Community Catlayst (PAL’s parent organization) and the Alosa Foundation are offering grants as a part of a new campaign called Generics are Powerful Medicine.
The goal of Generics are Powerful Medicine is to dispel the unfounded myths surrounding generic drugs that cause patients to purchase more expensive brand name drugs rather than equally-effective and less costly alternatives. The campaign will create high-quality consumer education materials and will give grants to nonprofit organizations to undertake consumer education campaigns using those materials.
We need your help to spread the word about this exciting new program and the availability of these grants. Please inform your coworkers, colleagues, email lists and networks. Please post it on your website or blog. Please include it in upcoming newsletters or alerts to advocates and organizations. Help us get the word out! The Request for Proposals and other information can be found on the Generics are Powerful Medicine website, www.genericsarepowerful.org.
Applications for grants must be postmarked by January 15, 2008.
We consider a central part of PAL’s mission to be translating the worlds of pharmaceuticals and the law for average consumers. Why does this matter? Because both of these areas, medicines and the law, have a real impact on most people’s daily lives. Yet the details of both of them are far beyond what most people are able to understand. Take your average magazine drug ad — it has happy images of satisfied patients frolicking through fields of flowers, and then on the back it has the “brief summary.” That’s the 6-point type about the drug and all its indications, side effects, pharmacology, etc. These brief summaries are usually written in highly technical language that even most doctors would be hard pressed to understand. And consumers? Forget it.
When pharmaceuticals collide with the legal world, the confusion only gets worse. The law is littered with confusing, arcane, vague and downright impenetrable terms – many of them in Latin. How’s a consumer to understand, let alone navigate, that world?
So one of our goals is to help consumers understand and navigate those two areas, and thus to cut through what we see as the often-intentionally confusing terminology that is designed to prevent people from really understanding and acting as their own advocates. Of course, to do that, we need to be as clear as possible. We aim for this blog to be understandable to all consumers, not just pharmaceutical and health care wonks.
Are we succeeding? Well, the answer is unclear.
Literacy experts talk about “readability.” Readability is whether or not something can be read and understood by the majority of readers. You often hear it said that mainstream newspapers aim to write their articles at an 8th grade reading level. There are a variety of “tools” to measure whether something is readable. They look at sentence length, how many syllables there are in each word, how many sentences are in the passive voice, etc. They’re generally automated, and thus sometimes a bit arbitrary. For instance, the word “understandable” would score as less readable than the word “clear,” even though most 8th graders would easily understand both. So they’re a rough measure.
So how’s the PAL blog doing?
A website that supposedly grades the readability of blogs and websites is making the rounds in the blogosphere. It’s at www.criticsrant.com/bb/reading_level.aspx. No information is available about who wrote it, how they determine the readability, which of the various tools out there they use, etc. So its results must be taken with a grain of salt. Now, with all those disclaimers, here’s how the PAL blog rates:
This was very surprising to us when we first used the tool, which is here. This tool’s scale seems to from Elementary School to High School to College (Undergrad) to College (Postgrad) to Genius. We then decided to use another online tool, located here. That website provides actual results, rather than a one-word summary with no details on how it’s calculated. Here are some of our results:
Gunning Fog Index: 11.95
Flesch-Kincaid Grade: 8.10
Both the Gunning Fog Index and the Flesch-Kincaid Grade level aim to estimate how many years of education your reader has to have to understand your text. As you can see, the two produce very different results. Gunning Fog says that high school seniors (12th grade) can understand our blog. Flesch-Kincaid says 8th graders can. That’s a pretty huge spectrum, although I’m glad they conclude we’re still in the high school range. Although I’d like for the PAL blog to get as close to 8th grade level as possible, it’s probably never going to happen. We have no choice but to use pharmaceutical and legal words that tip the scale (including “pharmaceutical” itself!), even if most people understand them.
So I think it’s unlikely that our blog is really at “Genius” reading level, as the first tool claims. How could one tool put us at 8th grade level and another at “Genius?” It did lead me to wonder how other popular pharmaceutical blogs ranked. Here’s how the ones that I regularly read did:
As you can see, there are some HUGE discrepancies between the Criticsrant.com tool and the Fleisch-Kincaid and Gunning-Fog. The criticsrant.com tool, for instance, puts Cary Byrd’s edrugsearch blog at “Genius” level but Fleisch-Kincaid ranks it at just about 6th Grade. Those must be some smart 6th graders!
