In a notice posted on the FDA’s Web site Friday, the agency said it is seeking comments on a proposed study that would examine whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. The agency said the study is part of an effort to get “empirical data about consumers’ perceptions” of coupons and how a particular product might be viewed. The agency said information from the study would be used “to justify future regulatory changes.” “Coupons and price promotions may imply superior drug efficacy,” the FDA said.

Well, here’s a cost-saving tip to my buds at DDMAC — coupons do, in fact, attract people to a product. That’s why they’re used. Whether or not an ethical product should coupon is certainly an interesting philosophical question.

But it is in no way a regulatory one.

Here’s Bob Goldberg’s perspective on another aspect of Marc Kaufman’s article …

So typical of the lazy and unsystematic thinking that plagues health care reporting in general. Worrying about generic drug backlog because it’s one of the few ways to reduce “skyrocketing” health care costs” (Actually, health care costs have been slowing in recent years but whose counting. Increased use of medicines is attributed by many scholars — i.e., not journalists — for the slowdown because use of medicines postpones or offsets utilization of surgery, nursing homes, etc.)

Now, how about the delay in the cervical cancer and rotavirus vaccines? The delay in the Alzheimer’s vaccine? The 10-year lag in figuring out that Herceptin should be used in early stage breast cancer because all the trial designs are geared to show maximum benefit from a frequentist statistical standpoint that has no reference to real world use? Taken together these products and uses alone would make the “savings” of the 800 generic medicines waiting at FDA seem a pittance. Has Kaufman ever done a piece on the need or effort to transform the FDA to accelerate the development of real health care solutions. No. You can look it up.

It’s another example of how the MSM fails to get the connection between health care costs and technology: the price of new technologies that are based on a geniune understanding of disease mechanisms and individual responses to treatment are cheap relative to the cost of managing the same illnesses with halfway or no tech approaches. Put another way: what is cheaper, what is more cost-effective: using generic versions of today’s drugs as part of the effort to treat more cases Alzheimer’s, cancer, stroke, diabetes using our current know-how, or treatments that actually prevent or stop these diseases before they develop?

Why do policymakers, pundits and journalists see the efforts and investments of companies pursuing these high tech solutions are evil but see the accelerated development of knock-offs as holy?

In The Washington Post, Marc Kaufman reports that the FDA has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.

FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers. “We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog,” said Gary Buehler, director of the agency’s Office of Generic Drugs.

That generic response is completely unacceptable. The Office of Generic Drugs needs more reviewers and that means it needs more money.

The days of saying “we can do more with less” are over at the FDA. Today, unfortunately, it’s about doing less with less. That is not acceptable.

The generics office’s budget was about $26 million last year. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises. Gary Buehler said he expects a record number of applications this year — and an even larger backlog — because “we don’t believe we’ll be getting any staff increases in 2006.” Buehler said his office received an all-time monthly high of 129 applications in December.

And he says he doesn’t need any more money?

“This huge backlog of generic applications is just unacceptable,” said Rep. Henry A. Waxman, one of the sponsors of the law that made generics more easily available two decades ago. “This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind.”

I never thought I’d be saying this, but Mr. Waxman is 100% right. But talk is cheap. The question is, what’s he going to do about it?

Henry — show me the money.

Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s — pay user fees to finance new hires by the FDA.

Considering the huge profits enjoyed by the generic drug industry, I think this is certainly something to consider.

Plan “B” for “Bob” (Goldberg) …

Fresh from rolling her eyes at the President at the SOTU, Hillary Clinton took direct aim at CMS director Mark McClellan about the what the media has now deemed “the troubled” Medicare prescription drug plan. In full campaign mode, Mrs. Clinton told Dr. McClellan during a hearing “I, for one, believe we should scrap this and start over.”

With what? Hillary didn’t say. But she’s still proud of her record so we can assume that Plan B is Hillarycare Redux. Indeed, after trashing McClellan she took the opportunity to take credit for drug prices going down when she was running the health care show. “We weren’t successful getting the legislation passed, but we were successful sending a message that people better get their prices down,” she said.

