Latest Drugwonks' Blog
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.
Dan Carpenter, in the October 18, 2005 issue of Health Affairs, proposes financing post-marketing drug safety studies by augmenting FDA user fees. That’s just PDUFy. Why add (by Carpenteré¾ own calculation) 25% increased cost to the process when a more expeditious route is to empower FDA with the enforcement authority required to compel post-market commitments made during the initial approval process. Carpenter’s modest proposal would certainly provide a lot of work for idle academics, but not much in the way of enhanced patient safety. Maybe its time that we kept our powder dry and kept sponsors to their NDA-phrase promises. For more thoughts on the Carpenter article, please click on “comments” below for a thoughtful response from Bob Goldberg of the Manhattan Institute.
Senator Charles Schumer (R, NY) weighs in on the Tamiflu issue with the following perspective; “The problem is not the expense of the drug but rather the shortage of supply, which would immediately be rectified if other companies were able to produce it.” Well, kind of. “If” only it were as simple as gearing up mass production of Tamiflu the problem would indeed be helped, if not “immediately rectified.” But, unfortunately, it’s not so simple. Mark Twain said that for every complicated problem there is usually a simple solution — and it’s usually wrong. And Tamiflu production is extraordinarily complicated. We’re not talking about a toaster that can be mass-produced by anyone, anywhere in the world at any time. The Senator went on to say that the manufacturer of the drug, Roche, should be compensated fairly for giving up its rights over the drug. “I deeply respect the investment Roche has made in order to bring Tamiflu to market, but am confident that there is a way to both serve the public need and ensure that your company receives compensation,” he said in a letter to the company. Glad to hear that a well-respected United States Senator respects intellectual property rights. That’s a good point of departure. I wish the same could be said for rogue Indian patent thieves, the World Health Organization, and the Secretary-General of the United Nations.
Representatives Waxman and Slaughter just announced their co-sponsorship of HR 839, the “Restore Scientific Integrity to Federal Research & Policymaking Act.” Now, while I certainly object to the “restore” bit — I do agree with much of the verbiage, to wit: “Appointments to scientific advisory committees shall be made without regard to political affiliation, unless required by federal statute.” Also, that federal agencies would be required to ensure that “no individual appointed to serve on a federal advisory has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the agency determines that the conflict is unavoidable.” During my tenure at the FDA I was the senior official in charge of advisory committees and I’m here to tell you that what Henry and Louise are advocating is already status quo ante Grassley. But there is one conflict that I need to make known — my wife and Representative Slaughter’s daughter roomed together in college.
It is time to take off the gloves and prosecute stupidity. Looking at it from a different, more proactive angle, it’s time for tort reform. After all, as Forrest Gump so aptly put it, “stupid is as stupid does.”
Our courts are over-crowded and under-funded. Auto insurance and professional liability rates are too high. And, unfortunately, our personal responsibility levels are too low. A New York man sued McDonald’s, Burger King, Wendy’s, and Kentucky Fried Chicken for contributing to both his obesity and his related health problems. I wonder if he took Vioxx?
The man may be fat, but his attorney is a fathead, a very wealthy fathead. If we are going to prosecute stupidity, we will have to make it a misdemeanor (since our courts and jails are already over-burdened), but let us make enabling it a felony.
Keeping in mind the immortal words of former congressman and convicted felon James Trafficant, “Beam me up, Scotty,” consider this editorial from the 10/16/05 edition of the Business Review of Western Michigan:
Contraindicative Rx
If some state lawmakers have their way, drug makers in Michigan will lose their shield against consumer lawsuits. That’s a tough pill to swallow. The bills, which last month passed the House on an 89-17 vote, would repeal a 1996 state law that protects drug makers from liability if their products meet U.S. Food and Drug Administration safety and labeling standards. The bills’ Democratic sponsors are emboldened by last month’s Texas jury verdict against Merck and Co., which marketed the pain killer Vioxx. The jury awarded the widow of a Vioxx user $253.4 million. But here’s one fact to remember: The Michigan protection does not apply if a company intentionally withholds information or makes misrepresentations to federal regulators. While we worry that a lawsuit shield prevents a drug’s users from seeking every angle of recourse against a company that brings to market a drug with unintended ill consequences, the process of researching, developing and receiving approval to market a drug takes several years. What Michigan may do while trying to provide recourse for consumers is erode business protections against meritless lawsuits. What’s more, eliminating the drug-company immunity sends the wrong message as the state seeks to keep what remains of Pfizer’s facilities in western Michigan and elsewhere in the state and attract investments from life-sciences companies — a topic that came up in Business Review’s May 25 quarterly forum in Kalamazoo and Sept. 14 forum in Grand Rapids. After all, life sciences is a logical extension for protection. “We’ve got to protect the rights of consumers and make sure people who are negligent, and wantonly negligent, are punished,” state Rep. Bill Huizenga, (R, Holland),told Business Review. “On the flip side of that, we need to make sure companies are able to be innovative.” Huizenga, chairman of the House Commerce Committee, said removing immunity tells the pharmaceutical industry — and life sciences, too, we say — that Michigan business law is going backward. Here’s our prescription for lawmakers — take a dose of reality, give it a rest and call us in the morning.
Frivolous lawsuits do nothing to educate the American public about better health care. In fact, they trivialize such important efforts. What’s most disturbing, however, are the effects such lawsuits have on our diminishing view of personal responsibility and warped perspective on blame. Blame is what people do when they find themselves on the wrong end of the risk/reward equation. Blame supposes fault and as Plutarch wrote, “to find a fault is easy, to do better may be difficult.”
If we do not stand up for what’s right and what’s needed, then we will live to see a thousand Michigan’s bloom.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
