Being a graduate student in Biomedical Engineering means that I spend a lot of my time learning about the Federal Drug Administration and how they regulate business. Any time medicine or medical devices are modified, invented or manufactured – everything from pills to artificial hearts to bandaids – the device must pass through a long and tedious FDA approval process. Many people who work in the medical device industry feel that FDA regulations are at times overly stringent and expensive, but considering some of the major devices that have made the market in the past (and caused tragic failures) definitely underlines the importance of medical regulation.
Thalidomide – Given (mostly in Europe) to pregnant women to prevent morning sickness, this drug led to widespread birth defects in thousands of children born from 1957 to 1962. Thankfully, the FDA (which is specific to the United States) blocked commercial sale in the US, citing inadequate test results. Ironically, the drug is believed to originally have been discovered by the Nazis.
Plutonium Pacemaker Batteries – Obviously, the medical community now tries to avoid inserting radioactive material into the body for prolonged periods, however nuclear batteries could in theory last for up to 14,000 years. There are still some in existence today, but they can cause pretty big problems if they get cremated along with the body they are implanted in. Apparently these guys sometimes get hot as crap due to all the radioactivity… Also, the government is paranoid that patients with nuclear batteries could be kidnapped by terrorists trying to get their hands on some dirty bomb material (no joke) and so they are closely watched by the government and their pacemakers are extracted by FBI agents immediately following death, kind of like that guy from Indiana Jones and the Temple of Doom who rips peoples hearts out.
here is your flaming heart that i just pulled out of your chest, bitch
Rely Tampons – In the 1970s there was a super absorbant tampon introduced into the market called Rely. So absorbant, in fact, that Staph bacteria found it a perfect place to set up shop in the body. Bacteria are nothing new to the body, and staph covers almost the entirety of our skin and hair, however the massive absorption of toxins created by such a large community of bacteria in the tampons lead to many cases of Toxic Shock Syndrome, a very serious illness that led to several deaths. Rely was pulled from the market in a huge recall that ended up costing several millions of dollars.
Guidant Ancure Endograft Device – Basically, this was a patch put over arteries in the lower abdomen to prevent their rupture (called an anuerism). However, the company knew that the device had a high rate of failure in many cases but withheld this information from the FDA. Roughly 1/3 of the 18,000 units sold had to have Medical Device Reports filed (if something goes wrong with an individual device, it must be directly reported to the FDA). The president of that company has been in jail since 1993.
Fen-Phen – Wyeth (who strangely has been responsible for a huge number of medical device failures) combined two drugs to make this weight loss pill, however scientists estimate that it caused severe damage to heart valves in as high as 30% of users. The recall and lawsuits cost Wyeth an estimated $18 billion
Vitamin C – This one doesnt really have anything to do with the FDA, but nobody has really proven through blind studies that large amounts of vitamin c taken during illness will help speed recovery or prevent the disease from getting worse. Some studies suggest that vitamin c may slightly help speed recovery, but there is no additional effect after eating the vitamin c found in roughly 2/3 of an orange for an entire day. Did you know, pound for pound, that a lemon has more sugar than a strawberry? Vitamin C will, however, prevent scurvy, the symptoms of which include sunken eyes, pale skin and teeth loss. All of which are also symptoms that you may be pete doherty.
pete doherty or pirate?
Dalkon Shield – A 1970s intrauterine contraceptive. This case really makes you wonder WTFudge is going on with people. In the 1970s, this device was being tested for FDA approval by one of the inventors. Put bluntly, the very person who has power to decide if this device is safe or not stood to make millions of dollars off his own approval, an obvious conflict of interest. Anyways, he ran some tests showing that the device prevented a lot of births, however he did not test the safety of the device. Some of the side effects included infections, infertility, spontaneous abortion, serious birth defects, possible cancer and death of the women users. More than any other, this product has had a serious effect on the medical industry. Once the details of the corruption in testing and selling this device were brought to light, there were some serious changes made to the FDA, including the Medical Devices Amendment which required very strict testing for medical devices (not just medicine, the only standard at the time).
Upton Sinclair - The Jungle
Anyways, I wanted to make some comments about the history of the FDA. Everyone knows about turn of the century medicine including coca-cola which contained actual cocaine, as well as drugs that made ridiculous claims like granting eternal life. The good ole US of A had no real drug or food regulation until Teddy Roosevelt passed the Food and Drugs Act of 1906 a few months following Upton Sinclair’s famous exposure of the corruption in the meat packing industry called The Jungle . Originally companies were only forced to verify the therapeutic claims made on their packaging, but over the years the regulation evolved to include proof of safety and efficacy, proof of ingredients etc. Around the passage of this act, Teddy Roosevelt was perceived by many to be an enemy of business and medicine, forcing many companies who made unproven drugs out of business and costing even the legitimate companies huge amounts of money in regulatory studies. Even worse, politicians jumped on Roosevelt for costing taxpayers large percentages of their paychecks in unnecessary taxes for pointless governmental overhead. Some of the worst opponents of the FDA claimed that Roosevelt was a detriment to the American Public, and I suspect that had it been a popular derogatory term at the time, many would have called him a Socialist, Communist or other such insult.
Teddy Roosevelt - riding rough
Although the 2008 election is probably not fresh in anyones mind, I was really troubled by the way the Obama campaign was slandered for its advocation for Universal Healthcare. First of all, I want to make it clear that while I support the concept of Universal health care, I am not firmly under the impression that Obamas plan is the best. A good discussion of the health care situation and some suggested fixes are discussed in an Economist article here. What really bothers me is that Obama has been called a Socialist for his attempts to institute Universal Health care in the US. I suspect that most people who say this would not be throwing around the S-bomb had McCain and his equally Soviet health care plan were in office right meow. All unabashed salt-in-the-wound-rubbing aside, I believe that in 2109 many Americans will go through their entire lives with their insurance completely paid for by some system of taxes or regulations that ensure that no matter their social status, income bracket or health, they will be treated with the high quality medical standard that we should all be entitled to. Hopefully we can realize that (like all good things) this reform may cost us some money, in the long run government sponsored health care will help prevent unaffordable costs of health on the poor and wealthy alike. Perhaps in 100 years our childrens childrens children will look back on the reforms that our generation had the clearness of vision, the foresight to make bold changes that distinguished our civilization from the primitive foam. While I will not be so bold as to claim that the name Obama may be one held synonymous with Roosevelt, I believe that President Barry’s efforts to purify the health system of our nation will be regarded with as much importance as President Teddy’s creation of the FDA. I realize that the criticisms of Universal health care as socialist are probably fueled in equal share misunderstanding of the concept as well as focused attacks by less than informed news sources with an agenda, but it still seems a painfully myopic, misinformed attack of the Obama campaign. It also pains me that I think this very good cause has been transformed completely into a different, politicalized issue by certain groups looking to create disdain for the Democratic Party. I understand how politics work, but sometimes it is best to put aside partisan bull jive to attack real problems, not to attack causes as a means of attacking each other. Universal health care is the right thing to do. I hope we can be the generation to finally see its enactment.
Rembrandt - The Anatomy Lesson of Dr. Tulp