Maybe. But back then the market value of biotech stocks also went down. So too did the amount of venture capital flowing into start-ups. Indeed, the amount of money going into biotech declined more sharply when Hillary was threatening price controls than at any other time since biotech has been around. A survey of biotech firms at the time and found that 75 percent of them had 2 years of cash or left in large part because, as the head of the biotech trade group BIO testified at the time “1993 difficult year because in large part investors were scared by the de facto price controls in the Administration’s health care plan. They feared that some widely discussed points of health care reform would mean that they would not recoup their investment in a company that was close to bringing a product to market. According to many press accounts and three BIO surveys of our companies developing therapies for AIDS, cancer, and other deadly and costly diseases, our companies are cutting back on research.”

And the price controls she DID get passed in the Vaccines for Children Program were cited by the Institute of Medicine in 2001 as one reason the vaccine industry is stagnant and unprofitable. Who wants to invest in products knowing your prices are going to be frozen for a decade?

Then there’s Children’s Health Care Insurance Plan she loves to take credit for. This program provides federal money to set up state run low cost insurance programs for working class kids. It was supposed to insure nearly 9 million children. Guess what? Under her stewardship kids were first dumped from Medicaid and then re-enrolled into SCHIP programs. And then it took 4 years to enroll 3 million children. And at the same time, private companies dumped coverage for kids and many parents simply stopped insuring their kids at all.

This page will be more than happy to help Mrs. Clinton promote her health care ideas. Sunshine is the best disinfectant.

Here’s an e-mail that Michael Moore is sending around. (I’ve only included snippets — but you’ll get the idea.) It’s just another high profile example of the Propaganda of Fear, of finding horror stories and packaging them to look like the everyman status quo. The epitome of the one-sided argument. If this project ever sees the light of day, it will have an impact on some of our political leaders — because it’s precisely the kind of drivel they want to hear. It’s the 21st century version of bread and circuses.

That being said, it’s time that we begin our own crusade of good news, of communicating, through truth and hope, the miracles of modern medicine. We must fight the Propaganda of Fear with the Four Horsemen of Conviction, Confidence, Truth and Hope.

Here’s the less from Moore …

Have you ever found yourself getting ready to file for bankruptcy because you can’t pay your kid’s hospital bill, and then you say to yourself, “Boy, I sure would like to be in Michael Moore’s health care movie!”?

Or, after being turned down for the third time by your HMO for an operation they should be paying for, do you ever think to yourself, “Now THIS travesty should be in that ‘Sicko”movie!”?

Or maybe you’ve just been told that your father is going to have to just, well, die because he can” afford the drugs he needs to get better — and it’s then that you say, “Damn, what did I do with Michael Moore’s home number?”!

Send me a short, factual account of what has happened to you — and what IS happening to you right now if you have been unable to get the health care you need. Send it to michael@michaelmoore.com. I will read every single one of them (even if I can’t respond to or help everyone, I will be able to bring to light a few of your stories).

Thank you in advance for sharing them with me and trusting me to try and do something about a very corrupt system that simply has to go.

It’s time that we, the voices of reason and sanity and hope go on the offensive against people like this who, just to turn a buck, will ravage just about anything — including the miracles of modern medicine. Mr. Moore isn’t interested in making things better — but he’s sure interested in making money — the same charges he’s leveling against those in the crosshairs of his camera lens.

Long-term thinking at long last in European health policy? Maybe.

European governments seem to be swapping a bludgeon for a scalpel when it comes to cutting the cost of medicines. According to Reuters, drug makers should not expect an end to the overall drive to squeeze prices but there are signs of a more discriminating approach that may actually help “big pharma”, according to industry executives and analysts. Andrew Witty, head of European pharmaceuticals at GlaxoSmithKline Plc said a growing number of governments are now realizing that healthcare reforms must include rewards for innovation.

