The Council is the umbrella organization of union retirees clubs and local unions with retirees throughout Minnesota. It provides retired union members and spouses official representation within the Minnesota AFL-CIO, and enables retired trade unionists to speak with a unified voice on public policy issues. The Council publishes a bimonthly newsletter, the Gopher Retiree, and produces a local cable television show, Voices of Experience.
The Prescription Access Litigation coalition has more than 130 organizational members that represent over 13 million individuals. The coalition includes consumer advocacy organizations, senior citizen groups, health care advocacy groups, labor unions, union benefit funds, nonprofit health plans, and others. PAL coalition members join class action lawsuits, help get the word out about new lawsuits and settlements, and participate in advocacy campaigns to curtail runaway drug marketing and unethical drug pricing. If your organization is interested in joining the PAL coalition, learn more here.
Thanks to Patent Baristas for tipping us off to the latest online pharmaceutical Flash-plugin board game craze, Biologicsland! Biologicsland is brought to you by the wacky folks over at Teva Pharmaceuticals. Teva (NASDAQ:TEVA) is the largest generic drug company in the world, with 2007 sales of $9.4 billion and 28,000 employees.
As you can see, it bears a striking resemblance to the source of its inspiration, Candyland, minus the Molasses Swamp: (which would be what, in this case? Congress? the FDA? The Biotechnology Industry Organization?)
Biologic drugs are vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins that are are isolated from a variety of natural sources – human, animal, or microorganism, as opposed to conventional drugs, which are chemically synthesized.
The issue of generic biologic drugs, or “follow-on biologics” as they’re wonkily known, is a complicated one, and difficult to explain to the public. In a nutshell, supporters (including us here at PAL) of legalizing generic versions of biologic drugs (again, the wonkish translation is “creating a pathway for follow-on biologics) argue that biologic drugs are going to be a budget-buster for the health care system over the next ten years, and that the science has sufficiently advanced to enable the creation of equally safe and effective “generic” versions of biologic drugs.
Legislation has been proposed to allow for generic biologics, but so far has not passed. The prospects for passage in the coming year are better, however, with both presidential candidates publicly supporting generic biologics. Teva is obviously trying to get the issue more in the public eye with this game, and trying to make it less intimidating and confusing. Of course, you can only get across so much information and complexity in a board game…
It’s being widely reported this morning (See, for example, the WSJ article here and the AP article here) that Pfizer (NYSE:PFE) has agreed to settle the bulk of the lawsuits against it related to the increased risk of heart attacks and strokes from the painkillers Celebrex and Bextra.
The $894 Million settlement includes $745 million to settle 90% of the personal injury suits brought by patients who were allegedly physically injured by the drugs, $60 million to resolve primarily Bextra suits brought by Attorneys General in 33 states and the District of Columbia, and $89 million to settle suits brought by consumers and “third party payors” who alleged that they defrauded by Pfizer’s marketing and failure to disclose the risks of the drugs into paying for them when they otherwise would not have.
Even after the increased risks of Celebrex, Vioxx and Bextra became common knowledge, Pfizer kept Celebrex on the market, and even resumed TV ads for it, running an unusually long ad which extensively described the drug’s risks, but sought to downplay the risks by claiming that all NSAIDS (the class of drugs Celebrex is in) carry the same risks. Here is the ad:
At the time of this entry, no further details about the settlement were available, and the settlement itself had apparently not been filed in Court (Pfizer’s press release described the settlement as “Agreements in Principle”)
Prescription Access Litigation’s parent organization, Community Catalyst, launched a new program this summer in conjunction with the Alosa Foundation called Generics are Powerful Medicine. Generics are Powerful Medicine (GPM) is a national project to educate consumers about the safety, value and effectiveness of generic drugs. In 11 states, community organizations partnering with GPM are actively conducting outreach to low-income and uninsured populations to provide information and education on generic drugs.
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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:
Imitrex patients who switch to Treximet before the generic becomes available who choose to stay on Treximet
New patients who start on Treximet without ever having taken Imitrex
Imitrex patients who switch to Treximet before the generic becomes available who then switch to generic Imitrex,
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.
Recently, the FDA requested comments on direct-to-consumer (“DTC”) advertising, and its effects upon subsets of the general population, such as the elderly, children, and racial and ethnic minority communities.
PAL and our sister organization, the Prescription Project (www.prescriptionproject.org ) weighed in on the relationship between DTC advertising and the risks and costs of prescription drugs. Our assessment overall was that
“direct-to-consumer advertising produces no proven public health benefits and likely plays a role in driving unnecessary use of pharmaceuticals. Manufacturer-sponsored television advertisements, in particular, are ill-suited to effective communication of risk-benefit information about prescription drugs. Elderly consumers, the less-educated and those with English as a second language may be at particular risk for misunderstanding the potential risks and benefits associated with advertised drugs.”
First, we noted that there is evidence that DTC ads prompt people to discuss advertised conditions and treatments with their doctors – in short, DTC ads work. Why else would the drug companies spend increasing billions each year on drug ads. But, more importantly, we point out that there is no evidence that what ‘works’ to sell drugs is of any benefit for patients. To the contrary, there is abundant evidence of the harm and cost of DTC advertising to consumers.
