Today, the 1st Circuit Court of Appeals issued a decision in IMS v. Ayotte, the case challenging New Hampshire’s Prescription Confidentiality Act, which prohibits the commercial use of prescriber data, including for pharmaceutical detailing. The Court unanimously upheld the law, finding that it did not violate the First Amendment. The opinion weighed in at a hefty 148 pages.

The Act sought to prohibit the practice of “datamining” for the purpose of pharmaceutical marketing: pharmacies sell doctors’ individual prescribing data (what drugs the doctors prescribed, when, and how often) to companies that aggregate such data. Those companies then sell prescribing “profiles” of individual physicians to drug companies, whose salespeople can then use that information to tailor the “pitch” that they use in marketing their drugs to those doctors. For instance, if a doctor has been prescribing a competitor’s drug, they might tailor the sales pitch to talk about why their drug is allegedly superior.

IMS Health, a company that collects and sells pharmacy data on doctors’ prescribing practices, sued the state of New Hampshire before the ink was barely dry on the law. They alleged that it violated their First Amendment rights. In April 2007, the U.S. District Court for the District of New Hampshire agreed, and struck down the law. The State of New Hampshire appealed the decision to the 1st Circuit Court of Appeals, which heard the appeal in January 2008.

Sean Fiil-Flynn, who represented PAL’s parent organization Community Catalyst, as well as AARP, National Legislative Association on Prescription Drug Prices, National Physicians Alliance, New Hampshire Medical Society, and Prescription Policy Choices in filing an amicus brief before the 1st Circuit, gave an excellent analysis of the decision and its ramifications:

The court unanimously upheld the New Hampshire law. The majority found that the act does not regulate speech, but rather regulates only the conduct of health information companies that aggregate and sell prescription records. The concurrence concluded that the Act does affect speech of pharmaceutical marketers, but the regulation is nonetheless justified by the state’s overriding interest in promoting cost containment in the pharmaceutical sector.

This is an important decision for data privacy advocates. The ramifications of giving companies a First Amendment right to sell data on all of our purchases, travel and activities would be staggering. The First Circuit ruled on the side of consumer privacy, admonishing that the First Amendment does not protect every exchange of information from traditional social and economic regulation. It refused to apply the First Amendment to the trading of prescription records for marketing purposes where “information itself has become a commodity.” The court explained that applying the First Amendment to such trade in prescription data “stretches the fabric of the First Amendment beyond any rational measure.”

The 148 pages of analysis exhaustively analyses the voluminous evidence amassed by New Hampshire demonstrating the negative effects on our health care system of allowing pharmaceutical marketers to use prescription record tracking to target their marketing efforts.

The court affirmed that states have a valid interest in regulating the use of prescription records to target marketing to doctors. The court found that the use of such information to identify doctors who prescribe lower cost drugs and target marketing campaigns at them has a demonstrable impact on pharmaceutical spending that states are not disempowered to respond to. Access to individualized prescription data also allows companies to target gifts, consultancies and other perks to their most favored physicians, in effect incorporating prescribers into the commission structure of their sales forces. These practices debase the medical profession and, the more the practices become public, break the chain of trust between doctor and patient.

Other resources:

• The 1st Circuit’s decision is here
• An Associated Press article on the decision is here: NH prescription privacy law upheld
• The 1st Circuit Amicus Curiae brief of Community Catalyst and others is here.
• The District Court Amicus Curiae brief of Prescription Access Litigation and others is here.
• See also what PostScript, the blog of our colleagues at The Prescription Project, had to say about the decision.

Back in April the PAL fortune teller made some bold predictions about GlaxoSmithKline’s (NYSE:GSK) new migraine drug Treximet. (’GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors“). Treximet is nothing more than a combination of Imitrex (sumatriptan, soon to be available as a generic) and naproxen sodium (commonly known as Aleve and available over-the-counter). Treximet is a perfect example of what we called a Goober Grape drug, which we described thusly:

What’s a Goober Grape Drug?

Goober Grape, for the (fortunately) uninitiated, is a appalling combination of peanut butter and jelly in a single jar….

So henceforth, a “Goober Grape Drug” refers to any combination drug that offers no additional clinical advantage and only the most ridiculously minimal increase in patient convenience. There are certainly conditions in which combination pills are important, in that reducing the number of pills to be taken increases patient compliance, but allergies sure as heck ain’t one of ‘em.

Neither, for that matter, are migraines. There’s no evidence that taking Imitrex and naproxen in a single pill (as Treximet) is any more effective than taking it in two separate pills, which is not surprising. Given that migraines are often excruciating, it’s absurd to think that someone in the midst of a migraine would take one pill, but not two, to relieve their suffering.

