Our Views

Product safety issues for 10 percent of Big Pharma’s total prescription market were among several factors leading to significantly lower- than-expected sales last year.

Although Big Pharma experienced a 3.8 percent sales growth in 2007, representing $286.5 billion in prescription drug sales, the rate of growth was down from 8 percent in 2006, and marks the lowest growth rate since 1961. According to a report from pharmaceutical marketing consultants IMS Health, product safety issues were among the reasons causing the slump.

IMS attributed the drop in sales to these primary factors:

• Loss of exclusivity of branded drugs to generics, which now hold nearly 68 percent of the market
• The fewest new, innovative drugs approved in 3 decades (and slowed physician adoption of new medicines, too)
• Slowing of Medicare Part D prescription drug business as that program matures
• The repercussion from mounting drug safety issues

Safety issues included a significant number of “black box” label warnings, as well as a number of important product withdrawals. The FDA also raised safety concerns about other products in the erythropoietins, diabetes and antidepressant therapy classes. Overall, says the IMS report, safety issues contributed to “significantly lower- than-expected sales, accounting for approximately 10 percent of the total prescription market.”

In his great blog, Eye On FDA, Mark Senak poses some interesting questions about the situation, suggesting that if the drop in product approvals isn’t because of the FDA’s backlog (which are due at least in part to staffing shortages), it could be increased concern over product safety:

“One can truly see one of the many impacts of the fact that the agency has issued more approvable letters in 2007, to a degree shutting down the pipeline, impacting the market, patients and stockholders. This of course, leads to the question whether or not this is a product of (i) a risk averse environment, or (ii) products have suddenly gotten bad, or (iii) the FDA has purposely slowed things down so that it can catch up.”

(“Approvable letters” are notices to drug makers that new products can’t be approved until additional actions are taken, usually in the area of more studies and testing.)

My thoughts are plainly this: Anything the FDA wants to do to beef up and improve testing before approving new drugs is okay with me. And I’m sure with the American public too, who are fed up with all the injuries, deaths and massive lawsuits stemming from incomplete, shoddy and even unethical testing and reporting — not to mention unethical marketing — that for too long has put the protection of profits and investor confidence ahead of consumer protection and confidence.

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One new development in Washington this week clearly shows that we’re not alone in our call for Big Pharma reforms.

Republican Sens. Chuck Grassley and Herb Kohl have introduced a bill that requires drug and medical device makers to report to the federal government the value of free services, and almost every penny, they provide to doctors. Anything over $25 would have to be reported quarterly and would be posted on a government website for all to see.

For several months, Congress has been looking into the millions of dollars that flow from Big Pharma (and smaller pharmaceutical makers too) to America’s physicians, for everything from speaking engagements and consulting fees to golf weekends, travel and free meals.

There is some question about how, or even if, this practice influences what drugs doctors prescribe, because this seriously affects health care costs. The price of a cheap generic vs. an expensive brand drug, times the billions of prescriptions written every year, makes a huge difference in the health care bottom line.

In our view, there’s absolutely no doubt that Big Pharma’s physician bribery program sways prescribing practices. If it wasn’t working, Big Pharma wouldn’t keep on shelling out the millions of dollars to doctors. According to reports, some individual doctors have actually been paid hundreds of thousands a year in such gifts or fees-for-services.

The practice also raises the fear of potential patient harm from being prescribed drugs they might not need, or that may not be exactly what is needed.

Said Sen. Kohl, the bill’s co-sponsor, “At our June hearing, the pharmaceutical industry told the Aging Committee that they believe their practices are above-board. If that is the case, full disclosure will only serve to prove them right. If that is not the case, full disclosure will bring their influence-peddling out from the shadows. Either way, patients win.”

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When you think you’re near death in an ambulance rocking through the midnight streets with sirens wailing and the paramedics are trying to save your sorry ass, you are likely to suspend at least for the moment any problems you might have with Big Pharma

Some years ago I unexpectedly found myself – well, who ever expects it – on a gurney in a big red ambulance rushing through late-night rain-slicked city streets, possibly dying of a heart attack. As we careened around corners, sirens wailing, a couple of calm and earnest paramedics were putting an oxygen mask over my nose and mouth, attaching wires to my chest, and sticking needles in my arm.

I remember thinking briefly about how I was a devout believer in the evils of Big Pharma and that no mysterious chemicals would ever be allowed into my veins. Let me tell you, my friends, that was a very brief and fleeting thought. The choice between meeting my Maker and taking a flyer with Big Pharma was a no-contest.

In the years since that traumatic midnight ambulance experience, Big Pharma has come to personify more than ever the ultimate in corporate greed and ethical expedience – that means ethics flexibly convenient for the situation. Reams of media exposure about overt scientific fraud, misinformation and illegal marketing abuses, safety scares and recalls, thousands of injuries and deaths, and massive law suits have solidified that view.

Governmental and regulatory collusion to subvert the market and prevent consumer litigation has only accelerated distrust of our lawmakers. Imagine your wife, husband or child turned into a blood-thirsty zombie by some badly-tested and ill-approved pharmaceutical, only to discover that you’re legally prevented from seeking justice in a court of law. That’s not a situation we want to face.

Even the peer-reviewed scientific literature can no longer be fully trusted. Major medical mags have continued to publish test results that were either flawed or outright tampered with to make so-so drugs look better than they are or to hide seriously dangerous side effects.

The media has jumped on the bandwagon too. Major magazine stories, newspaper articles, radio and television shows, even popular films such as The Constant Gardener and Michael Moore’s Sicko, have only pounded Big Pharma’s tarnished reputation even more.

Big Pharma, which began in antiquity as our shamans, our gurus, our feared and respected witch doctors and healers – those who possessed mysterious knowledge about the substances that can alter and heal our bodies and minds – is no longer the respected provider of all that is life-saving, life-affirming – and even life-taking when considered necessary.

Big Pharma has morphed from ultimate healer to ultimate destroyer, a role never imagined by the first Australopithecus who stooped to taste a handful of wild berries and, head spinning, perceived all the wonderful possibilities.

What is needed now is a full examination of the disease that has brought Big Pharma to its knees, a condition for which there is no quick fix from a potion or pill. We need an official investigation of all concerned – lawmakers, regulators, drug testers and Big Pharma itself – one that will lead us to recommendations for saving this industry from melt-down, and help prevent future public drug disasters too.

The investigation should look at two main areas:

1.    An overhaul of common procedural practices for drug testing performance, reporting and approvals, to remove any possibility of the substandard results we are unquestionably suffering from now;

2.    A ramp-up of enforcement of all the codes of ethical conduct governing business and government, important beyond measure for an industry that holds the power of life and death in its hands – and that’s not some catchy slogan, folks, that’s our lives and our deaths, yours and mine.

With such a plan of action, perhaps we can return to this once-vital industry the productivity and continued expansion it needs to sustain research and develop safer and even more effective and life-saving new drugs, while weaning out and discarding those that are only marginally helpful, unhelpful and outright dangerous.

And like those incredible paramedics years ago on my first ambulance ride, along with the ER nurses and doctors who later toiled solely and selflessly on my behalf – maybe Big Pharma can recover the support and respect that any dedicated life-saving activity truly deserves.

In our activity of providing medical drug detox services, we have seen a major shift from illicit street drugs to prescription drugs from Big Pharma. I invite you to share your comments, ideas and experiences with or about Big Pharma and your prescriptions.

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