Better Safe Than Sorry

There is an interesting and major difference in the attitudes of Americans and Europeans regarding products. In America we let almost everything come to market in order to let the free enterprise system work and if there are any safety problems, well, those will show up later. Europeans take much safer (and wiser in my opinion) attitude and assume everything is dangerous and only allow a product to be sold if it's been proven safe.

This issue comes to mind again with the recent publication in Pediatrics magazine about the dangers of the widely-used chemical bisphenol-A (BPA). In a recent study it was shown that exposure to BPA even before birth can impact the health of a child. Preschool-age children whose mothers had relatively high levels of BPA during pregnancy scored worse (but still within "normal" range) on behavior measures. These behaviors included anxiety and hyperactivity.

Meanwhile the Food and Drug Administration (FDA) continues to study BPA exposure.

GAO Criticizes FDA

The General Accounting Office (GAO) has criticized the Food & Drug Administration (FDA) for being too lenient in clearing critical, life sustaining devices. Meanwhile device manufacturers complain the U.S. is too slow compared to other countries.

The GAO told Congress this week that the approvals remain a serious issue even though it was raised more than two years ago. It should be noted that the device manufacturers major trade association, AdvaMed, has spent hundreds of thousands of dollars lobbying against any new device regulations.

Senate Aging Committee Chairman Herb Kohl, D-WI, said, "The drive toward getting new technologies to market shouldn't be done at the risk of patient safety."

FDA Restrictions

The Food & Drug Administration (FDA) has asked prescription drug manufacturers to limit the amount of acetaminophen to 325 milligrams. The move is in response to the increased risk of liver damage from the drug and to the amount used in a wide variety of over-the-counter medications. In other words, we're getting too much of acetaminophen from a wide range of sources.

It's a start.

FDA Revokes Avastin

Once again a drug approved by the Food & Drug Administration (FDA) has later been proven to not be worth the risk. This time the FDA even pulled its approval of Avastin for treating breast cancer. Later studies showed the drug to be unsafe. There were "significant" increases in serious side effects with the drugs use including blood clots, bleeding and even heart failure.

Avastin is the world's best-selling cancer drug with global sales of $5.8 billion making it the top product for Roche. The drug is used to treat more than 17,000 breast cancer patients every year. It can still be used to treat tumors in the colon, lung, kidney and brain. Doctors could even continue to use it for breast cancer by using it "off-label" even though the FDA recommends against it. Avastin is also one of the most expensive cancer drugs in the world. It costs a patient (or their insurance company) about $8,000 PER MONTH for treatment.

Food Health Dangers

You've probably already heard of the growing concern over the chemical BPA in our food supply but a new study raises the level substantially. A coalition of 17 public and environmental health groups analyzed can from 19 states and Ontario, Canaca and found 92% of them contained the chemical. BPA has been associated with several different damaging health effects and there is a growing chorus of people asking for it to be banned from our food supply.

Sen. Dianne Feinstein, (D. California) has already called for a ban on BPA in food and beverage containers saying "Nearly 200 scientific studies show that exposures to low doses of BPA, particularly during pregnancy and early infancy, are associated with a wide range of adverse health effects later in life."

In my most popular speech on complementary and alternative therapies (Secrets of New Science & Old Medicine) the handout has a picture of the Agouti mice at Duke University. The photo is about epigenetics but the environmental factor producing obesity in the mice was exposure to BPA. You can hear a podcast of this presentation at www.unbreakyourhealth.com.

Human Guinea Pigs

More fun and games at the Food & Drug Administration (FDA) as they continue to allow the pharmaceutical industry to use the population of America as human guinea pigs. This installment is about how the FDA finally got around to putting a "black box warning" on Bristol-Myers' best-selling drug Plavix. It seems that up to 14% of the population may have a genetic variation that makes it difficult for them to metabolize the drug, or as the FDA says they "may not respond well" to the drug. Plavix is also marketed by Sanofi Aventis and is the second-best selling drug in the world with $8.6 Billion in sales in 2008.

The FDA also recently announced it's conducting a review of a class of bone-building drugs featuring products like Boniva to see if they actually increase the risk of femur fractures as has been reported in the media. Bisphosphonate drugs have also been reported to have severe side effects like jaw necrosis, heart rhythm disturbances and severe bone and joint pain. How many years will this review take and how many people will be injured in the meantime?

People simply don't understand and appreciate that they're being used as human guinea pigs, they think the FDA is protecting them.

And the medical industry wonders why consumers are turning to complementary and alternative medicine?

More FDA Troubles

Has anyone missed the news reports in the past week about the Food & Drug Administration (FDA) and Avandia? It's just the latest chapter in the FDA's troubled attempts to regulate safety in prescription drugs.

This episode involves the diabetes medication Avandia from GlaxoSmithKline. The flap was ignited by reports linking it to 304 deaths in the 3rd quarter of 2009. The New York Times reported that if every patient taking Avandia were to switch to a similar drug called Actos about 500 heart attacks and 300 cases of heart failure would be averted every month. Naturally the manufacturer continues to claim that the drug is safe since sales were $3.2 billion in 2006.