So I’d advise bloggers to be wary of the criticsrant.com tool, at least until some more info is released about how they actually determine readability. But there’s still an invaluable lesson to be learned: Those of us who want to educate the public about prescription drugs, medicine, the law, consumer protection and any other important topic need to always strive to make what we write “readable” to as many people as possible. This means writing clearly, avoiding complicated words when simpler ones will do, not using the passive voice, and keeping sentences short. Think like Ernest Hemingway.
Last week, GlaxoSmithKline (NYSE:GSK) filed an antitrust lawsuit against Abbott Laboratories (NYSE:ABT) for Abbott’s 400% price increase for its AIDS drug, Norvir. Strangely, the complaint was filed over three years after PAL coalition member Service Employee International Union (SEIU) Health and Welfare Fund sued Abbott for substantially the same reasons. Glaxo’s reasons for waiting three years before throwing their hat into the ring is unclear, but it may have something to do with SEIU’s success so far in its case. A group of chain pharmacies filed a similar lawsuit last month (See our post, “Chain pharmacies sue Abbott over Norvir AIDS drug price increase”). As we said about that case:
What took these supermarkets so long? It’s almost 3 years later. The filing of the suit now may have been motivated by the fact that various states have 3 year statutes of limitations (the amount of time you can file a lawsuit after an alleged “wrong” has occurred) for various kinds of claims concerning alleged fraud. Three years would be up in this instance in about a month. These supermarkets may also have seen the progress of the SEIU suit and concluded that they have a viable case as well.
SEIU and several consumers filed a national class action lawsuit against Abbott for increasing the cost of Norvir by an unconscionable 400%. Norvir is a “protease inhibitor” (PI) and was initially used by itself. Later, it fell out of favor as a standalone PI, because of serious side effects. But it became very important because (at a lower dose) it “boosts” the effects of other PIs taken by HIV/AIDS patients when they are taken together. Abbott, in fact, combined Norvir with its own PI in a single “combination” pill, called Kaletra. So patients either take Norvir with other companies’ PIs, or they take Kaletra.
Because of its effectiveness as a booster, other drug companies began designing PIs to be administered specifically along with Norvir. Abbott, by increasing the cost of Norvir by 400%, effectively increased the price of all of competing PIs since each relied on Norvir to be effective. Then, to gain a stranglehold on the market, Abbott left unchanged the price of Kaletra.
Thus, Abbott forced HIV/AIDS patients to choose between paying much more for Norvir and another PI, and switching to Kaletra, a drug that may not be medically appropriate for them. Different PIs are important at different stages of the disease, so switching between them is not just a matter of switching from one equivalent drug to another.
The SEIU lawsuit has successfully overcome motions to dismiss and motions for summary judgment . Earlier this year, the judge granted class certification. A trial is scheduled to take place in June 2008.
While the SEIU case seeks to help patients and health plans who were forced to switch PIs or pay exorbitant prices for competing drugs, Glaxo’s case seeks to recover damages for lost market share and lost profits. Abbott hiked the price of Norvir soon after Glaxo released its PI, Lexiva.
Here at PAL, we’re more concerned with the effect that this price hike had on patients and health plans than its effect on a huge pharmaceutical giant like GlaxoSmithKline. However, the price hike might have affected other drug companies’ interest in developing new protease inhibitors, and thus may also have harmed patients indirectly, as well as directly. A drug company that knows that any new PI it might develop is at a serious price disadvantage compared to Kaletra (because of the artificially high price of Norvir) might decide to put its drug development priorities elsewhere.
The recently filed Glaxo and pharmacy suits mean that there’s now a strange set of bedfellows indeed aligned against the Norvir price hike: consumers, health plans, chain pharmacies and a major brand-name drug company. This “coalition of the overcharged” underscores just how reprehensible Abbott’s price hike was. Glaxo’s suit does thicken the plot considerably. We will keep you posted on further developments.
Consumer Reports, long a critic of drug advertising, recently introduced a new feature on its website: AdWatch. In the first episode, an Associate Editor picks apart the claims made in an ad for GlaxoSmithKline’s (NYSE:GSK) drug, Requip. The ad pitches Requip as a treatment for “Restless Legs Syndrome,” or RLS. RLS, while a real condition, has been massively overhyped by ads for drugs such as Requip. (For an excellent discussion of this, see “Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick” in the free journal Public Library of Science – Medicine) Requip is a drug that was originally used for Parkinson’s Disease.