So was the PAL Fortune Teller correct?
As the PAL fortune teller gazed into the Pharma Crystal Ball, a prediction was made that “TV ads will appear in prime time singing the praises of this “new” treatment for migraines. People frolicking through fields of flowers may or may not appear.” Anyone who watched the recent presidential debates saw the new Treximet commercial. In case you missed it see for yourself, here it is. (Note: there are not, in fact, people frolicking through fields of flowers)

Notice that the ad only says that Treximet is “superior to Imitrex tablets at relieving migraine pain” – it does NOT say that Treximet is superior to Imitrex and naproxen taken together.

The PAL fortune teller also predicted that:

“Yet you can be sure that Treximet’s price will be similar to what Imitrex costs right now ($25 a pill) and there’s a good chance it will be more expensive, as new drugs typically are ($30 a pill? More? Who knows?).”

We were wrong on this one — at least for now. On drugstore.com, 9 pills of Imitrex cost $199.98, and 9 pills of Treximet cost $229.78. That’s about $25 a pill for Imitrex and about $22 a pill for Treximet. Wait a minute, that means Imitrex is more expensive than Treximet (right now). What gives?

As we reported back in April, generic versions of Imitrex will become available starting in late 2008 and into 2009, when Imitrex’s patent will expire. So over the next year, the price of Imitrex will go down, finally settling most likely, as most generics do, at 20-30% of the brand-name’s price. We predicted that the cost of taking generic Imitrex and over-the-counter Aleve would eventually be about $7.50.

So GSK needs to do as much as they can to get people to switch to Treximet before generic Imitrex becomes available. That means running ads on TV, having drug sales people promoting Treximet to doctors, aggressively distributing samples to physicians’ offices. And another way to encourage doctors and patients switching is to price Treximet below the price of Imitrex.

What remains to be seen is what will happen once generic Imitrex becomes available. Inevitably there will be:

1. Imitrex patients who switch to Treximet before the generic becomes available who choose to stay on Treximet
2. New patients who start on Treximet without ever having taken Imitrex
3. Imitrex patients who switch to Treximet before the generic becomes available who then switch to generic Imitrex,
4. Imitrex patients who don’t switch to Treximet who then switch to generic Imitrex, many of them automatically. This is probably the scenario that GSK most wants to avoid. Most states, and most health plans, have policies requiring “mandatory generic substitution,” that is, if a generic is available for your drug, you’ll get the generic, unless your doctor writes “Dispense as Written” or “No Substitution” on the prescription.

Categories #1 & #2 above are those most likely to remain Treximet Loyalists. It’s distinctly possible that GSK will gradually increase the price of Treximet over time, after the generic becomes available. I’m willing to guess that a lot will depend on how successful they’re initial advertising and promotion is in manufacturing a market for Treximet. It’ll be interesting to observe.

So: We were right about the Treximet ads, and wrong (at least for now) about Treximet’s price. In the end, the PAL Fortune Teller is batting .500. Which is more than we at PAL can say right now for our beloved Red Sox, who are down 2-1 in the ALCS.

The Boston Business Journal reports today, Bay State ranked worst for pharma sales and marketing:

A pharmaceutical trade group has rated Massachusetts the worst state in which to pursue sales and marketing for the industry, in part because of a new law restricting the activities of sales representatives.

The National Association of Pharmaceuticals Sales Representatives said the new law, intended to help contain health care costs, will act to limit research and product-development initiatives and hamper innovation.

As residents of the Bay State, we here at Prescription Access Litigation wonder what we did to deserve this honor.

Now, what horrific restrictions on “research and product-development initiatives” does the new law impose on the industry?

It requires all pharmaceutical companies to disclose payments they make to health care providers that exceed $50. It requires the state Department of Public Health to establish a statewide code of conduct on marketing and gifts to health care providers. And it creates an evidence-based outreach and education program for prescribers.

That’s it. It doesn’t ban anything, prohibit anything, restrict anything. All it does is require disclosure of gifts to doctors. THAT’s what makes Massachusetts the worst state to pursue pharmaceuticalsales and marketing?

The National Association of Pharmaceuticals Sales Representatives must have forgotten all about the $1 billion gift that the taxpayers of this “worst state” just dropped in their lap back in June, the Massachusetts Life Sciences Initiative:

Governor Patrick signing the Mass. Life Sciences Initiative bill

The $1 billion will go to improve the “life sciences” infrastructure in Massachusetts, including tax incentives, grants, fellowships and other programs to promote research and workforce development that will certainly be beneficial to many of the pharmaceutical and biotech companies doing business in the state.

Here the Mass Life Sciences Initiative legislation.

Here’s the text of the bill that imposed the $50 gift disclosure requirement.

