Latest Drugwonks' Blog
New data from IMS Health projects that prescription drug sales will “soar” in the United States next year, fueled in part by a $400 billion expansion of the nation’s Medicare program. IMS forecasts that the U.S. drug market, which already accounts for 43 percent of global pharmaceutical sales, is projected to grow between 8 percent and 9 percent in 2006. Not surprisingly, the media stories have neglected to mention why — or why this is a good thing for the future of the American consumer and the American health care system. The answer is simple — and simply crucial to the macro debate: people with prescription drug coverage use more medicines than those without. Ergo, more people covered equals more medicines sold. Common sense, right? And they’re being sold for the right purpose, because prescription drugs are not an impulse purchase. Despite what politicians, pundits, and so-called advocates would like you to believe, poll after poll of physicians shows again and again that doctors are not prescribing medicines at the request of advertising-bedazzled patients. That is just not true. Period. Docs are prescribing medicines because their patients have conditions that call for pharmaceutical intervention. But the media reports of the IMS data don’t mention any of this and would lead you to believe the opposite. All the reporters seem to be interested in is volume and costs — making it a political rather than a public health story. But, alas, they fail to put either volume or cost into the proper perspective. Nowhere do they explain the underlying rationale that it is far cheaper to treat a chronic condition such as hypertension or diabetes than to pay for the acute manifestations of these diseases (heart attacks, strokes, amputations, etc.) And how do you keep a chronic condition from becoming acute? That’s right, through appropriate use of … medication. That’s the raison d’etre of Medicare Modernization. More drugs, appropriately prescribed and used as directed lower health care costs. And that’s the rest of the story.
Bob Goldberg’s latest …
Yesterday, the House of Representatives took the bold
and courageous step of limiting the amount of money
you and I will get from the federal government to pay
for converter boxes that will allow us to switch our
televisions to digital.
In other words, while the GOP decided to spend only
$1 billion which includes several hundred million for
“education (maybe a government toll free number to
walk people through installation and how to use Tivo)
the Dems wanted to spend $4 billion for every
household in the universe. Congressman John Dingell
railed against GOP heartlessness and asserted the $40
cost of the box was a TV tax against the working
My guess is that most Americans will pocket the money
and spend it on the low cost digital TVs that will
flood Wal-Mart, Costco, etc over the next three years,
which will be on top of the converter rebates cable
companies will offer.
The idea that tax dollars would go to subsidize TV
purchases is almost mind numbing particularly in light
of the fact that the same Congress is hell bent on
saving money on prescription drugs by limiting access
to the newest drugs, destroying generic competition
and slapping price controls on what’s left.
(See my latest rant at
In otherwords, Congress will spend $4 billion so
people can watch Desperate Housewives or the New York
Yankees in high definition (not a bad thing by
itself)but will reduce the amount it spends on better
and newer medicines. Which reminds me of what Mark
Twain once wrote: “G-d made idiots for practice. Then
he made Congress.”
Good news as reported in today’s WSJ article on the meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee — The Food and Drug Administration convened the panel (to discuss an agency proposal that drug makers submit “longer-term efficacy data” on drugs that are used to treat depression, bipolar disorder, schizophrenia and a range of other psychiatric illnesses before they are put on the market.) The panel voted 12-0 against a proposal to require premarket long-term efficacy data for drugs that would treat major depressive disorder. The panel didn’t vote on other psychiatric disorders, but said the FDA should consider each illness separately before implementing a “one-size-fits-all” policy for psychiatric drugs.
This deliberative dozen is helping to disprove the old maxim that “Sanity calms, but madness is more interesting.” If only the same were true in Congress and the media.
