GlaxoSmithKline Fine

How can I resist mentioning that GlaxoSmithKline has agreed to pay a $750 million fine to settle their civil and criminal cases resulting from a whistle-blower who exposed their quality problems in Puerto Rico.

The cases involved 20 drugs with questionable safety or effectiveness. The list includes the drug Paxil, an ineffective antidepressant, Bactroban, an ointment and Avandia, a diabetes drug with a troubled history. The United States Justice Department said the $150 million payment to settle criminal charges was the largest ever paid by a drug manufacturer in this situation.

The only good news in the deal? The whistle-blower, a quality manager fired by Glaxo for raising the quality issues, will receive $96 million.

The bad news? Following Pfizer's four whistle-blower lawsuits since 2002 and record $2.4 billion fine last year, these cases don't even raise an eyebrow on Wall Street any more.

Prescription Drug Use Grows

A new government survey shows prescription drug use continues to increase in America. The report which covers through 2008 says that 48% of all Americans take prescription drugs now. The number of people taking 2 or more drugs grew to 31% but the biggest jump was in people taking 5 or more prescription drugs, nearly doubling from 6% to 11% in 2008.

Who says TV advertising doesn't work? It's sure worth the money when it comes to pushing prescription drugs!

Personally, I'm really getting tired of seeing at least one drug ad in every TV break at night, sometimes more than one. When is America going to realize there's a reason we're one of the very few countries in the world that allows this type of direct-to-consumer advertising?

Given the cost of these drugs is it any wonder why so many folks are turning to complementary and alternative medicine now?

Drug Industry Tactics

Last week one of my favorite shows (Leverage) featured a bad guy CEO at a pharmaceutical company. When he was told by one of the Leverage team that the FDA fined another pharmaceutical company over $2 billion for a bad drug he replied that they made $16 billion in profits so the fine only amounted to about 15%. He added "that's like tipping your waiter."

This week we read the news that the risks of Avania have been known and hidden by the manufacturer from the FDA and the public since 1999. When I read that GlaxoSmithKline had agreed to pay $460 million to resolve the majority of lawsuits they face I was reminded of the TV show. Sales for all drugs containing Avandia in 2008 alone were $1.5 billion.

Apparently GSK is willing to "tip the waiter" for selling Avandia.

And the pharmaceutical industry wonders why the public is suspicious of their drugs?

Drug Costs Jump

The headline on the front page of today's Dallas Morning News says it all: "Drug Costs Rise At Fastest Rate In Years." While the Consumer Price Index has fallen 1.3% in the past year the wholesale price of prescription drugs has gone up by 9%. This will bring the bill for drugs to about $300 billion this year. This is the fastest rate since 1992 but this time it's happening when the drug companies pledged to reduce costs by $8 billion a year after health care reform is in effect.

Does it look like a phony deal to you? The drug companies crank up sales by $10 billion in order to offer a price cut of $8 billion? I won't even go into the latest studies on heart drugs that show how they actually increase the risk of heart attack.

It's time for Americans to find better answers to their health problems than prescription drugs.

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?

Two States Restrict Gifts to Doctors

New laws taking effect this week in Massachusetts and Vermont ban or heavily restrict gifts from drug companies to doctors. The radio industry had payola scandals decades ago but the medical profession seems unable to restrict its appetite for money and gifts so lawmakers have stepped in. What's sad is that it's only in 2 states.

If doctors aren't embarrassed by all of these gifts why don't they simply put a big poster up in their waiting rooms and a special page on their website so patients can make informed decisions about their health care. After all, do you want a doctor doing your knee replacement who's taken $1,000,000 from a particular device manufacturer or one who has accepted no payments to bias his use of the best products for your care?

Let's be honest, the drug companies wouldn't be spending tens of millions of dollars on these "gifts" (regular folks would call them bribes) unless they increased sales and profits. Doctors claiming to be above being influenced are simply kidding themselves and their profession. The drug companies start the addiction with gifts while they're in medical school and it just gets worse over time.

But perhaps we should take a different approach. In NASCAR they proudly display their sponsors. The biggest sponsors get the biggest decals in the best position on the race car. Maybe doctors should admit they're being sponsored and put patches for each of the drug company products on their white lab coats. The biggest payments earn the biggest patches and best locations. At least then patients would know what to expect.

Vermont Drug Disclosure

Vermont is one of the very few states in the nation with a disclosure law that lets us get a look at how the pharmaceutical industry buys control of medicine today. The drug marketing disclosure law doesn't even include free samples but it's a snapshot of how the current medical system works.