“There are still a few governments that are very focused on short-term, non-discriminatory cost measures, where they simply cut prices and they donç©° really care if it is an innovative product or an old one, but they are getting fewer,” he told Reuters. ‘There are more and more countries where we are seeing governments get much tougher on the prices of old, off-patent medicines and being prepared to reward meaningful innovation more quickly and more fully.” For companies like Glaxo, which relies heavily on sales of newer drugs, that is good news.

European pharmaceuticals growth is hovering around a 10-year low with sales in the top five markets — Germany, France, Britain, Italy and Spain — rising just 3% in the 12 months to November, according to IMS Health. Yet Merrill Lynch believes the worst effects of European pricing reforms may now be over, with Germany in particular showing signs of recovery. Growth in German pharmaceuticals has picked up to 7%, from 1% in 2004, largely as a result of a cut in mandatory manufacturer rebates to the government, the investment bank said in a report this month.

Here’s an unsolicited e-mail that I got today …

Dear Peter Pitts:

It’s a well-known fact that Consumer Reports provides expert advice
and unbiased information and Ratings. Each year, we report on
thousands of products — everything from cars to computers, tires
to treadmills.

But did you know … we also offer independent, trustworthy medical
advice and top treatment Ratings for over 100 common conditions,
including back pain, obesity, ADD, and breast cancer, among
many others?

INTRODUCING … Consumer Reports MedicalGuide.org.

This new, interactive Web site will empower you to take charge of
your healthcare. The assessments and ratings it provides are based on
the best evidence from clinical reports from around the world, in
partnership with the British Medical Journal. And because we don’t
accept advertising, not from drug companies or from insurers, we are
free to say what works, and more importantly, what doesn’t.

So, whether you’re researching an existing medical condition or
wondering what drugs adversely interact with your new prescription,
Consumer Reports MedicalGuide.org has the answers.

I will not be subscribing to this marvelous opportunity. You can draw your own conclusions.

Paul Krugman wrote an op-ed singing the praises of what he calls the socialistic health care system of the Department of Veterans Affairs. He was taking a page from a speech given by Hillary Clinton the week previous to his editorial in which she outlines a new vision of Clintoncare where government still runs the show but uses electronic patient records, price controls and government drug lists to make medicine more efficient. The following lengthy deconstruction by Bob Goldberg is must reading for anyone who wants to fully understand the manner in which Mrs. Clinton and others shround their effort to nationalize health care with deliberately misconstrued interpetations of obscure research publications they know journalists are too hurried to track down and seemingly erudite (but misinformed) discussions of the impact that market forces and medical technology have on the American health care system.

Here’s the link:

Download file

Here is a link to an important perspective on the FDA’s new physician labeling rule. It’s penned by AEI scholar and CMPI advisory board member Jack Calfee.

Download file

Big news that will surely generate big controvery …

The New York Times and other media report that the European Union’s drug regulator recommended approval on Friday of a generic version of a growth hormone, a step forward in attempts to get approval for copies of biotech drugs.

Regulators in the European Union and the United States have not yet approved any so-called biosimilar medicines amid fears over safety and pressure from makers of patented biotech drugs. One big concern is that biotech drugs, unlike traditional chemical compounds, are too complex to copy easily and safely.

The European Medicines Agency said that studies on Omnitrope, a growth hormone made by Sandoz, the generic arm of Novartis, showed comparable quality, safety and efficacy to Genotropin, a Pfizer drug already approved in Europe. The decision should pave the way for the European Commission, the European Union’s executive arm, to give formal approval to Omnitrope within a few months.

Europe issued guidelines for biosimilar medicines in 2004, laying out the steps needed for regulatory approval. That has made it easier to file than in 2003, when the European Commission declined to approve Omnitrope, said Andreas Rummelt, chief executive of Sandoz.