Here’s what Health Care for All, a PAL coalition member and key supporter of the legislation, had to say back in September about pharma’s warning threat that drug and biotech companies would leave the state in response to the law:

Do you remember this phrase: “a direct and immediate devastating impact?” That’s from the full-page ad the biotech industry took out trying to convince the Governor to veto the comprehensive quality and cost bill, that included enforcement of the pharmaceutical and device industry’s own voluntary guidelines. You might also remember the letter from GlaxoSmithKline, threatening to leave the state if the law was passed.

Those of us that support the gift ban thought it was an empty threat at the time – particularly in light of the fact that the state had just pledged $1 billion to the industry.

And, it looks like we were right.

Monday, Governor Patrick will join Genzyme officials to open a $125 million science center, part of $250 million cell culture manufacturing facility. On Tuesday, UMass-Lowell will open its fully automated Massachusetts BioManufacturing Center facility. And last week, a study co-sponsored by the UMass Donahue Institute found that 85% of life sciences employers in the state actually plan to expand their in-state operations over the next two years.

But in NAPSR’s world, a modest disclosure requirement warrants a designation as the worst state in the nation, notwithstanding the $1 billion we just ponied up. Talk about ingratitude!

A major story broke today in the New York Times, Wall Street Journal and Boston Globeabout Pfizer’s (NYSE:PFE) alleged manipulation of studies of its epilepsy drug Neurontin:

See:

• Keith Winstein’s Suit Alleges Pfizer Spun Unfavorable Drug Studies in the WSJ
• Stephanie Saul’s Experts Conclude Pfizer Manipulated Studies in the NY Times).
• Liz Kowalczyk’s E-mails suggest Pfizer tried to suppress study on drug in the Globe

The studies examined whether Neurontin was effective for conditions other than epilepsy. As the NY Times article describes,

Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers.

Neurontin has been an extraordinarily profitable drug for Pfizer, and most of the prescriptions written for it were not for epilepsy, but were “off-label” (prescribed for a use not approved by the FDA). In 2004, Pfizer paid $430 million to settle a criminal and civil case brought by federal prosecutors that charged that Warner-Lambert, which Pfizer acquired in 2000, had illegally promoted Neurontin for “off label” purposes in the 90s.

That $430 million settlement reimbursed state and federal health care programs (like Medicaid) that had paid for off-label prescriptions of Neurontin, but did not compensate consumers or “third party payors” (health plans, union benefit funds and others) that had also paid for such prescriptions. A number of class action lawsuits were brought against Pfizer, and they were consolidated in the U.S. District Court for the District of Massachusetts. The ongoing lawsuit is In re Neurontin Marketing and Sales Practices Litigation, MDL #1629, Docket #04-10981.

That case has been pending for several years, with the parties exchanging documents and arguing before the Court about whether a national class of consumers and third party payors can be “certified,” which is the prerequisite to the case going forward as a class action.

The documents that were recently released were part of “expert reports” submitted by the lawyers for the plaintiffs in the case. The reports both contain and analyze documents from Pfizer about its alleged illegal offlabel promotion of Neurontin.

Now that the reports and documents have been filed with the Court, they are a matter of public record. We here at Prescription Access Litigation subscribe to the maxim that “sunlight is the best disinfectant.” We are posting these reports and documents in their entirety so that the public can see them for themselves. They paint an interesting picture.