In tiny little Vermont the top 78 drug makers reported spending a total of $2,935,248 to promote their products. Can you imagine how much the drug industry is spending in New York or California to promote drug use and their sales and profits?

And you wonder why the first suggestion from your doctor is about a drug?

How can complementary and alternative therapies compete in this game that's all about money instead of being about patient health?

Supreme Court: Drug Makers Can Be Sued

The pharmaceutical industry received bad news from the Supreme Court this week - they can be sued after all, even if their drug is FDA approved. Reversing a Bush Administratio policy the court ruled 6-3 to uphold the rights of Americans to sue manufacturers if they're harmed by a defective product.

Justice John Paul Stevens wrote that lawsuits "uncover drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly."

FDA Approves Genetically Altered Drug

The Food and Drug Administration (FDA) made history today when it approved the first drug made with materials from genetically engineered animals. This decision opens a new Pandora's box of treatments from the pharmaceutical industry.

The government approved the drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.

The biggest problem is that the FDA does not require any labeling to warn patients that this product comes from genetically engineered animals, once again protecting the profits of the drug companies.

Medicare's Cancer Drug Expansion

Last November Medicare expanded "off label" drug uses to treat cancer by expanding from one to four guides that can be used to authorize coverage. Critics say the drug guides aren't always supported by research and could be influenced by ties to the companies manufacturing the drugs.

As an example, one of the four designated guides is published by the National Comprehensive Cancer Network, a group of hospitals. The guide relies on panels of experts to review drugs, half of whom have financial ties with a cancer drug maker.

While it's compassionate to try and help cancer patients afford drug treatments the profit motive of the drug companies would seem to be the real reason behind this change and yet the latest illustration of their influence in Washington.

Wall Street Journal Opinion Article

Today's Wall Street Journal (Friday, Jan. 9, 2009) has a response by Dr. Deepak Chopra, Dr. Andrew Weil and Dr. Dean Ornish titled "Alternative Medicine Is Mainstream" which is filled with facts and common sense. I highly recommend you read it so you can better respond to the anti-CAM hysteria in the country.

Drug Industry Shift

According to the Washington Post the drug industry is adopting an "if you can't beat them, join them" attitude towards health care reform. With Democrats taking control of White House and Congress the pharmaceutical industry is about to begin a $10 million advertising campaign supporting universal health coverage.

First they give up the ability to give out free pens and office supplies to doctors, now supporting universal health coverage ... where will all of these changes end?

Hopefully they'll end with Americans consuming less than 48% of the world's prescription drugs! With only 4.3% of the world's population it's absolutely crazy we spend so much on drugs only to rank #40 in the world for longevity.

Follow the Money in Medicine

Congress and the Justice Department are looking into the payments made by medical device companies to doctors who consult for them. A bill is pending that would require companies to disclose payments by both drug and device companies.

In Texas, meanwhile, two renowned psychiatrists liked to the University of Texas system are being investigated for their connections to drug companies by U.S. Senator Charles Grassley (R-IA). The University of Texas is also investigating possible failures to report income and other financial allegations. The doctors are recognized for their contributions to child pharmacology.

Eli Lilly plans to begin reporting payments they make to doctors for advice and speeches, even making the information available to the public through an Internet database. It was also the first company to publicly report its educational grants for medical conferences noting that letting the public see what's going on is a necessary step towards restoring trust.

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?

Slow Enforcement of Off-Label Drug Use

Even after federal investigators find a drug company selling products for uses that are not approved by the FDA it can take up to 7 months for them to issue a warning. Then it can take the drug companies another 4 months to stop the practice. Yes, you're right in thinking that millions of prescriptions can be written in that amount of time resulting in lots of profits for drug companies.

As always, it's all about the money when talking about the drug industry, and it's never enough.

Drug Industry Control of Government

How much fun is the drug industry having with the current administration and climate in Washington? Would you believe they increased their lobbying spending by 32% in 2007? The pharmaceutical industry's spending has skyrocketed since Democrats took control of Congress to $168 million and it comes as no surprise that for the first time they gave more to Democrats than Republicans.

The biggest single spender was the industry's hub group, the Pharmaceutical Research and Manufacturers Board which paid $23 million. Their goal is to block the importation of inexpensive foreign drugs and to protect their patents. They're also doing everything they can to slow the growth of generics.

So next time you're spending $10 Oor more) per pill just remember who to thank!

With this kind of financial power is it any wonder that the field of complementary and alternative medicine is under more legislative attacks than ever before? Remember it was only 20 years ago that the federal courts had to protect chiropractors from the attacks of the American Medical Association. They've got the gold, and they're making the rules in Washington and in state capitals all across America.