I Have a Theory About Vioxx (1 Viewer)

and some of the other drugs that are out there where they've found increased risks of heart attacks and strokes. Specifically, I'm thinking about the drugs that have to do with pain reduction. I was wondering if perhaps the reason for these increased deaths isn't due to the drugs per se but because the people have become signficantly more active and it's this increased physical activity that's causing these deaths. I haven't looked into this very closely and I'm wondering if this possibility has been studied? I'm figuring that if people have some sort of existing problem, then simply becoming more active can also result in deaths. I'm thinking along the lines of Jim Fixx or Pistol Pete who both died during physical activity and had (I think) pre-existing medical conditions. Does anyone know?

Could be. It could also mean the pain reduction properties are masking the preliminary symptoms of a heart condition (such as angina) and thus the condition worsens and leads to a full blown MI. Many cause and effect questions which may not be answered without further testing, but pulling of the medicine is both morally and legally (let's face it, the only reason is liability) the prudent thing to do.

One could argue the opposite: that the drugs helped restore mobility to people whose movement was otherwise limited by arthritis, thereby allowing them to become active again, which could have the effect of strengthening the heart, lowering cholestorol, etc.

M.

It could be the new way the FDA opperates where controls are much less stringent than they used to be.

It's more likely that the strokes and heart attacks are due to the mechanism of action of the drugs. These drugs inhibit an enzyme called cylcooxygenase-2 (hence the name COX-2 inhibitors) that controls the production of substances like prostacylcins and prostaglandins that produce pain and inflammation. Unfortunately, inhibiting the enzyme also makes platelets more sticky. The platelets clump together, and are more prone to making clots, which lead to strokes and heart attacks.

We know that people who take aspirin to prevent strokes and MIs loose that protective effect when they are on medicines like Vioxx, Celebrex, Naproxyn or Ibuprofen.

The issue is not that these medicines have side effects, but rather that they are being over-marketed and over-prescribed. If they were only used by people who really needed them, i.e. people with bad arthritis who can't take other pain medicines, the risks might be worth it. When they are used by anybody for almost any kind of pain, the risks outweigh the benefits.

Tom Fynan

Good info Tom.

The bigger picture is that the FDA has lost it's function as an independent body. DRugs approved for public use should be done by independent scientists not beholden to drug manufacturers and FDA bureacracy.

Well, the original purpose of the FDA was to get drug testimonials and testing out of the hands of individuals, who might concievably be corrupted by money!! and into the hands of a disinterested party, i.e., the guv'ment. Ironic, ain't it?

"Well, the original purpose of the FDA was to get drug testimonials and testing out of the hands of individuals..."

Julian, that's the point I was trying to make. That is the intent of the FDA but they have lost the public's trust and may not be independent and objective as they should be.

The FDA gets beat up when it takes "too long" to get needed drugs to market and adds tens of millions in development costs and decades in development time to the creation of new drugs. Then they get beat up when one quesitonable study casts doubt on a drug.

Vioxx was not pulled by the FDA. It was voluntarily pulled by the drug maker - which feared LAWSUITS. In the study cited the SAME NUMBER OF PEOPLE from the control group had fatal heart attacks as did Vioxx patients. That's right - 25 people taking the frickin' SUGAR PILLS during the study died. More Vioxx patient suffered strokes, but more didn't die - and the whole sample was only about 2500 people. The Celebrex study involved an experimental use of the drug over a long period and in very high doses to see if it had any effect on altzheimers, a disease for which it had not previously been prescribed.

If you take ANYTHING in very high doses over many years it can kill you - oxygen and water included. Everything bad that happens in the world is not the fault of some company or individual. It is not fair to demand that the government and companies be clairvoyant, which seems to be the currrent standard. The world does not owe everyone a risk-free existance.

But the lawyers will keep demanding this, lying to their clients to convince them that such a world is possible and tell the same lie to juries -- not because they themselves believe a word of it, but because that's how they make their money. Meanwhile drug and other medical costs continue to go up, and necessary drugs are kept off the market or removed from it. (Which then lets the lawyers sue the drug companies for withdrawing the drugs.)

Regards,

Joe

The FDA also dropped the ball in recognizing the quality control issues in the flu vaccine debacle. Thank goodness the British government had the balls to shut down that site.

Drew,

The plant you are talking about is in Liverpool, England. I don't think the FDA lacked "the balls" to shut that plant, they lacked the authority. Imagine the US reaction if the British sent a bunch of guys in red coats to shut down a plant in the US. We could potentially stop the vaccine at the border. But I'd rather have the FDA working on approving new medicines than policing foreign manufacturing.

More general points,

The reason so few companies make flu vaccine is that they don't make money at it. Profit is the reason studios make movies, compaines make speakers, automakers make cars, doctors practice, and yes why drug makers make drugs.

Everybody wants something for nothing and then they want to sue the deepest pockets when it doesn't work. Now if the US had some balls, they'd do something about the entire world free riding on our expenditures on drug R&D.

It's amazing to me that many care more about the property rights of the music industry (vs. Napster et.al.) than that of the pharmaceutical industry.

"But I'd rather have the FDA working on approving new medicines than policing foreign manufacturing."

Are you kidding me? The FDA saw earlier reports citing quality control concerns and did NOTHING until the British surprised everyone with the ban. The FDA didn't have to physically shut it down, all they had to do was raise their concerns and the plant would have been effectively shut down.

The US is/was depending on one or two suppliers of the vaccine for millions and you are willing to leave inspections up to others? I don't think so.