• Revised Supplemental Declaration of Ilyas J. Rona Filed In Support Of Plaintiffs’ Renewed Motion For Class Certification – this document describes the Exhibits (expert reports and Pfizer documents) that were filed with the Court. (The descriptions below of the Exhibits are taken from this Declaration.)
• Exhibit A: Parke-Davis memorandum from the Neurontin Marketing Team to the Field Sales Colleagues dated November 30, 1998, ―designed to explain why the Neurontin articles are able to be distributed by territory sales managers.
• Exhibit B: A memorandum from Pat Woster, Chair of the Parke-Davis Central Nervous System Specialty Group, to Medical Liaisons and Associate Medical Directors dated May 16, 1999, listing ―Articles for Distribution relating to the indications that are in this case. For example, one article ―supports the use of gabapentin and pregabalin for treatment of neuropathic pain. Other articles concerned ―acute mania,‖ ―Neuropathic pain after anti-HIV gene therapy, and ―bipolar disorder.
• Exhibit C: CME Guidelines for the Distribution of Educational Materials relating to Parke-Davis CME initiative entitled ―Advances in the Preventative Treatment of Migraine. The guidelines recognize ―that perhaps the most powerful means of promotion is direct contact and encourage ―Parke-Davis sales representatives to participate in raising awareness by distributing copies of the information brochure to appropriate physicians in their areas
• Exhibit D: PFIZER_CGROGAN_0022377, which is a Pfizer email from Christine Grogan to Lance Tyler dated April 26, 2001. The email states: ―Our [Review Committee] has allowed [sales] rep distribution of CME program invitations if the accrediting body has sent a written request asking for such support/help.
• Exhibit E: A Pfizer document entitled ―Neurontin Action Plan – POA2 – 2004 relating to Pfizer’s goals, strategies and messages for 2004. Under strategies, the document states: ―No calls on Psychs!!!!
• Exhibit F: Declaration of Meredith Rosenthal: Estimate of Units Paid for by Neurontin Endpayers that Resulted from Alleged Fraudulent Marketing by Defendants dated August 11, 2008
• Exhibit G: Declaration of Raymond S. Hartman dated August 11, 2008
• Exhibit H: Expert Report of Kimberly P. McDonough dated: August 11, 2008
• Exhibit I: Expert Report of Nicholas P. Jewell, Ph.D. dated: July 29, 2008
• Exhibit J: Expert Report of David A. Kessler, M.D. dated July 31, 2008
• Exhibit K: Report on the Use of Neurontin for Bipolar and Other Mood Disorders prepared by Jeffrey S. Barkin, M.D. dated July 25, 2008.
• Exhibit L: Neurontin: Clinical pharmacologic opinion of Dr. Thomas L. Perry dated August 10, 2008. 14.
• Exhibit M: Report on gabapentin (Neurontin®) for migraine prophylaxis: evaluation of efficacy, effectiveness and marketing prepared by d. Douglas C. McCrory, M.D., M.H.Sc.
• Exhibit N: the Expert Report of John Abramson, MD dated: August 11, 2008
• Exhibit O: Expert report entitled “Reporting and other biases in studies of Neurontin for migraine, psychiatric/bipolar disorders, nociceptive pain, and neuropathic pain” prepared by Kay Dickersin, Ph.D., MA
• Exhibit P: the Consultant Report Prepared by: Brian Alldredge, PharmD
• Exhibit Q: A Pfizer memorandum from Hank McCrorie—the former Executive Vice President in charge of US Sales—to all sales representatives informing them that ―a number of decisions have been made relevant to the promotion and marketing of Neurontin…,including the instruction that ―Neurontin detailing responsibility will be limited only to the US RON sales force (approximately 150 representatives). RON representatives will call only on Neurologists for Neurontin.

Note: There is a separate class action lawsuit in Calfornia state court against Pfizer for the same alleged off-label marketing of Neurontin in California, brought by several members of Prescription Access Litigation’s coalition. To read more about that suit, and the underlying allegations (which are the same as in the Massachusetts case), go here.

The Prescription Access Litigation blog’s resident Advice Columnist, Ask Pharmie, has been on hiatus for a while — but now he’s back! Ask Pharmie answers readers’ questions about the pharmaceutical industry, drug marketing, drug pricing, and the like. Send him your questions! (Keep in mind, he does not answer medical or treatment questions, or render medical advice.)

So, reaching into Ask Pharmie’s mailbag, here’s our latest question:

Question: I recently switched from a brand name drug to a generic version to save money. Although the generic works just as well, the pill is a different color and shape from the brand-name. This is confusing. Why don’t the generic pills look the same as the brand name pills?

Answer:
Good question! After all, generic drugs are the same medicine as the brand-name – they have the same active ingredient, and the same effectiveness. So it stands to reason that the pill would look the same, right? Not necessarily.

When a brand-name drug first comes on the market, the manufacturer has a patent on the drug that prevents any other companies from making or selling that drug. However, when the patent expires or gets invalidated, generic drug companies can apply for FDA approval to sell identical generic versions of the drug.

Generic drugs are required to have the same active ingredient and to work the same as the brand name. But this does not also mean that generic drug companies can copy the appearance of brand name drugs. If the appearance, shape, name and/or color of the drug is trademarked, it cannot be copied. Trademarks are words, names and symbols used to identify goods from a particular manufacturer. Unlike patents, which last a maximum of 20 years, trademarks never expire. While many brand name drug companies have traditionally only trademarked the names of their drugs, there is a trend towards trademarking the appearance of the drug as well.

For example, Pfizer has trademarked both the name Viagra and the well-known blue diamond shape of the Viagra pill. AstraZeneca has trademarked not just the name Nexium, but also the phrase “Purple Pill” and the characteristic purple-with-yellow-stripes appearance of Nexium.

So why have drug companies started to trademark the appearance of their drugs? In the past several years, brand name drug companies have started to make the appearance of their pills part of their marketing campaigns. By making consumers associate a particular appearance of a pill with the medicine contained in the pill, the drug company builds what’s called a “brand identity.” This helps convince the consumer that the product is superior and builds what’s called “brand loyalty.”

