Why the FDA approves bad drugs

by Daryl Kulak (Subscribe to Daryl Kulak's posts)
Oct 4th 2006 1:00PM

Categories: Celebs & Entertainment, Reviews & Products

The Week magazine ran a controversial article entitled "The Corruption of Medicine" last week.

Cases of biased research of pharmaceutical drugs are rampant and getting worse. These are not small offenses, but problems that have caused many patients their lives.

By now, the case of Vioxx is well known. This drug, created to ease the pain of osteoarthritis and other illnesses was rushed to market using FDA data based on studies done by Merck's own employees. Later, we found out that Merck had information before the approval process that Vioxx did cause heart-attack deaths, but they hid it from the FDA. The drug was eventually withdrawn, after causing over 88,000 heart attacks in patients, with an estimate of at least 26,000 deaths.

But the article contains many more surprises.Rezulin was marketed as a diabetes drug in the 1990s, but it was linked to 90 cases of liver failure and 63 deaths. The FDA knew of the problems since 1997 but allowed the drug to remain available until 2000. The FDA cited a favorable study in the New England Journal of Medicine as reason to keep it on the market. However, 12 of the 22 researchers involved with the study had financial ties to Warner-Lambert, Rezulin's maker.

Surprisingly, researchers caught "red handed" are often quite brazen about their indiscretions. Dr. Charles Nemeroff, a renowned psychiatrist at Emory University, promoted a product of his own invention in a journal article in Nature Neuroscience without disclosing his financial interests. When confronted, he said he was certain the results would have been the same even if he had no financial ties to the product.

Somehow, these scientists see themselves as "absolutely objective," as if they are beyond any human failings.

In another instance, Dr. Irwin Goldstein of Boston University collected consulting fees from drug companies while doing medical research. "Science is science," was his excuse. "What the data shows, the data shows."

So who loses in all of this?

You and me.

We really can't trust the research being done on pharmaceutical drugs. Or, as the deputy editor of the Journal of American Medical Association (JAMA) says "Doctors don't know what papers they can trust in the journals, and the public doesn't know what to believe."

Source

Comments (8)

Reader Comments (Page 1 of 1)

Becky 10-04-2006 @ 9:33PM

There's risks with EVERY medicine on the market. It's up to our doctor's to decide that the benefits outweigh the risks when prescribing medication.

Especially true for recently approved drugs. There just isn't enough known and enough patient history to know what the long term effects of these drugs are.

Daryl Kulak 10-05-2006 @ 9:55AM

Becky,

To me, the "risks to every medicine" is an excuse.

In one corner, we have Vioxx, proven to cause 88,000 heart attacks. In the other corner, we have acupuncture for pain relief, proven to cause...what? A sore finger?

To say there are risks with everything, and that makes it okay to jump to an incredibly risky drug as a first line of defense, that just seems wrong. We owe it to ourselves to be educated about what the safest, cheapest, effective remedies are, and choose those first.

I also strongly agree with the statement that "it's up to our doctors..." I have no intention of putting my health in the hands of a doctor. I want to know everything that is going on, what the safety of the medications are, and why each procedure is being done. I want to be in charge of my own health, not hand it over to any "expert."

Since my first line of defense is often nutrition or exercise, this makes me especially unlikely to consult a doctor, since they often receive just a few hours of nutrition and exercise training in their years of medical school. I'd much rather talk to a nutritionist or naturopathic physician first, and if they refer me to a Western medical doctor, great.

And finally, what you said about the newly approved drugs is exactly right. That is why I would steer clear of them whenever possible. My choice would be the oldest remedy available - Traditional Chinese Medicine, Indian Ayurveda, massage - all thousands of years old.

Thanks for your comments, Becky!

D 10-05-2006 @ 9:54AM

Acutally, Becky is quite right. There are risks to every medicine and sometimes these are not known until the drug is on the market and a larger population has used it. This helps ferret out lesser known (or yet unknown) side effects and prevalence/importance of existing sdie effects. Accupuncture? I would be concerned about infection more than anything else! Consumers/patients shoud be knowledgable about what they are taking. Pharmacists can be a great help here- as long as they aren't tied up figuring out the insurance coverage all day....
Diet and exercise are very important.. but there is much more proven science in pharmaceuticals than most natural remedies- especially for example herbals- since they are highly variable and one rarely knows what is really in what they are taking. Even though there are labels- it is a completely unregulated industry which is not good for consumers. Even with ingredients and % on the labels, sometimes in natural medicine it is one part of the plant and not the whole plant, that is important so this is highly variable. Being old is not necessarily better...
Pharmaceutical companies and researchers have to have oversight just like anything else....