Oops. I made a mistake in yesterday’s blog entry (“Lack of Evidence-Based Accusations”). I referred to Dr. David J. Rothman as President of the Institute of Medicine. He is, in fact, President of the Institute on Medicine as a Profession. I have to admit that my initial reference came directly from the New York Times article on the JAMA editorial. (And I should know better than to take whatever appears in the New York Times as entirely fact-checked.) Mea culpa. (It’s like they say, everything you read in the paper is true, except for those things you know about personally.) What I find most interesting about this correction is that Dr. David Rothman isn’t even an MD — but he sure has strong opinions about who should be visiting their offices.

I also want to clarify my statement about the JAMA article’s lack of evidence. There certainly are plenty of citations — but not a jot about patient outcomes. How trivial! Further, the authors of the article view the visits of pharmaceutical sales reps as the only variable on a physician’s prescribing behavior. What about formulary restrictions? Or payment incentives? Or counter-detailing efforts, tiered co-pays or payor-switching? Details. Details. Details.

The concept that big, bad Pharma is to blame for everything isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue. Rather than trying to point a finger, the authors should pick up a mirror.

This week’s recommendation in the Journal of the American Medical Association (that all but eliminates any role for pharmaceutical or medical device companies in teaching doctors about their products) reveals a lot about the medical profession’s anxiety about the integrity of some of its members.

First, as Peter Pitts notes below, there is no published evidence that relationships between manufacturers and physicians harm patient care. I am not a physician, but I can read Dr. Wazana’s article as well as anyone else. In her literature review of pharmaceutical sales practices, previously published in the same journal, and relied upon by the authors of this week’s proposal, she concludes that “no study used patient outcome measures”. The “negative outcomes” that she measured included physicians developing a “positive attitude toward pharmaceutical representatives” as a result of an interaction. That’s hardly a scandalous endpoint!

The term “health industry” is also interesting: the authors include drug and medical device makers in this “industry”, but not physicians, even though they earn their livings in it too! There is also an assumption that “education” and “influence” are mutually exclusive, but this is absurd: one cannot educate without influencing. Undoubtedly, drug and device makers seek to influence physicians, but that does not mean that the influence is uneducational.

Of course, the biggest unasked question is: where will the money come from to conduct education, if the corporations are banned? One answer could be that the physicians, as a profession that enjoys a government-granted monopoly on prescribing, should levy the costs of education on themselves. However, I am not aware of any study estimating what the per capita levy to cover these costs would be. I also doubt that many physicians will be enthusiastic about this proposal, once they face the full costs of their continuing education.

Nor is it out of line to accept that manufacturers’ reps are the best source of information for that medicine or device. Because I seem to be fond of automobile analogies lately, let’s try another one. A friend of mine owns a Volvo. Volvo pays for the head mechanic to go back to Sweden for training at the Volvo factory every year or two. This gives her the confidence that the dealership will service her car optimally. Imagine a Volvo dealer who proclaimed that he never let Volvo reps on his lot, or allowed them to train his staff, and forbad all communications with the manufacturer. That would not give you confidence that this was the man from whom to buy a Volvo, would it?

I realize that this is not a perfect analogy, but it illustrates the importance of understanding that the socially optimal level of drug makers’ “influence” over physicians is certainly greater than zero.

Refs.:

Brennan, T.A., et al. 2006. “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers”. Journal of the American Medical Association 295(4):429-433.

Wazana, A. 2000. “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” Journal of the American Medical Association 283(3):373-380.

A few key paragraphs from an editorial in today’s Wall Street Journal on the new Physician-Labeling rule:

So you might think everyone would welcome the Food and Drug Administration’s latest initiative to tackle the problem by requiring simplified labels with the most important information prominently displayed. But not some Democrats on Capitol Hill, who are so dependent on their trial-lawyer donors that they are fighting to preserve the current climate of uncertainty and confusion.

