The FDA: Friendly Neighborhood Watchdog? Or Big Pharma Lapdog?

The other day a friend of mine, a nurse, by the way – touted the benefits of a weight loss remedy that has helped her to lose 31 pounds. Confident in her results, the only drawback she saw is that the drug was manufactured in China. Faces around the table fell. Manufactured in China: melamine poisoning and lead contamination. No, thanks. “But when you think about it,” I commented, “you don’t have to go to China to get tainted drugs. We have plenty of unsafe drugs right here in the good, ‘ol U.S. of A.” Turn on the tube and you see some drug maker pushing a new pill; turn the channel and there’s a lawyer suing over its adverse effects. It’s the job of the FDA to ensure that drugs released to the market are both safe and effective. But when it comes to the approval of pharmaceuticals, half of the medical evidence concerning them is hidden – the evidence that the drugs don’t work. Drugs just aren’t policed as they should be because the FDA and U.S. drug companies make very cozy albeit very strange bedfellows. Never mind the “U.S. Food and Drug Administration,” a more accurate description of the FDA might be “Federal Drug Aid”.

No government agency can operate effectively when there is a revolving door between it and the industry it is supposed to regulate. But in America the door of separation between the FDA and Big Pharma is turning 24 hours a day. A survey released by the Consumer Reports National Research Center in 2007 showed that 84% of us think that drug companies have “too much influence over the government officials who regulate them.” Over two-thirds of us are concerned over the fact that drug companies actually pay the FDA to review and approve their drugs. (Americans know their stuff, it turns out. When drug studies are funded by drug companies, positive outcomes are found at a rate of 4 to 1 over independent studies.)

92% of those surveyed agree that pharmaceutical companies should disclose the results of ALL clinical trials, not just the positive ones they want to advertise. Drug companies have buried negative drug trials and the FDA has been caught conspiring with drug companies to conceal negative drug data from the public. (To combat this, the scientific journals banded together in 2004 and refused to publish data from any drug study that didn’t publish results from all trials, positive and negative, on a central database. But listing obscure, unpublished trials in a hard-to-navigate database run by the National Institute of Health is hardly useful public disclosure.)

60% of survey respondents agreed that doctors and scientists with a financial conflict of interest should not be allowed to serve on FDA advisory boards. Doctors who earn thousands of dollars in “consulting fees” from drug companies are not only allowed to vote on recommendations for FDA approval of their drugs, there is not even any FDA requirement to disclose such conflicts of interest. (To further muddy the waters, salesmen or researchers funded by Pharma present findings at conferences funded by Pharma using presentations prepared by Pharma….!)

To put the survey results into perspective, consider cholesterol. Because a cause and effect relationship between high cholesterol and heart disease is pretty much the prevailing wisdom in medical circles, the drug industry makes a whopping 40 billion dollars a year in sales of cholesterol-lowering medications. But here’s an interesting twist: the cholesterol-lowering med, Zetia, speeds progression of heart disease DESPITE lowering cholesterol when combined with Zocor, a statin drug. This startling finding sets the drug business on its head, according to physician and four-time NY Times best-selling author, Dr. Mark Hyman, because the question of whether or not cholesterol causes heart disease was supposed to be settled. Physicians have come to believe that high cholesterol causes heart disease because the studies pushed forward by the drug industry tell them so. Statin drugs block the formation of bad cholesterol, or LDL, in the liver, but it turns out that statins actually lower risk because of a side effect not known about until after the drugs were released – they also lower inflammation. Harvard physician Paul Ritger found that heart attack risk is lowered only if c-reactive protein levels in the blood are lowered along with LDL, not just by lowering LDL levels alone. C-reactive protein levels rise in response to inflammation. Zetia was meant to be paired with cholesterol-lowering drugs like Zocor or Lipitor in order to lower cholesterol even more. The FDA released Zetia without any proof that it prevented heart attacks or reduced the progression of heart disease, but only with 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 about 5 billion dollars a year. That’s almost 14 million dollars a day, so when Zetia was released the drug companies had no incentive to conduct studies to prove it does what they say it does – reduce the risk of heart attack. Only after two years of foot-dragging and pressure from news agencies and Congress were the studies done and the negative data released. The FDA had the data. The question is why didn’t they speak up? Once the bad news hit the media the American Heart Association said the study about Vytorin, a combination of Zetia and Zocor, was too limited to draw a conclusion about its ability to prevent heart attacks when compared to Zocor alone. They released a recommendation that patients not stop taking Vytorin without consulting their doctors. But what they didn’t say was that they had received 2 million dollars in funding from Shearing-Plough & Merck, makers of Vytorin. The study showed that Zetia did not lower the risk of heart attack and increased fatty plaques in the arteries despite lowering cholesterol. Let that sink in for a moment. Lowering cholesterol led to more heart disease and turns our whole medical model upside down. High cholesterol, in other words, is not a disease.

What we have in America is a research mess that is flawed in 3 ways: 1. What gets studied depends on who’s paying for it, so drug companies don’t pay to study therapies that might work better, like diet and exercise. 2. Drug companies, aided by the FDA, suppress, hide or do not publish negative studies, only positive ones. This leads physicians to believe that the studies provide actual evidence instead of corporate propaganda. 3. Doctors and patients believe they have the truth even when it’s too late. The data is there but no one publicizes it.

What to do when it seems like you just can’t fight City Hall? Follow the money. Be suspicious of any study funded by drug companies. Call your representatives in Congress and demand better legislation regarding easy navigation of a database of all drug trials with user-friendly summaries of published and unpublished data submitted to the FDA. Everyone should be able to look up any drug to get balanced opinions regarding it. Finally, don’t assume that a prescription drug is the answer to your health problem. Many illnesses are the result of your lifestyle interacting with your genes.  Learn to ask, “Why?” and search for the answers. Lifestyle choices can do much to help us prevent or cope with illness. Ask your doctor to try everything else first. Then insist that the drug companies put prescription drugs where they belong – in the back-up position.

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