Who is watching the watchers?

Back in May, the Wall Street Journal ran a shocking story that began with a man named Thomas A. Marciniak. Dr. Marciniak reviews new drug applications for the FDA.

Yes, Dr. Marciniak is like one of Dr. Seuss’ “watchers” at FDA. But he also knows a thing or two about cancer. He specialized in it during his medical residency at the Mayo Clinic. Then, he spent a decade at the National Cancer Institute before going to work for the FDA.

In 2010, Dr. Marciniak came across a study published in the British medical journal Lancet Oncology. The study linked the FDA-approved blood pressure drugs called angiotensin receptor blockers (more commonly known as ARBs) with cancer. Benicar and Micardis are two common ARBs.

The Lancet review examined five different studies involving 68,402 patients. It showed that men and women who took ARBs had an 11 percent greater risk overall of getting a new cancer. And they had a 25 percent greater risk of getting new lung cancer. That’s compared to patients who didn’t take ARBs.

The findings prompted the FDA to put together its own “meta-analysis” to review the published data on ARBs. But its investigation didn’t turn up any “increase in risk.” And the agency gave the drugs a pass.

However, as I’ve said before, you can’t trust meta-analyses. They aren’t reliable. Any statistician with a “creative” flair can wash away the results. And that may be one reason why the FDA favors them in the first place.Turns out, Dr. Marciniak didn’t trust the FDA’s meta-analysis, either. And knowing that millions of men and women take these blood pressure drugs, he began his own investigation into ARBs.

Dr. Marciniak went through the raw data, patient by patient–an extremely laborious process. And his preliminary results mirror those published in Lancet Oncology.

As a result, he lobbied his bosses at the FDA to add stronger warnings about cancer to the labeling of these blood pressure drugs. But his political-science superiors at the FDA blocked his efforts.

And last August, they ordered him to stop his work with ARBs. Even though Dr. Marciniak only requested 62 more “person days” (two months of work for one person) to finish his raw data investigation.

This, from another government agency that wastes millions of “person-hours” and billions of tax dollars on nonsensical “training” exercises, out-of-town junkets disguised as “conferences,” etc. Not to mention the routine wasteful pencil- and paper-pushing considered “work” in the government.

In an email, Dr. Marciniak urged his boss to reconsider. He wrote: “The FDA needs to inform patients and physicians about the ARB lung-cancer risks. The FDA must act now.”

To which, his boss wrote back that even if Dr. Marciniak found an increased cancer risk of 30 percent, it would not generate “enthusiasm” for increased “regulation.” Not even labeling the drug with a warning!

If a 30 percent increased cancer risk isn’t enough to get the FDA to “act,” then what is?

Remember, we are not talking about pulling the cancer-causing drugs off the market. Dr. Marciniak just wants the FDA to issue a toothless “warning.” So we can at least inform doctors and patients about the drugs’ risks!

Fortunately, Dr. Marciniak is not alone. Others in the scientific community also voice concerns about the new evidence.

Even still, this glaring example spotlights a larger problem within the entire drug approval process.

And it all goes back to what I’ve repeated about the importance of continuing to monitor drugs after the FDA has approved them as “safe and effective.”

You see, the FDA bases its approval on trials that involve very limited numbers of selected patients. And very often, the trials involve patients who don’t accurately represent all the types of patients who will ultimately end up taking the drugs.

For example, let’s say drug makers give drug XYZ to a healthy 40-year-old patient with depression according to their “selection” criteria. But most of the people who end up taking the drug are depressed patients with high blood pressure. Of course, drug XYZ may well behave differently for those patients.

After this negligent approval process, the FDA turns the drugs loose on potentially millions of patients. Only then do we see all their real side effects.

The WSJ article also found that the FDA prioritizes the processing of even more new drug applications over following up on the safety of approved “blockbuster” drugs already on the market.

Meanwhile, just down the medical Beltway Bandit thoroughfare of Rockville Pike in Maryland, the research billionaires at the National Cancer Institute would be doing cartwheels if they could find any dietary factor that increased cancer by 30 percent! They’ve tried to peg it on eggs, meat, saturated fats, and salted foods. Of course, these attempts all failed, despite their best efforts.

Now we know, the NCI has been looking in all the wrong places. If they want to find what really increases cancer rates, they should look at drugs, not foods!

Of course, many safe alternatives can help you control your blood pressure. You can learn all about them in my special report called The Insider’s Secret to Conquering High Blood Pressure & Protecting Your Heart. Subscribers to my newsletter get this report for free. Not a subscriber yet, get started today.

In the meantime, here are three important lessons to keep in mind:

1. The FDA can’t be trusted.

2. New drugs can’t be trusted.

3. If you take a drug to treat high blood pressure, ask your doctor about choosing an older one.

Source:

1.“Dispute Flares Inside FDA Over Safety of Popular Blood-Pressure Drugs,” Wall Street Journal (online.wsj.com), May 30, 2013

 

 

 


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