“A typical abuse by the Bush Administration,” said Ted Kennedy after the announcement last week of the FDA’s new labeling rule. House Democrat Maurice Hinchey said the FDA had “gone to bat for the drug industry.” He is threatening legislative action. And of course the lawyer (er, “consumer”) advocates at Ralph Nader’s Public Citizen piled on.

If drug makers are going to be asked to simplify labels, it only makes sense for the FDA to reassure them that the sound science embodied in its labeling oversight will still be held to “pre-empt” contrary findings at lower levels of government.

The FDA’s reassertion of the pre-emption doctrine is really nothing new, as some recent cases demonstrate … In Dowhal v. SmithKline Beecham, a plaintiff argued that nicotine replacement products be required to warn that they might theoretically cause birth defects. But the FDA had already considered and denied requests for such a warning because it believed the known risks of a mother’s continued smoking to a fetus far outweigh the known risks of nicotine itself. Again, there was the possibility of the court issuing a ruling in direct contradiction of federal law, and again the FDA intervened.

It’s hard to think of a case that better illustrates the moral bankruptcy of the Kennedy-Hinchey-trial lawyer position here than Dowhal. The kind of labeling and litigation environment they are fighting to preserve would probably have the effect, among others, of more women continuing to smoke during pregnancy. Overwarning on medications can be as much of a risk to public health as underwarning.

Our only concern is that this latest assertion of the pre-emption doctrine may not be enough to rein in state courts that have ignored it before. Congress might also consider making the FDA’s supremacy in drug safety matters clearer in statute, lest the Vioxx cases and others do irreversible damage to a vital American industry. Or, if Congress doesn’t like pre-emption, it could always dissolve the FDA and leave the matter entirely to the tort system. What should be unacceptable is to leave companies, as now, subject to the double jeopardy of FDA approval followed by tort-law second guessing.

Well said!

U.S. District Judge Eldon Fallon of New Orleans, who is overseeing thousands of consolidated federal lawsuits over Vioxx, ruled that Merck could depose a current editor and former editor of the New England Journal of Medicine, which last month criticized drug maker Merck & Co. for withholding data from a published study on its withdrawn painkiller Vioxx.

The depositions are to center on a December editorial in the journal that said Merck concealed three heart attacks suffered by patients in a large study published in the journal in November 2000. Merck has said those heart attacks happened after the study’s cut-off date for side effects, but journal editors say such data is routinely added until a study’s publication.

“The court should prohibit Merck from engaging in these retaliatory tactics because they run afoul of the protection journalists enjoy under the First Amendment,” an attorney for the NEJM wrote in a motion seeking to block the subpoenas.

What happened to the NEJM’s call for full disclosure and transparency?

The Wall Street Journal reports on Pfizer’s battle against Chinese counterfeiters who make and ship copies of its medicines, such as Viagra™ and Lipitor™. The story shows how active Pfizer is in counteracting this activity (which I trust we all agree is harmful to human welfare). It also reports on other examples of counterfeiting, such as a Chinese copy of a General Motors automobile, which the Chinese government does not altogether appear committed to stamping out.

Now, I know that “friends don’t let friends drive Chevrolets”, as the bumper sticker on many a Ford or Toyota pick-up reads, but (all kidding aside), if the U.S. government decided to make it illegal for GM to manage how it manufactures and sells its cars worldwide, you would have no idea whether you were driving a real GM car or a Chinese knock-off with dodgy brakes, fatigued metal in the frame, and seat belts that were just stapled behind the fabric. Plus, GM would quickly learn that it doesn’t pay to invest in new automotive technology because the U.S. government would just let foreigners steal it. That’s why the U.S. government is supporting GM in its Chinese legal battles against these counterfeiters, according to the article.

On the other hand, if Chinese companies want to develop their own automotive brands and sell them to Americans, they are free to do so. In fact, in January 2005, Malcolm Bricklin, a well-known automotive entrepreneur who imported Yugos years ago, announced plans to import Chery cars, a major Chinese brand, to the U.S. starting in 2007. Far from preventing this international free trade, U.S. law will protect Chery’s trademark and patents just like it protects GM’s.

