,000 people that will take the drug before it is on the market. The significance might or might not be noticed in clinical trials, but the point is that is much harder to identify until the drug reaches large numbers of people.

So in order to balance this problem, the FDA has a couple different programs in place. One is where doctors and other health professionals report adverse events to drug companies which are then required by law to notify the FDA. The other is a voluntary system called Medwatch, used by consumers and health care professionals to submit their own reports directly to the Office of Drug Safety within the FDA. Experts and scientists then review these reports and try to determine if a drug on the market is causing more harm than good. There are obvious kinks in this system because it is almost impossible to guarantee no one gets hurt by a drug. As it stands now, the FDA has only to determine if a certain drug’s benefits outweigh its risks; it is willing to submit to the fact that a small number of people may be harmed by a drug so long as it is obvious enough that a considerably larger number will benefit from it.

James Michel

RC junior

 

MSA officials clarify election board involvement in campaign

To the Daily:

This letter is in response to Jeremy Davidson’s article (MSA election board questioned over bias, 03/15/2005). In this article, Davidson wrote “(Carl) Pogoncheff said the election board, which is composed of members of (the Michigan Student Assembly), acted with bias during the last election when issuing a punishment for Tim Wiggins, a Students 4 Michigan candidate who was kicked out of campaigning in the dorms by University Housing last semester.” There is a factual mistake in this passage that we would like to clear up.

MSA and the election board did not issue this punishment to Wiggins. The issue was handled and the punishment was delivered solely by the Residence Halls Association. The election board deals with complaints from candidates or parties against other candidates or parties. The complaint against Wiggins was made to RHA and came from students in the residence halls. The election board played no part in hearing this complaint, norhanding down the punishment. Furthermore, there were no complaints registered with the election board in the last election, and consequently no punishments were delivered.

Brian Doughty

Engineering senior

The letter writer is the MSA Election Director.

Russ Garber

LSA junior

The letter writer is the MSA Rules and Elections Committee Chair.

 

Immoral book review should have been censored

To the Daily:

I am writing to bring your attention to the recent book review by Bernie Nguyen (Revamped ‘Kama Sutra’ blows, 03/08/2005).

I was surprised to see an article of this nature printed in the Daily. Not only was this review not suitable for reading, but has nothing to do with the subject of fine arts.

Articles which are explicitly immoral and leave behind the aspects of the Virtuous Life, personal graces, and the conscience need to be censored!

If such vile material were printed 30 years ago, a person would be expelled from college or arrested.

Paul Reimann

The letter writer is a University Hospital employee.

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