The AP reports today that, according to a new report by Express Scripts Inc., a pharmacy benefit manager, consumers, their employers and health plans in the commercial market could have saved more than $20 billion last year through increased use of generic drugs. Dr. Steve Miller, Express Scripts Vice President of Research, said that many people still don’t feel comfortable asking their doctor about generic alternatives to brand name drugs. Miller added that drug advertisements reinforce a brand’s name and image to the consumer. So why is the U.S. Congress trying to kill off “branded” generics? (Note blog entry from 10/25/05.) If, as most experts agree, people trust branded products and question the medicinal value of generics, shouldn’t we want more branded generics on the market? Hello? Pending legislation is going in the polar opposite direction. Rather than robbing Peter to pay Paul, perhaps our elected representatives (in this instance personified by Senator Charles Grassley and Congressman Joe Barton) should call for a more potent consumer education campaign on the safety and efficacy of generic drugs.
Celebrating the centenary of Einstein’s wonder year, we are once again faced with the immutable Theory of Medicare Relativism — when politics wins, patients lose. We are also, unfortunately, faced with the implications of the Special Theory of Medicare Relativism — price controls = choice controls. The most recent example of these dreaded theorems in action is brought to the American people through the proposals of Senator Charles Grassley and Congressman Joe Barton. If the honorable gentlemen get their way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during 180-day exclusivity to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.) The deliverable to the American patient? Higher prices and fewer choices. Needless to say, the Grassley/Barton “modest proposal” is being greedily embraced by the generics industry. And greedy is hardly hyperbole since profits on generic medicines exceed 45% even when there is a competitive branded generic on the market. This is what we get for Medicare modernization? It’s Voltaire’s famous aphorism come to life, “The art of medicine consists in amusing the patient while nature cures the disease.” It would be far better if Chairmen Grassley and Barton followed the advice of Professor Einstein who said, “Any intelligent fool can make things bigger, more complex, and more violent. It takes a touch of genius — and a lot of courage — to move in the opposite direction.” Step up to the plate, gentlemen.
Sidney Wolfe, Public Citizen’s General Secretary of Junk Science has just filed a Citizen’s Petition with the FDA calling for a Black Box warning on ED medications because of 48 events of NAION (non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible). To put this in perspective (something Public Citizen really prefers not to do), during that same period 89 million prescriptions were written just for the little blue pill. In July, FDA advised patients to stop taking the pills and call a doctor if they experience sudden or decreased vision loss in one or both eyes — and to tell their doctor if they have ever suffered an episode of sudden vision loss, because such patients are at increased risk of a second episode. A prudent move. But that’s not enough for Dr. Wolfe who says that the FDA “has once again failed in this responsibility. These drugs need much stronger warnings, especially a black box warning such as the one we have proposed.” Suggesting that Sidney have his eyes examined would only be a partial diagnosis.
The Senate has passed without debate and sent to the president legislation that ends Medicare and Medicaid payments for erectile dysfunction drugs. According to Senator Charles Grassley, “Taxpayers shouldn’t have to pay for certain lifestyle prescription drugs through Medicare and Medicaid.” That may anger enough senior citizens in Iowa to have them call for a special, four-hour election.
Tennessee Williams wrote that, “A vacuum is a hell of a lot better than some of the stuff that nature replaces it with.” My comments refer to the October 2005 issue of Nature. In the article, “Cash interests taint drug advice,” authors Rosie Taylor and Jim Giles accuse many of America’s top researchers and physicians of dishonesty and distortions because of financial ties to the pharmaceutical industry. This slander is based on their “investigation” that uncovered that — STOP THE PRESSES — many top thinkers work with drug companies. It’s a classic example of guilt by innuendo. Nowhere in the article, nowhere, do the authors cite a single instance, not one, of an inappropriate clinical guideline being drafted by conflicted experts or adopted by academy boards “stacked” with “influenced” panelists. Rather the authors spend their time “revealing” financial conflicts of interest. During my tenure at the FDA I was the senior official in charge of advisory committees. We vetted COI issues with severe diligence — and made sure that our decisions were all public. Just because a world-class expert works with industry does not make her persona non grata. We should all want top minds to help direct national medical decisions. And industry has chosen to work with many of those same individuals for a reason — they’re the best and the brightest. The authors do point out that too many conflicts are not disclosed — and that’s a mistake. Transparency is crucial to earning and retaining public trust. The article does make some good points, but mostly it’s garbage. To quote Woody Allen, “I am at two with Nature.”