Drug companies use this strategy to stand out from their competitors. They also use it to try to convince patients to keep paying for the more expensive brand-name version of the medicine when a generic version becomes available. They hope that the patient will equate the look of the pill with its effectiveness. A generic pill can look “drab” in comparison, to, say a colorful Nexium pill, with its bright purple and its yellow stripes. It is a testament to how effective drug company marketing has become that consumers even notice the color of their pills!

Unfortunately, this serves to confuse patients. For patients that take many medications, the shape and color of the pill can help them remember what it is and what it’s used for. If drug companies didn’t trademark the appearance of their pills, then generic drug companies could make their pills look the same as the brand-name. This would help patients remember what each of their medications is, and avoid potentially dangerous errors (such as taking a drug at the wrong time, taking too much of the drug, missing a dose, etc).

The main thing to remember is that the appearance of a drug has nothing to do with its effectiveness. By using the color and shape of a drug as a marketing tool, brand-name drug companies are trying to fool you into thinking that these things matter, and to trick you into using an expensive brand-name drug when a less expensive one (generic or a different brand-name drug in the same category) would work just as well.

One last thing to keep in mind: The same generic drug can be made by many different generic drug companies, and each of their pills may look different not just from the brand-name pill, but from each other. If your pharmacy changes which generic drug company it buys your medication from, or if you switch pharmacies, your pills might suddenly look different than they did the last time you filled your prescription. Don’t panic! This doesn’t mean that you got the wrong pills. But, if you are at all uncertain or concerned, talk to your pharmacist. Better safe than sorry.

Here’s links to the past Ask Pharmie columns:

• How do drugs go from being prescription-only to being available Over-the-Counter?
• Why are there drug ads on TV that don’t tell you what the drug is for?
• What is a generic drug? (And other questions about generic drug)
• How can I make sure I am getting a drug that is effective, safe and affordable? How can I help my doctor get unbiased information? (and other related questions)

Got a question for Ask Pharmie? Send it in.

Back in February, we ran a guest blog post here on the Prescription Access Litigation blog titled “Nat’l Women’s Health Network debunks ‘Hands Off My Estrogens!’ Ad on FDA enforcement re: “bioidential hormones”” The post addressed ads that a group called Hands Off My Estrogens ran in several major newspapers. The ads criticized the FDA for cracking down on the sales of estriol, an unapproved drug that has not been proven safe and effective. The National Women’s Health Network’s blog post analyzed the ad and its claims.

Well, we’re back for some more on the hot-button issue — last month, a group of Congressional Reps sponsored a resolution criticizing the FDA for taking action on unapproved hormones distributed by compounding pharmacies. Below is another guest blog entry by the National Women’s Health Network on this issue. We note that the National Women’s Health Network does not accept money or donations from pharmaceutical companies.

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The public’s confidence in the safety of the U.S. drug supply and in the Food and Drug Administration’s (FDA) commitment to protecting public health have been shaken by repeated drug safety scandals in recent years. So when your health care providers say one thing and the FDA says another, whom do you trust?

It’s not always an easy question to answer, but one thing is clear: drug safety decisions shouldn’t be made by politicians. We need legislators who will make sure the FDA has the authority and resources to protect our health. Unfortunately, last month members of Congress jumped into the fray in a less than helpful way, challenging an FDA decision that had stirred up controversy about the safety and effectiveness of “bioidentical” – or natural – hormones that compounding pharmacies had been selling to women as an alternative to conventional hormone replacement therapy.

Earlier this year, the Food and Drug Administration took a firm and public stand against the false and misleading promotion of natural hormones and outlined several marketing claims that it had found to be unsupported by medical evidence. The agency specifically warned that selling estriol, a chemical that has never been approved by the FDA, is a violation of federal law. (See PAL’s blog entry from dateTK, to read more about the FDA decision.)

It is this last action – the effort to stop sales of estriol – that prompted Congressional action. House Concurrent Resolution 342 calls on the FDA to reverse its policy on compounded medications containing estriol. Representative Gabrielle Giffords of Arizona, one of the original cosponsors of the resolution, says that allowing the FDA’s action on estriol to stand “would unnecessarily disrupt the lives of countless women.” She says doctors should decide which medications are safe for their patients, and the FDA shouldn’t “inject itself into the doctor-patient relationship.”

In a world turned upside down, consumer advocates who have been responsible for helping to bring to light many of the drug safety scandals that have shaken public confidence in the FDA have come to the agency’s defense. The National Women’s Health Network (NWHN), the Center for Medical Consumers, the Government Accountability Project, the National Consumers League, and the National Research Center for Women & Families wrote to Congress, to express our strong opposition to the resolution. We pointed out that estriol has not been clinically proven safe and effective and has not been approved by the FDA for any use. We also noted that compounding pharmacies selling estriol are telling women that estriol is safer and more effective than other hormone therapy products and that it will prevent serious diseases, despite a lack of scientific evidence to support these claims.

