Dr. Mark Hyman explains how the FDA's drug approval process fails consumers. Pharmaceutical companies hide negative studies, and drugs like Zetia don't work as advertised. He argues for transparency and lifestyle-based health over pills.
You- doctors think they make decisions based on medical evidence, but they don't. Hi, this is Dr. Mark Hyman. Half of medical evidence is hidden, and that's the half that shows that drugs don't work. Now, partial evidence that is not hidden is twisted to lead doctors to believe that drugs do what they're supposed to do, even when they don't. The bad news is that drug companies are not pleased by the FDA the way they should be. A drug should be proven to be both safe and effective before it is unleashed on millions of people. Two recent examples highlight the dangers of the collusion between drug companies and our government agency, the FDA, which should be called the Federal Drug Aid instead of the Food and Drug Administration. First, the headline news is that cholesterol-lowering drug Zetia, actually causes harm and leads to faster progression of heart disease. Now get this, despite lowering cholesterol 58% when combined with Zocor. This actually brings into question the unchallenged belief that high cholesterol causes heart attacks and shakes the $40 billion cholesterol drug lowering industry at its foundation. And second, the news that nearly all negative studies, which account for about half of all the studies looked at on antidepressants, were never published, giving a false sense of effectiveness of antidepressants to treat depression. Now don't blame your doctor. Blame the deceptive scientific practices and industry protective government policies. These findings are the crack in the medical establishment. They are not egg on your face, they are blood. Let's take a closer look at these findings and their implications. You know, I once had a patient who worked in the approval division of the FDA and she taught me a very important lesson. When a drug designs, a company designs and performs a study, it has to be registered with the FDA, and all the results have to be submitted to the FDA. But the pharma companies only submit the data that they want to get published in medical journals. That means that any negative studies that they do are hidden from the scientific community and hidden from the public. And when drug studies are sponsored by drug companies, as most are, they mostly find positive outcomes at the rate of 4 to 1 compared to independently funded studies. The FDA does not release this information. And that was until 2004 when all major scientific journals banded together and refused to publish any data from any drug study that did not list the results of all trials, either positive or negative, on a central database. Well, that sounds good, right? But listing obscure, unpublished studies buried deep in a hard to navigate public database run by the NIH is hardly visible public disclosure. Now, the research studies done are early listed, but you try to find the results. After a few hours of searching around, I gave up on this site called clinicaltrials.gov and last year Congress did pass legislation expanding how much detail should be listed, but at the end of the day, who even looks at that, right? Most doctors don't even have time to read their medical journals. They get bite-sized bits from drug detailers coming to their office with lunch and a sound bite about their drug. and they get slightly more information from researchers funded by pharma presenting their findings at conferences sponsored by pharma using presentations prepared for them by pharma, not exactly independent evidence-based medicine, right? Now back to Zetia and the whole cholesterol thing. Here's basically what happened. A new drug was invented that lowered cholesterol by a different mechanism than statins like Lipitor or Zocor. Doctors have been brainwashed to think that cholesterol is the cause of heart attacks. Even though half of all people who have heart attacks have normal cholesterol. And it seemed that like statins which lowered cholesterol actually reduced heart attacks. So it seemed logical, right? Lower cholesterol, reduce heart attacks, cause and effect, no? Well, no. I believe that the reason statins lower risk is not because they lower cholesterol, but because they reduce inflammation, which is a side effect the drug makers didn't even know about until after the drug was released. In fact, studies by Dr. Paul Ridker of Harvard showed that reduction in your risk of heart attacks only happened if you lowered C-reactive protein along with LDL, but not if you just lowered your LDL cholesterol. So then along comes a drug that can be combined with statins to lower cholesterol even more. Great idea. Well, not really. Imagine this. Zetia was approved without the FDA having any proof that it lowered heart attacks or reduce the progression of heart disease, but solely based on the idea that it lowered cholesterol and that lowering cholesterol was a good thing. It was given to 5 million people and made the drug companies $5 billion a year, or almost $14 million a day. Now once the drug was approved, the makers of Zetia had no incentive to do more studies to prove that it actually did what it was thought to do, lower heart attacks. So they dragged their feet in doing these studies and then they released the negative data, which they did only under pressure from news agencies and Congress, after a long delay of nearly two years. Wouldn't you drag your feet if you were making $14 million a day? But the FDA had the data. They have had all the data. Why didn't they speak up? Are they responsible for more deaths in the war in Iraq? I mean, what's going on? Once the bad news hit the media, the Independent Heart Association, American Heart Association, said the study was too limited to draw conclusions about Voitin, which is a combination of Zidovudine and Zocor, about its ability to reduce heart attacks or deaths compared to Zocor alone. We had too limited information. Well, let's look behind the headlines. The American Heart Association recommended that patients not stop taking the medication without consulting their doctors. But what they didn't say was that they received $2 million in funding from Schering-Plough and Merck, the makers of Voitin. Oh, sorry, forgot to mention that, right? The data that was withheld proved that Zaditor did not reduce heart attacks but actually increased fatty plaques in the arteries despite lowering cholesterol. Now let that sink in. Increased plaque despite lowering cholesterol. So lowering cholesterol led to more heart disease. That turns our whole medical model upside down. High cholesterol is not a disease or may or may not be related to heart attacks. This year another study put another nail in the coffin of the cholesterol myth. A major new cholesterol drug called torcetrapib developed by Pfizer was pulled from the pipeline in December 2006 because despite lowering LDL and raising the good cholesterol HDL in 15,000 people, it caused more heart attacks and strokes. This was to be the new wonder drug for cholesterol. Oops. This points to a whole new research mess that is flawed in three ways. First, what gets studied depends on who's funding it. since drug companies fund most of the research in the world, other therapies that work better never get enough funding such as diet and lifestyle and nutritional therapies. Second, drug companies aided by the FDA, which should stand for Federal Drug Aid, suppresses, hides or doesn't publish negative studies on drugs, only positive ones, leading doctors to think that they have evidence when it's mostly propaganda. And third, doctors and patients and the media believe they have the whole truth even and often until it's too late, such as with like Zetia or Premarin or Vioxx. The evidence was there, no one looked for it or publicized it. This makes it very difficult for consumers, but here's my advice on how to make sense of things. Follow the money. Look carefully at who funded the study. Be suspect if it's funded by drug companies. Two, call or email your congressman or senator to demand better legislation providing an easy way to navigate a database of all drug trials with consumer friendly summaries of both published and unpublished data submitted on drugs to the FDA so you can look up the prescribed drug that you're taking and have a balanced opinion. And three, don't assume that drugs are the answer to your health problems. Heart disease is not a lipitor deficiency but the result of your lifestyle interacting with your genes. And learn to ask the question why. and search for the answers. Dealing with lifestyle and environmental factors, which is the basis of ultra wellness, almost always works better for chronic illness and drugs are there only as a backup if needed. Thank you. This is Dr. Harneyman.