Here’s Consumer Report’s very clever and thorough deconstruction of the ad:
John Mack reports on the Pharmaceutical Marketing Blog that this critique angered folks at the Restless Legs Syndrome Foundation. Guess who’s a major sponsor of this alleged consumer group? Why, GlaxoSmithKline, of course, the maker of Requip! Here’s what John Mack wrote about this today:
However, CR does have a HUGE readership that I can only dream of! As a result, its attack on Requip drew the attention of the Restless Leg Syndrome Foundation, the supposedly grassroots patient advocacy group with suspicious monetary and corporate ties to GlaxoSmithKline (GSK), the marketer of Requip (see posts cited above).
The RLS Foundation issued this clarion call to its “members”:
“We wanted to apprise everyone on our mailing list of some bad press for RLS. We want to encourage you to ‘fight back’.
“A video on consumerreports.org promises ‘relief from restless legs hype.’ The RLS Foundation is taking a tough stand against this type of bad press for RLS.
“Click here to watch this extremely sarcastic and insulting video for yourself. Then, click here to read the RLS Foundation’s response to this video.
“The RLS Foundation is calling for drastic measures to respond to this video. We aren’t concerned that they are reporting on a drug. We are concerned that they are mocking a condition that so many people live with everyday. We encourage you to respond to this advertisement immediately. If you are a subscriber of Consumer Reports, we encourage you to cancel your subscription….”
We applaud Consumer Reports for its new AdWatch feature and for examining the Requip ad. While RLS is a real condition and some people will get relief from drugs such as Requip, the shameless overmarketing of it through ads like this is enormously harmful. The purpose of drug ads is to expand the market for the advertised drug, to convince as many people as possible that they need a particular drug, even if they don’t actually need it. Since 2005, we have been calling attention to and critiquing particularly troublesome drug ads through our Bitter Pill Awards: Exposing Drug Company Manipulation of Consumers. We’re glad to be in the company of Consumer Reports in our efforts.
We’ve been harping on Nexium for several years now. AstraZeneca’s (NYSE:AZN) supposed “healing purple pill” is nothing more than a dressed-up version of its previous blockbuster gastric reflux drug, Prilosec. We gave Nexium a Bitter Pill Award in 2005, the The Least Extreme Makeover Award: For Dressing Up an Old Drug with a New Name and a New Price Tag. Our members have been involved in several class action lawsuits alleging the Astra Zeneca deceptively marketed Nexium as an improvement over Prilosec, when in fact it is clinically no different. (As we’re fond of saying, the only difference between Nexium and Prilosec is that Nexium has yellow stripes and costs seven times as much).
We’ve always marveled at why Nexium is as successful as it is when Prilosec is available Over-the-Counter at a fraction of the price. The answer, of course is simple: Marketing. As we’ve written (see, for example “Top 3 Bestselling Drugs spent $460.5 Million on Ads in 2006″), Nexium owes its $4.3 billion in 2006 annual sales to the $176 million that Astra Zeneca spent that year on ads like this:
Now there’s even less of a reason for people to use Nexium instead of cheaper alternatives, including Over-the-Counter Prilosec. FDANews.com reports that Dexcel Pharma Technologies will soon begin selling a generic version of Over-the-Counter (OTC) Prilosec. Astra Zeneca sued Dexcel to prevent it from selling generic OTC Prilosec, but has settled that lawsuit with Dexcel.
Most people think of generics when they think about prescription drugs, not Over-the-Counter ones. But drug companies frequently get FDA permission to stop generic competitors for 3 years when a drug first becomes available over-the-counter. This is why up til now, you haven’t seen, for instance CVS or Walgreen store brand Prilosec.
Dexcel says that OTC Prilosec should be available by the end of March 2008. The competition between Astra Zeneca’s Prilosec and Dexcel’s generic version should drive the price down. This is yet another reason consumers don’t need to pay through the nose for prescription-only Nexium.
But even before you reach for that cheaper box of OTC Prilosec, you should consider whether even less expensive alternatives will do the trick — such as Tums, Zantac, Pepcid, and other over-the-counter heartburn drugs. Consumer Reports Best Buy Drugs has a report on heartburn medicines, and it says, in part:
If you suffer from only occasional heartburn and have not been diagnosed with GERD [gastric reflux disease], nonprescription antacids such as Maalox, Mylanta, Rolaids, and Tums, or acid–reducing drugs such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) will very likely provide relief.