With doctors and pharmacists telling them one thing and the FDA telling them another, where can women go to get the facts? On the NWHN website, we have fact sheets for women with reliable, science-based information about conventional hormone therapy and alternatives, including natural hormones. Research on conventional hormone therapy has shown that it can increase a woman’s risk for heart disease, breast cancer and stroke. Research on natural hormones is spotty, and most of these drugs haven’t been adequately tested to support the claims being made and safety or effectiveness. When it comes to estriol, studies have found mixed results about whether it hurts or helps with breast cancer, but it’s clear that it increases the risk for endometrial cancer. Yet few of the women taking estriol have been provided with that warning.

But it’s not enough to give women information on a case by case basis. We need an FDA that we can count on to make sure that the drugs being marketed to women are safe and effective. And we need a Congress that understands and supports the important role of the FDA in regulating the drug industry. Preventing the sale of an unapproved drug is one of the most basic functions of the FDA; and yet with the estriol resolution in the House of Representatives, we have legislators claiming that it’s inappropriate for the agency to come between patients and doctors to do just that.

It’s unfortunate that the FDA’s failure to act on drug safety problems in so many cases has left women uncertain about whom to trust on questions about the safety and effectiveness of natural hormones. The case of estriol is a powerful example of why we need to build up the FDA’s capacity to evaluate and monitor drug safety, and reinvigorate the scientific leadership and integrity of the agency.

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Thanks to National Women’s Health Network for contributing this guest blog post… Readers, we welcome your comments!

The National Coalition for Appropriate Prescribing (led by the Prescription Project - a sister organization to us here at Prescription Access Litigation) is working to pass the Physician Payments Sunshine Act, a transparency bill requiring pharmaceutical companies to publicly report their gifts and payments to doctors. The Senate version of the bill is
here and the House version is here.

Pharmaceutical and medical device industry marketing to doctors (well over $30 billion each year) takes the form of gifts, honoraria and other payments. This spending subtly and not-so-subtly induces doctors to prescribe newer and more expensive treatments, regardless of whether they’re better. This in turn drives up drug costs and puts patients at risk, because new and heavily marketed drugs are almost always more expensive, even though they are often no more effective than older, established therapies. Newer drugs may also have unknown side effects.

We believe the public deserves to know how much money individual physicians are accepting from industry. (Disclosure laws in Minnesota and Vermont reveal that many doctors receive industry payments of thousands or tens of thousands of dollars a year.) The Sunshine Act will benefit patients, payers, policy makers and taxpayers alike by creating transparency.

Key provisions include:

• Comprehensive and publicly available reporting of information down to the individual prescriber level;
• A low ($25) threshold for reporting; inclusion of all payments; and
• penalties for companies that don’t report.

Sign this petition today to ask your members of Congress to support these bills: http://www.thepetitionsite.com/1/sunshine

For more information:

• To learn more about industry payments to doctors click here
• For factsheets on the Sunshine Act House and Senate bills click here
• To see the organizations that are members of the National Coalition for Appropriate Prescribing click here

Sign the petition

Sometimes the whole is not greater than the sum of the parts, just more expensive.

Last week, we reported on GlaxoSmithKline’s newly-approved combination drug for migraines, Treximet. (‘GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors“) Treximet simply combines Imitrex, a migraine medication that is going generic later this year, with naproxen sodium, better known as over-the-counter Aleve.

“Combination pills” have long been a tactic for brand-name drug companies to try to squeeze a little more profit out of drugs that are going generic — in fact, Schering-Plough and Merck are famous for another little joint venture combo drug, Vytorin (Zocor/simvastatin and Zetia/ezetimibe), which has been much in the news lately for its lackluster effectiveness.

Lately it seems like big pharma is just insulting our intelligence, repackaging drugs that have been around for a while into combo pills and trying to pass them off as “innovations” onto an unsuspecting public. That certainly seems to be the case with Schering-Plough’s (NYSE:SGP) and Merck’s (NYSE:MRK) latest proposed joint venture – a combination pill of Singulair and Claritin, two drugs approved for treatment of “allergic rhinitis,” aka allergies (Singulair is also approved to treat asthma). The two companies gleefully report that the FDA has accepted a New Drug Application for the combination.

Claritin has been available over-the-counter for several years, at an average monthly cost of $6-18, according to Consumer Reports Best Buy Drugs. Singulair is prescription-only, with its patent set to expire in 2012. Last year, Merck added new information to Singulair’s label to report new “adverse events” that were noted in people taking Singulair, including depression and suicidality (suicidal thinking and behavior).