JJ 10-05-2006 @ 9:57AM

There are risks, but reasearch HAS been compromised ever since it became privatised. Like the recent study that showed women in France are getting fatter. How can you trust that information when the research was funded by a diet pill company?! You're a bleeding idiot if you believe it. The FDA allows bullsh.. research to be accepted, knowing it's false information, cos big companies with big money pay a lot to get their drugs approved. Too often, a drug gets passed, people start croaking, the drug is taken off the market and then someone reveals the researches were well aware of how dangerous the drug was before it got approved. They are killing people to make a buck. It doesn't help when drug companies know of risks but don't list them, so doctors don't know the drug is dangerous for certain people.

Anyone who argues that is one of the many corrupt researchers or drug company employees that are murdering people.

JJ 10-05-2006 @ 9:57AM

BTW, accupuncture has been around for thousands of years and is tried and true. Modern medicine is still too young and hugely expirimental.

M. L. M. 10-05-2006 @ 9:59AM

There's a very interesting book out--& it's on CD for easier listening--entitled "What the Drug Companies Don't Want You to Know." It's a real eye opener. It's the the taxpayer who is paying for all kinds of research that the drug companies take credit for, when actually universities receive grants from the National Health Institute to do the research, which they in turn sell the formula to the drug companies & receive royalties. Then the drug companies tie up brand name drugs with legal action by making new use claims for their drugs that give them additional time on their patent time. We pay double & through the nose for all these drugs. Some of the companies claim they need to charge high prices to "recoup their R&D costs," which have already been paid to universities via grants, not the drug companies' costs.

In answer to the question "So who loses in all of this?", the correct grammer is "You and I."

If you finish out the sentence using the whole answer, you would say "You and I lose in all of this," not "You and me lose in all of this." Singular noun & singular verb.

E. Edward Blakeman 10-05-2006 @ 10:01AM

I used to trust my doctor with making decisions about what medications to take. Not anymore, after retiring from Law Enforcement (20 years) and still working in Corrections. I have never even had as much as traffic ticket. My wife of many years started having an affair. I became depressed so I went to my Doctor and asked for help. He gave me Zoloft a common anti depressant. After a week with no sleep and a growing uncontrolable rage, I went back to him and asked for something else. He insisted that I keep taking the Zoloft and doubled the dose. After a week of breaking everything in my home my wife took me back to the doctor and we begged for a different medication. He scolded us and said the anger was from lack of sleep. He then gave me Ambien and again doubled the Zoloft. I went home and after about 3 days with still no sleep I began slashing myself with a knife, I took a shotgun and shot my computer. I told my wife to leave and prepared to comit suicide. I was completely out of control. Parts of what happened I can't even remember. I do remember waking up to find 2 swat teams in my yard. They were shooting teargas rounds through the walls of my house. Explosive devises were blowing up what was left. I was arrested for 3 felonies and I am facing 21 years in prison for refusing to come out of my own home. My attorneys have been able to get Emails between my doctor and the pharmasutical co. The Emails show that the doctor was been paid large monthly payments to use Zoloft and increase the doses to the highest doses.

If you or a friend are depressed DON,T take antidepressants. The only safe class of medication are mood stabilyzers. They are nonaddictive and have almost no side effects. But they've been around for thirty years so they're very cheap. The drug companies want you to buy the 12 dollar a pill medications and they'll destroy your life or even kill you to make they're profits!

I finally found a good doctor that started me out with an exercise routine, combined with St. Jonh's Wort an over the counter herbal supplement. He also gave me Lamictal a mood stabilyzer. He told me that the drug companies are no different than any other drug pusher on the street, they're going to make they're money and crush anybody that gets in they're way.

As a result of this situation, I've lost my job as a Sergeant with a state prison, it put the final death nail in my marriage, I have not been allowed to see or speak to my 13 and 7 year old sons for over a year now. I have lost my pension that I worked 20 years for as a Police Detecive, the legal fees have bankrupted me and I'm loosing my home I've had for 20 years.

Daryl Kulak 10-05-2006 @ 10:24AM

Hi everyone,

#2 - In acupuncture, the needles are sterile and used one time only. Infection is not much of a risk.

#4 - I agree with much of what you say. However, I wouldn't say that anyone who argues in defense of the FDA is a drug company shill. Not at all. I see many people arguing for the FDA here and in on other blog posts, and they are simply people who still believe that it and the drug companies are doing the right thing. I actually think a majority of Americans still believe that, even in the face of all evidence. But that doesn't mean they are being paid off or anything. It's just a matter of education.

#5 - I totally agree. A medicine that's been tried for thousands of years does have an advantage over a drug introduced three years ago.

#6 - Thanks for the tip about the CD (and the grammar advice!)

#7 - All I can say is Wow! Thank you so much for posting, Edward. You have really given us an insight into the bad side of these drugs. I'm going to direct people from my other post (Five Foods to Beat Depression) to your comment as well. Thanks and best of luck.