From the pensive pen of Dr. Sally Pipes:
“We are not prepared for a pandemic,” Health and Human Services Secretary Michael Leavitt said earlier this month. We do, however, face a significant risk of being hit by one. A new strain of the avian flu, known as H5N1, has killed at least 60 people in Asia since 2003. So far, humans cannot pass it to one another — virtually everyone infected caught the virus from a diseased bird.
The risk to people is nevertheless grave. The 1918 Spanish flu epidemic, blamed for 50 million deaths, also started among birds, but it mutated and spread to humans. Scientists fear the same thing could happen now. As an expert epidemiologist recently told the Wall Street Journal, “Ité¾ not a question of if, but when.” The Centers for Disease Control (CDC) estimates that an avian-flu pandemic could kill between 89,000 and 207,000 Americans. There is no publicly available vaccine for the new strain.
Now that the threat is upon us, the administration says it plans to bolster vaccine production in the United States and purchase huge quantities of antiviral drugs. But the question is: Why weren’t we ready in the first place?
The United States once had a large vaccine industry. In 1957, 26 companies supplied the market for standard children’s vaccines — but now only four companies do. Three decades ago, at least 10 U.S. firms manufactured vaccines to treat seasonal flu. By the late 1990s only five remained. And in 2004, the entire U.S. flu-vaccine market depended on just two companies — a French firm with a factory in Pennsylvania, and a California firm with a factory in Great Britain. Hence, our sense of crisis during last year’s flu season, when contamination at the British plant curtailed supply.
The only avian-flu vaccine likely to be available soon is made by the French company Sanofi-Aventis — the same firm we rely on for seasonal flu vaccines. The Sanofi-Aventis vaccine against H5N1 is undergoing preliminary U.S. government testing and showing early signs of success, but it’s not clear how soon it could be available. California-based Chiron — the one with the contaminated British plant — says it will have an H5N1 vaccine ready for testing by the end of the year.
To develop new and better flu vaccines is well within the reach of science. So why don’t U.S. drug companies, which dominate the global medicine market, make vaccines?
First, vaccines are subject to excessively strict screening by the Food and Drug Administration (FDA). So, for example, FluMist, a flu vaccine delivered via nasal spray, has only been approved for use for people aged between five and 49. It is our youngest and oldest, however, who run the greatest risk of catching the flu. This means that the cost of researching and developing new vaccines is needlessly expensive.
Second, vaccines are very expensive to produce. Using one older method of making flu vaccine, it costs about $300 million to build a factory and takes almost five years to get it completed and inspected. The company that makes FluMist, Maryland-based MedImmune Inc., could produce 20 million doses a year, but only about two million would get by the regulators. Because flu vaccine doesn’t keep, in 2003 MedImmune was forced to discard four million doses of its product.
Third, out-of-control lawsuits have scared companies away from developing and producing vaccines. For example, a researcher claimed in the 1970s that the whooping-cough vaccine caused brain damage. More than 800 lawsuits were subsequently filed in the U.S. against vaccine makers. Scientists later proved conclusively that there was no link between the vaccine and brain damage, but by that time the manufacturers were already out of business.
If companies stood a chance of recouping their investments, all these high costs of doing business might be manageable. Government price controls, though, make getting a return next to impossible. The Vaccines for Children Program was the final nail in the coffin of the American vaccine industry. Established by the Clinton administration in 1994, it established a single-buyer system for children’s vaccines. The government now buys 57 percent of all childhood vaccines, forcing steep discounts on manufacturers.
In short, litigation, regulation, and price controls have strangled our ability to prevent deadly diseases, among them avian flu. It doesn’t have to be this way. America leads the world in making medicine. Pharmaceuticals created by U.S. firms have made our lives longer, more comfortable, and more productive in ways our forefathers couldn’t have imagined. People everywhere clamor for AIDS and cancer medications invented in the United States. If we remove the red tape that has choked off vaccine production, we could have a healthy vaccine industry too.
Here’s another (prepublication) paper. We’re not called DrugWONKS for nothing.