Meanwhile more trials are underway while the FDA continues to abdicate its responsibility to protect the health of Americans. The current TIDE study isn't even scheduled to be completed until 2020. How many thousands will die as a result of this bureaucratic ineffectiveness?

FDA Fails to Remove Unproven Drugs

The FDA has allowed drugs for cancer and other serious diseases to stay on the market even when their effectiveness is unproven. Under the "accelerated approval" program a drug can be made available when preliminary research is promising under the promise of follow-up data. However even after a decade of no additional information the FDA doesn't take any action, in fact it has never pulled a drug approved in this manner from the market. When questioned by the GAO about the issue the FDA said it doesn't even have any plans to get more aggressive on enforcement.

Is this how the FDA protects the public or the drug manufacturers?

No Safe Drugs

Americans believe that if the Food & Drug Administration (FDA) approves a drug then it's safe. They don't realize that there is no such thing as a drug that's 100% safe, even over-the-counter drugs. By now you've probably heard the news that the FDA is considering tough new standards for Tylenol and other products that contain acetaminophen including reduction in recommended dose, a possible "black box" warning and even elimination in some products such as Vicodin and Percocet.

The actions are being considered because acetaminophen is responsible for 56,000 people going to the emergency room and around 200 deaths each year due to liver damage. No one can even estimate the number of people who may suffer liver damage from these popular products. There is no such thing as a completely safe drug.

In contrast, none of the 300+ therapies listed in my book on complementary and alternative therapies send thousands of people to the hospital every year or kill hundreds. And doctors say complementary and alternative medicine is dangerous?

Congress's Sting Catches Colorado Company

A congressional sting operation has caught Coast IRB. The company approves clinical-trial designs and patient-safety guidelines but it appears their first concern is profit, not patient safety. Their work involves oversight of patient safety during clinical trials and they will now voluntarily halt many of their review operations at the request of the Food and Drug Administration according to the FDA. The action could affect 300 trials involving more than 3,000 researchers and includes work for several major pharmaceutical, biotechnology and medical-device companies.

It's about time somebody stepped up and started looking out for us!

Rife On Trial

Jim Folsom is going to prison. You've probably never heard his name or even the name of the device he sells, a Rife Machine or Rife Beam Ray Device, but anyone wanting better health without drugs has lost something today. Big Government (FDA) once again wants to take away a safe device that is being used in Europe today and has been used in this country since the early 1900's.

The technology is even being researched today by approved medical institutions because it does work. Now it's called laser technology using frequencies to explode viruses but decades ago it was simply called a "beam ray device" by Royal Rife. Interesting that this device predates the FDA by decades but they are obsessed with eliminating this threat to their friends in the drug industry.

Anyone who thinks they have freedom in America today isn't paying attention. Whenever there is money and power at stake, freedom is the first casualty.

FDA Works For ?

You've probably heard that those wonderful folks who brought you Thalidomide, Vioxx and other wonderful drugs, the Food & Drug Administration (FDA), have now decided that a little melamine is safe for babies. The deaths of children in China apparently has taught them nothing about the situation.

"This FDA, this Bush administration, instead of protecting the public health, is protecting industry," said Rep. Rosa DeLauro (D-Conn.), who chairs the Appropriations subcommittee that oversees the FDA budget. In an interview, DeLauro said she wants the agency to disclose its findings and to develop a plan to remove melamine from formula. "We're talking about babies, about the most vulnerable. This really makes me angry."

'Nuff said.

FDA Advisory Group Disagrees With FDA

The FDA asked a panel of scientific experts to review its August report claiming that BPA was safe. Now that panel of science experts challenged the Food and Drug Administration's conclusion noting the FDA should have paid more attention to studies suggesting the contrary, primarily those not supported by the plastics industry.

The FDA report issued in August said that BPA is safe at current levels. Lawmakers and scientists criticized the report because it relied largely on industry-funded studies and contradicted over 100 studies suggesting BPA is harmful to humans. The FDA says it is already moving forward with planned research to address the potential low-dose effects of BPA.

Congress Questions FDA Action

You know the FDA is doing a pretty poor job when both Democrats and Republicans in Congress have questions about its work. This week the issue is why the FDA's advisory panel only used research funded by the chemical industry as the basis for its recent report that BPA is safe and harmless ... ignoring even the government's own research. Congress has asked specific questions of the FDA on this situation and is waiting for a reply. The advisory panel is scheduled to release its review of the FDA's report on BPA before it meets Oct. 31. The panel will present its findings to the FDA's Science Board, which may issue its own assessment of the agency's work.

Just last month (as noted in this blog) the Journal of the American Medical Association linked BPA to heart disease and diabetes in adults. Canada last week declared BPA to be toxic and announced plans to ban it in baby bottles. A growing number of retailers, manufacturers and government officials are taking action against BPA including state attorney generals in several states.