Now, I would guess that it is many times harder to ship fake cars into the U.S. than fake pills, but the same legal framework, incentives, and dangers arise. So, it does not make sense that some U.S. politicians, lately even California’s Governor Szchwarzenegger, have decided that they do not like international free trade that respects intellectual property and outlaws piracy, but prefer to allow counterfeiters send their fake pills into the U.S. unchecked, via what is disingenuously labeled “drug importation”.

Ref.:

Zamiska, N., & H.W. Tesoriero. 2006. “As Pfizer Battles Fakes in China, Nation’s Police Are Uneasy Allies,” Wall Street Journal, January 24: A1

Caremark, one of the nation’s largest pharmaceutical mail-order companies agreed to pay $500,000 to settle a state regulatory investigation into its practice of restocking unopened prescription drugs, Illinois officials confirmed Friday.

The developments come more than a year after Attorney General Lisa Madigan’s office had launched an investigation into whether Caremark routinely and illegally sold drugs that had been returned by other customers. That investigation is ongoing, sources close to the investigation said.

Illinois officials have said reselling prescription drugs is allowed under very limited circumstances, typically when the drugs have not left the supervision of trained medical staffers, because the products may be tampered with or damaged.

So here’s the question: Why is it illegal when Caremark does it, but not illegal when the same dangerous behavior is pro forma with the foreign Internet pharmacies so beloved by Illinois Governor “Wrong Way” Rod Blagojevich?

When is illegal not illegal? Unfortunately, it seems that the answer is “when it’s covenient.”

Here is the house editorial from today’s Washington Times …

New FDA rules

The Food and Drug Administration this week took sensible steps toward 21st-century medicine by requiring that prescription-drug package inserts be more readable and less threatening. Drug companies initially wanted to keep the current mumbo-jumbo of chemistry and legalese for fear of lawsuits.

But the FDA persisted, maintaining reasonably and courageously — particularly in this era when a single senator from Iowa knows he can spuriously trash the agency about heartworm medicine and get media coverage — that an FDA approval is not just a minimum standard of safety. It is an evaluation, based upon the best science available or the relative risks and benefits of each medicine. Failure to clearly convey both aspects of a medicine could “discourage appropriate use of a beneficial drug.” Further, the FDA signaled that the package insert is a temporary method for providing consumers and doctors information, in an era when new insights into the best use of medicines are now being revealed through the use of genetic tests and post-market studies analyzing genetic variations in drug response. (The labeling information will be updated daily for free at the National Library of Medicine at http://dailymed.nlm.nih.gov.)

Finally, the FDA makes clear that it will assert its authority defended vigorously by the Clinton administration and upheld by several circuit and appellate courts — as the ultimate authority about what makes a medicine safe and effective. Too often trial lawyers seeking to make a quick buck at the expense of an individual who unfortunately suffered from a side effect of a medicine has sought to second-guess both the judgment of the FDA and safety warnings in an effort to obtain significant damages. The FDA serves notice that if there is going to be any “individualized reevaluation of the risks and benefits of a product” it will be as a result of new scientific information.

The agency will oppose any lawsuit that contends a jury or state law somehow has a reservoir of superior medical knowledge or authority for imposing additional safety standards beyond those required under FDA regulations.

Critics will claim that the FDA is often misled and it takes lawsuits to set things right. Yet all the lawsuits, as well as the grandstanding efforts of New York Attorney General Elliot Spitzer against the makers of Paxil, were based on clinical trial data from the FDA itself and from studies that were widely available.

The new FDA labeling rule will make information widely available in real time and link it to the label if need be, shedding light and advancing public health.