Tellingly, the press release doesn’t claim that the combination works better than simply taking Singulair and Claritin together but in separate pills. It says “In clinical trials supporting the NDA, the combination product provided a consistent and clinically relevant effect on congestion that was not demonstrated with the individual components.” Which, as we pointed out in our entry on Treximet, is like saying that a chocolate cake tastes better than the ingredients (flour, eggs, sugar) eaten separately.

Combination drugs like these are intended to serve one purpose: to increase the manufacturers’ market share, particularly in the face of impending generic competition. Schering-Plough has been down a road like this already with Claritin — when Claritin was set to go generic, they introduced Clarinex. Clarinex (desloratidine) is simply a metabolite of Claritin (loratidine) — in a nutshell, Clarinex is what Claritin becomes in your liver. As one blogger put it, “if you’ve taken Claritin, you’ve taken Clarinex.” Thankfully, doctors and patients weren’t really fooled, and sales of Clarinex were never very impressive. I stand corrected! According to this item on Pharmalot, 2007 sales of Clarinex were $799 million! (See “Clarinex Patent Fight Nothing To Sneeze At“)

Today I’m seeking to introduce a term for combination drugs that the world doesn’t need into the pharamceutical vernacular.

“Goober Grape” Drugs

What’s a Goober Grape Drug?

Goober Grape, for the (fortunately) uninitiated, is a appalling combination of peanut butter and jelly in a single jar.

Until Goober Grape came along, millions of parents were forced to endure the mind-numbing routine of spreading peanut butter first, and then jelly. Until this breakthrough miraculously cut that spreading time in half, freeing generations of parents for loftier pursuits.

So henceforth, a “Goober Grape Drug” refers to any combination drug that offers no additional clinical advantage and only the most ridiculously minimal increase in patient convenience. There are certainly conditions in which combination pills are important, in that reducing the number of pills to be taken increases patient compliance, but allergies sure as heck ain’t one of ‘em.

If and when this Claritin/Singulair combination is approved by the FDA, we at Prescription Access Litigation will most likely give it one of our coveted Bitter Pill Awards. Till then, we’ll content ourselves with giving it our first ever designation as a Goober Grape Drug.

Will the FDA approve? Who knows! Probably, since to be approved by the FDA, a drug only has to show that it is better than a placebo (aka a sugar pill aka nothing at all). And since Singulair and Claritin have already each separately cleared that hurdle, a combination of them likely will as well. Hopefully, if it is approved, doctors, patients and insurers will give it the cold shoulder. But, to paraphrase an old saying, “No one ever went broke trying to overestimate the willingness of the American health care system to pay for drugs of questionable value.”

Update: Apparently, the FDA issued a “non-approvable” letter for this combination yesterday. (See Schering-Plough’s press release on the letter). A “non-approvable,” despite what it sounds like, does not mean that the FDA has conclusively rejected a new drug. Rather, it means the application is not approvable in its current form. Drug companies frequently amend or add to their applications upon receiving such a letter, and at times later get approval.

Readers, we invite your nominations/suggestions of other Goober Grape Drugs — please post in the comments.

Over at A Healthy Blog, our friends at Health Care For All (a member of the Prescription Access Litigation coalition) report today on the fight that is brewing in the Massachusetts legislature over a proposed ban on pharma gifts to physicians. They quote an article from yesterday’s State House News Service:

Pharmaceutical companies are attacking Senate President Therese Murray’s effort to block their firms from providing gifts, meals or trips to doctors, calling it an anti-business policy that would hobble efforts to deliver cutting-edge drugs to patients. In a letter to the chairs of the Legislature’s Economic Development and Emerging Technologies Committee, executives from Pfizer, Amgen, Abbot Bioresearch Center, Genentech, all of which have facilities in Massachusetts, ripped the gift ban as counter to Beacon Hill’s painstaking efforts to lure the life sciences industry, highlighted by Gov. Deval Patrick’s nearly year-old $1 billion incentives plan headed for legislative approval.

It’s somewhat odd to cast a gifts and lunches to doctors as being on par with a $1 billion state incentive plan — unless perhaps the gifts and trips and meals are worth more than $1 billion to the industry — after all, Massachusetts has dozens of teaching hospitals and a new health care law that means more and more people with health insurance. The prescriptions written as a result of a modest investment in gifts and trips and meals could easily garner more than a billion in new sales.

To learn more about the proposed gift ban, go visit the Massachusetts Prescription Reform Coalition.

The brand-name pharmaceutical industry constantly pushes the myth that its expensive blockbusters are breakthrough treatments that greatly increase people’s health and well-being, and thus are worth the high price-tag. That myth has more holes than a slice of swiss cheese, yet they keep pushing it on the American public like it’s one of their drugs.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of “The Truth About the Drug Companies” (see an interview with Dr. Angell in PAL’s newsletter here) famously said, “Important new drugs do not need much promotion. Me-too drugs do.” So drugs which offer little breakthrough in treatment need to be (over)hyped.