Drug Reactions, Deaths Rise

Another day, another news report about the increasingly dangerous world of prescription drugs. Today it's a report from the FDA about the first quarter stats this year showing 21,000 reports of serious drug reactions including 4,800 deaths. This dramatic increase sets a new record, not the sort of news the drug companies want you to hear.

The numbers reflect a 38% increase over the previous four quarters and was almost 3x higher than any quarter in 2007. You'll be glad to hear their spokesman say "The FDA is aware of the increasing number of reports and we take them seriously."

And the medical community wonders why more and more people are turning to complementary and alternative medicine?

BPA Study Links Health Problems

Suspicions about the effect of bisphenol A (BPA) on human beings has been confirmed in the first large study on the product. Research published this week in the Journal of the American Medical Association compared the health of 1,455 men and women with BPA in their systems. Those with the highest concentrations of BPA were nearly 3x more like to have cardiovascular disease and 2.4x as like to have diabetes than those with the lowest levels.

In Congress Sen. Charles Gressley, R-Iowa has opened an investigation into the way the FDA regulated the chemical. In addition Congress is looking into whether chemical manufacturers unduly influenced the agency's position.

How long will it be before somebody gets this stuff pulled off the market?

Drug Company Scam

Drug companies have found a way around the FDA requirement that they warn consumers about the dangers in their products. After all, Eli Lilly's ad for Evista doesn't want to spend 25 seconds of their 60-second TV commercial warning about such side effects and blood clots and dying from stroke. Now companies are using ads that don't mention their drug. Instead the promote the problem, like stopping smoking, and refer consumers to a website that has a link to Chantix. It's a 2-step dance around FDA rules but it more effectively captures potential customers because it doesn't scare them away with side effects of the drug like DEATH.

When are our elected officials and the FDA going to realize the American experiment with allowing direct-to-consumer advertising of prescription drugs has been a disaster for health in our country? We have only 4.3% of the world's population but we consumer 48% of the world's prescription drugs ... yet only rank #30 in longevity (worse in other categories). There are only 2 countries in the world that allow it, and the othe one is already looking at discontinuing it because they're seeing the same pattern of abuse.

WAKE UP CONGRESS! Or are you just too happy with all of the political contributions from the drug makers? Didn't we vote you into office to protect our welfare, not the welfare of the drug companies?

Drug Timing

Is it a coincidence that 14 of the 21 drug withdrawals or black-box warnings for drugs approved since 1993 were approved within two months before the deadline for new drug applications? To look at it another way, the 97 drugs approved near the FDA's deadline had a 14% rate of severe safety problems compared with a 3% rate for 216 other drugs.

Could it be the FDA's effort to "fast track" drug approvals is leading to cutting corners? Today the agency promises to decide on 90% of drug applications within 10 months. In 1991 it took them 33 months to decide on a new drug. Drugs like Vioxx, Baycol and Rezulin were all approved within two months of deadline. There is no law forcing this schedule, just politics and pressure from the drug industry in a rush to make money. While some people can't wait for the newest drug, others pay a deadly price for such haste.

Compare this system to the world of complementary and alternative therapies which have been around for decades, hundreds ... sometimes even thousands of years. Regardless of what mainstream medicine says, if these treatments weren't effective they would not have survived. Which would you rather have?

FDA: Americans Need More Drugs

The Food & Drug Administration (FDA) apparently believes that Americans are taking enough prescription drugs. After all, our country has only 4.3% of the world's population but consumes 48% of the world's prescription drugs ... but that's not enough. Now the FDA wants to allow drug companies to promote off-label uses of their drugs to doctors so more prescriptions can be written.

It's not like this is a new subject because off-label uses are already an estimated 21% of drug sales. Drug manufacturers want even more because it can mean additional sales ... lots of additional sales. For example, Risperdal was used off-label 66% of the time according to the Archives of Internal Medicine study from 2006. Anybody think this isn't about the money?

It's a complicated issue because drug manufacturers sued the agency in the 1990's for violating their freedom of speech. The Justice Department has been involved with a number of high-profile whistleblower lawsuits for off-label promotion so there's strong desire by the drug companies to get the situation nailed down ... to their advantage.

Drugs With One Small Side Effect - DEATH

The Food & Drug Administration (FDA) has finally decided it may be time to study another minor side effect of many drugs - Suicide. After decades of ignoring problems the FDA has started requiring drug manufacturers to study whether patients become suicidal during drug clinical trials.

Following the discovery four years ago that antidepressants for children caused suicide the agency finally began to notice that drugs for obesity, acne, high colesterol, heartburn, insomnia and many other conditions also had this little problem. One of the most recent drugs to be caught with this side effect is Chantix which is used to stop smoking. Unfortunately these problems are noticed after the drug has been approved by the FDA and used by millions of people. Lives continue to be lost because of the rush to make money money by drug manufacturers and the ineffectiveness of the FDA to protect Americans.

What's sad and ironic is that these are the folks who don't want you to have the freedom to choose complementary and alternative medicine because it's too dangerous!