Populations at risk.
Drug companies tend to focus their advertising on new drugs, with the hopes of finding the next billion-dollar block-buster. When successful, ads drive a rapid increase in prescribing that can expose a large number of the public to the health risks and previously-unknown side effects associated with the new drug. (Clinical trials of new drugs that drug companies run as part of getting FDA approval usually involve only a few thousand participants for a short time, usually less than two years. Therefore side effects that are rare, or that emerge only after patients have used a drug for a longer period of time, may only become obvious once the drug is on the market for a while and being taken by millions of people.)
Vioxx: The Poster Child for Drug Usage Driven by Advertisements
Developed as a daily-use pain reliever, Vioxx was no more effective than ibuprofen (Advil) or naproxen (Aleve). Its only established improvement over these older, time-tested (and much cheaper!) medicines was a decreased risk of stomach bleeding and ulcers. However, no more than 2-4% of patients are at risk for developing these stomach problems. As a result of the substantial DTC advertising and other aggressive promotion, Vioxx use soared from 1999 until its recall on September 30, 2004. Our comment notes that the rapid explosion of Vioxx use, made possible in part by DTC advertising, was
“responsible for an estimated 88,000 to 140,000 cases of serious coronary heart disease and an estimated 38,000 to 61,000 deaths in the USA.”
Even without these risks, DTC advertising drives up health care costs. DTC advertising promotes medically unnecessary prescribing that offers “little or no meaningful clinical benefit for many patients….” This is true of cholesterol lowering agents, allergy medications, antidepressants, and many other types of heavily advertised drugs.
For instance, we noted one study in which actors went to doctors offices posing as patients, and specifically asked for Paxil after supposedly seeing an ad. Doctors wrote prescriptions for Paxil in very high percentages even when the purported condition was one for which there was little evidence (minor depression), or even no evidence (social adjustment disorder) that Paxil was an effective treatment. This illustrates how DTC advertising helps fuel medically inappropriate use.
Debunking drug industry propaganda that DTC advertising promotes public health
In our comments, we took the opportunity to review the many other submissions to the FDA by drug companies which claimed that DTC advertising promotes public health. We noted that most of their purported ‘proof’ were ‘opinion surveys’ of how doctors or patients felt ads helped lead to needed diagnoses or treatment. Only one cited study looked at how often ads lead a patient to seek diagnosis. But we noted that there were no studies proving that DTC ads actually lead to objectively measured, medically necessary and appropriate care.
DTC advertising is not balanced
Under federal regulations, promotional materials for prescription drugs must achieve a ‘fair balance’ between showing the benefits of a drug, and its risks. Also, promotional materials must provide adequate warning of the possible risks or adverse side effects.
The heart of the problem with direct to consumer advertising is that it does not achieve this ‘fair balance.’ DTC ads have been shown to focus more on the benefits, and to downplay or undermine the viewer’s understanding of risks. As a result, one study found that patients can accurately describe the benefits of drugs 80% of the time, but can only understand the risks 20% of the time. This is because drug ads spend more time describing a drug’s benefits, using easier language, with frequent repetition. In contrast, drug risks are often presented more quickly, in more difficult language, with other audio and visual distractions.
We recommend that FDA closely examine whether DTC ads can or do achieve a ‘fair balance’ between benefits and risks, given the ads representation of, and the public’s perceptions of, these risks. In addition,
“it must be remembered that DTC advertising drives attention to conditions chosen for their return on investment, not their importance in improving the public health.”
PAL’s and Prescription Project’s comments are here.
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’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!
As we’ve previously reported on the PAL blog, GlaxoSmithKline agreed to pay $40 million to settle a national class action lawsuit brought against it on behalf of “third party payors” (health plans, union benefit funds and others). The case alleged that GlaxoSmithKline (NYSE:GSK) defrauded third party payors by failing to disclose the increased risk of suicidal thoughts and behavior among children and adolescents taking the prescription antidepressants Paxil® and Paxil CR®.
On September 30, the U.S. District Court for the District of Minnesota held a “Final Approval” hearing in the case. Lawyers for the plaintiffs, defendant and objectors all made presentations to the Court about why the settlement is “fair, reasonable and adequate” and why it should be approved. The Court issued its order granting final approval to the settlement shortly after the hearing ended.
Now that the settlement has received Final Approval, payments can be made to Third Party Payors that paid for Paxil for pediatric patients between 1998 and 2004. The deadline to submit claims forms is December 12, 2008. A letter will go out shortly to 42,000 third party payors that had previously received a notice by mail of the settlement. The letter will apprise them of the changes to the settlement that the objectors were able to negotiate, and let them know about changes to the claims form. As of this writing, the claims form had not yet been updated on the settlement website – www.pediatricpaxiltppsettlement.com. We urge third party payors to check back soon at pediatricpaxiltppsettlement.com to see if the new form has been posted, or to call the Settlement Administrator at 1-800-396-5655.
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.
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.