For years, the drug industry has touted antidepressants (particularly SSRIs - Selective Serontin Reuptake Inhibitors — Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Lexapro, etc. as one of its major successes. Yet, this week, a major meta-analysis (a study that reviews the full range of studies and articles on a particular drug) was published in the open-access medical journal PLoS (Public Library of Science) Medicine. That article concluded that, for the majority of patients, SSRI antidepressants are barely better than a placebo.

It’s likely that patients in the U.S. (and their health plans, and government health care programs like Medicare, Medicaid, the Veterans Administration, the military health care plan Tri-Care, etc) have spent tens of billions of dollars on antidepressants in the past decade, despite the fact that for many of them, it was likely a waste of money, exposed them to the risk of side effects, and may have resulted in their not availing themselves of other non-pharmaceutical options for treating their depression.

The billions that the industry spent on marketing these drugs, both to consumers and to doctors, led millions to believe that relief was just a pill away (We gave the makers of Paxil, one of these antidepressants, one of our Bitter Pill Awards in 2005, the Cure for the Human Condition Award: For Hawking Pills to Treat the Trials of Everyday Life).

Drugs for depression are just one of numerous groups of drugs for which the benefits are overhyped and people for whom an expensive drug is unnecessary or overkill are convinced to take it in lieu of something cheaper, that’s been around longer and whose risks and benefits are more well known.

“Statin” drugs for reducing high cholesterol are another group of drugs that have been massively overhyped, and that also have been in the news a great deal lately. Last month, the results of a study of Schering-Plough and Merck’s combination-cholesterol drug Vytorin, the ENHANCE study, were released, showing that it offered no benefit over simvastatin (Zocor), a statin that last year went generic. Vytorin is a combination of Zocor and Zetia, which is also sold by itself. Vytorin and Zetia together have more than $5 billion in sales.

Statin drugs have also been in the news because of the revelation that Dr. Robert Jarvik, Pfizer’s boat-rowing pitchman for Lipitor, is not a licensed physician, cannot write a prescription for Lipitor or any drug for that matter, and is not even a rower (a stunt double was used in the Lipitor ads). We’ve blogged about Jarvik-gate here on several occasions, including proposing some other famous “doctors” who aren’t licensed physicians that Pharma ought consider using as paid flaks — including Dr. Teeth from the Muppets, Basketball legend Dr. J, Dr. Nick Riviera from the Simpsons, and New Orleans musical legend Dr. John).

Of course, the real Lipitor story is not Dr. Robert Jarvik and his rowing and prescribing credentials. At best, he’s a bit player in this drama. The real story is how incredibly overhyped Lipitor is. Pfizer boasts it’s the “most powerful” statin as though that means that everyone with high cholesterol should be on it. But for many (perhaps most) people with high cholesterol, using Lipitor is like using a chainsaw to cut paper instead of scissors: that is, unnecessary overkill. Members of the PAL coalition filed a lawsuit against Pfizer in 2005, alleging that Lipitor had been overhyped and promoted to patients for whom it offered no benefit, and we gave them and AstraZeneca, the makers of Crestor, a Bitter Pill Award in 2006: The “Got Cholesterol?” Award: For Overpromoting Expensive Brand-Name Statins.

But even that’s not the real story — there are larger questions about statins. For instance, does lowering your cholesterol translate into a lower risk of heart attack or heart deaths on January 17 was Do Cholesterol Drugs Do Any Good? Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated.

Here are a few choice excerpts:

[Statins] are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer for its leading statin…
The second crucial point is hiding in plain sight in Pfizer’s own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”

Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.

Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.

A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out…

NNTs are the “dirty little secret” of the world of prescription drugs. And a perfect illustration of how hyping drugs through advertising to consumers and marketing to doctors (through the 100,000 salespeople employed by drug companies, self-serving biased clinical trials and corporate-influenced “continuing medical education”) doesn’t benefit patients. As the article says,

The truth about drugs’ effectiveness wouldn’t be as worrisome if consumers and doctors had an accurate picture of the state of knowledge and could make rational decisions about treatments. Studies by Darlington Hospital’s Trewby, UBC’s Wright, and others, however, show that patients expect far more than what the drugs actually deliver…

The whole statin story is a classic case of good drugs pushed too far, argues Dr. Howard Brody, professor of family medicine at the University of Texas Medical Branch at Galveston. The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders. The problem they face, though, is that many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that’s not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller.

Finally, an excellent piece posted today on Alternet examines the statin and cholesterol controversy in detail: The Cholesterol Con — Where Were the Doctors?