The folks at the Henry J. Kaiser Foundation must be getting desperate if they need to purposely misinterpret me. Here’s what they said …

Letter to Congress From Schwarzenegger Could Spur Action on Prescription Drug Reimportation, Some Observers Say

A letter California Gov. Arnold Schwarzenegger (R) sent to Congress this month urging it to approve legislation legalizing the reimportation of medicines from abroad could lead to prescription drug legislation this year because of California’s “size and influence,” some experts say, the Christian Science Monitor reports. Peter Pitts — a former associate FDA commissioner and current vice president for health affairs at the public relations agency Manning, Selvage & Lee — said that Schwarzenegger’s letter is “really important” because it represents “an acknowledgement from the largest state (by population) in the Union that this issue is a federal one” that needs to be addressed by Congress and not at the state level. Schwarzenegger has vetoed four reimportation bills because he is “concerned that quick legislative fixes at the state level would be contrary to federal law and over-simplify the complex safety, trade, supply and pricing issues involved” (Wood, Christian Science Monitor, 1/18).

Boy is that reading the Christian Science Monitor with rose-colored glasses. The quote is accurate. I did say (and I do feel) that Governor Schwarzenegger’s statement that importation is a Federal issue is very important — but not because I support the idea of bringing in unsafe, unregulated, often counterfeit drugs — but rather because it sends a strong message to folks like Wrong-Way Rod Blagojevich and DC Comics Councilman David Catania that just because a state or local pol says foreign drugs are safe doesn’t make them so. That’s the FDA’s job. That’s what Arnold said. And that’s why it’s important.

Here’s a link to an article I penned in Sacramento’s Capitol Weekly. If I leave any room for doubt as to where I stand or what I think on this issue — please let me know.

Download file

I think that the people at Kaiser must have their pointy helmets on too tight.

The Wall Street Journal reports that an FDA reviewer has recommended against GlaxoSmithKline’s being allowed to sell its weight-loss drug, Xenical™, over-the-counter. The company wants to sell a less potent version of the prescription medicine. According to the reviewer, the resulting weight loss would be modest and “transient”. That is, “it would not afford any long-term benefit through a change in behavior….”. The drug also benefits blood pressure, lipids, and fasting glucose (according to the FDA).

I’m no scientist, but if the FDA is not going to allow a drug maker to sell an OTC obesity med until they identify a drug that can change people’s behavior, or reduce weight with zero chance of putting it on again, Americans will never have the range of choices they need to deal with their growing waistlines.

GlaxoSmithKline understands this. It plans to call the drug “Alli™”, as in, “allied” with diet and exercise. The marketing campaign will undoubtedly encourage people to use the drug along with lifestyle changes. What good would it do the company for people to take the pill, but not lose weight because they do not exercise or eat better? They will stop taking the pill and badmouth it to their friends.

The marketing campaign would surely also be more effective than government programs to combat obesity (as my colleague, Diana Ernst has addressed). Meanwhile, Americans have a plethora of dietary and herbal supplements targetted at obesity, but no OTC medical option.

Here is a better option: let the FDA recommend against OTC Alli™, but allow GlaxoSmithKline to sell it, including the FDA’s negative recommendation on the label. Then, let the patients decide.

Refs.:

Ernst, D. 2005. Obesity and the State: The Skinny on the War Against Fat, December (Health Policy Prescriptions). San Francisco, CA: Pacific Research Institute.

Dooren, J.C. 2006. “FDA Questions the Benefits of Over-the-Counter Xenical,” Wall Street Journal, January 20.

Professor Philip Romero of the University of Oregon, and economic advisor to former California Governor Pete Wilson, has just issued a damning report on the negative welfare consequences of normalizing the illegal diversion of prescription drugs into the U.S., as recently proposed by Governor Schwarzenegger. Basically, stripping away drug makers’ rights to enjoy the fruits of their own invention will deestroy investors’ willingness to risk their capital in California’s biotech industry. Up to 100,000 biotech jobs will be lost in the Golden State and $3 billion in economic growth. That’s a heck of a price to pay for a policy that won’t even result in lower-priced drugs in the long term!