Talk with your doctor about the role that dietary and lifestyle changes can play in alleviating heartburn, too – such as eating smaller meals, weight loss, and avoiding alcohol.
Judge Patti Saris of the US District Court for the District of Massachusetts today issued an order in the massive national class action lawsuit, In re Pharmaceutical Industry Average Wholesale Price Litigation. In it, she found Astra Zeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) liable for double damages for their illegal conduct in artificially inflating teh Average Wholesale Prices of a number of physician-administered drugs. She had previously held in June 2007 that these companies had violated Massachusetts law in doing so, but had not ruled on the amount of damages they would have to pay. Today’s order is here.
Below is the press release that PAL issued today on this important development:
_____________________________________
FOR IMMEDIATE RELEASE
November 2, 2007
Consumer Groups Applaud Federal Court Decision in Drug Price Fraud Case Judge Awards “Double Damages” against Astra Zeneca and Bristol Myers Squibb
BOSTON, MA – Judge Patti B. Saris of the U.S. District Court for the District of Massachusetts issued an order today in the massive class action lawsuit, In re Pharmaceutical Industry Average Wholesale Price Litigation, awarding double damages against Astra Zeneca (NYSE:AZN) and Bristol Myers Squibb (NYSE:BMY) for illegally inflating the “Average Wholesale Prices” (AWPs) of certain physician-administered drugs. Astra Zeneca (AZ) will have to pay $12,941,869 in damages, and Bristol Myers Squibb (BMS) will have to pay $695,594.
A trial against these two companies and several others was held over several months in late 2006 and early 2007. In June 2007, the Court issued its order resulting from that trial, finding that AZ, BMS and Warrick Pharmaceuticals (a subsidiary of Schering Plough) had violated the Massachusetts Consumer Protection Act (Chapter 93A) by grossly inflating the AWPs for a number of drugs. In that June order, however, the Court did not award final damages against the defendants, requesting additional information from the parties. The order issued today is the Court’s ruling on those damages. One of the key issues the Order addresses is whether the damages should be multiplied or not.
Under the Mass. Consumer Protection Act, a Court can order the doubling or even trebling of damages against defendants for “unfair and deceptive” conduct, if the conduct was “knowing and willful.” Judge Saris found that AZ’s and BMS’s conduct in inflating the AWPs of the drugs in question was knowing and willful, because they knew that Medicare patients and their insurers would have no choice but to pay 20% co-insurance on the “grossly inflated phony AWPs.” She awarded double damages against Astra Zeneca because it “sold its drug Zoladex based on its profitability to the doctor’s office…[t]he damage to the sick and old beneficiaries was inevitable.” She awarded double damages against BMS for certain years for the drugs Taxol, Cytoxan and Rubex. These double damages apply to a class of Massachusetts health plans that provide Medicare supplemental insurance. For a separate class of non-Medicare Massachusetts health plans, she awarded single damages.
“This is a major victory for consumers and health plans in Massachusetts,” said John McDonough, Executive Director of Health Care For All, a plaintiff in the case and a member of the Prescription Access Litigation (PAL) coalition. “Drug companies have been put on notice that illegally inflating drug prices at the expense of seriously ill seniors and the disabled will cost them dearly in Massachusetts.”
Blue Cross Blue Shield of Massachusetts was also a plaintiff in the case, as was PAL coalition member Pipefitters Local Union 537 Trust Funds.
The Judge’s order applies only to health plans in Massachusetts, as the trial addressed claims under Massachusetts state law. Claims against these defendants in the 49 other states must still be heard by the Court. The lawyers representing the plaintiffs estimate that, if one extrapolates the numbers in Massachusetts to the other 49 states, total nationwide damages against these two companies could exceed $200 million.
Both Bristol Myers Squibb and Astra Zeneca previously had agreed to settle some of the claims against them, claims that the price increases harmed a nationwide class of millions of individual Medicare beneficiaries. Astra Zeneca agreed in May 2007 to settle those claims for $24 million and Bristol Myers Squibb agreed in July 2007 to settle for $13 million. Another defendant, GlaxoSmithKline, settled all the claims aginst it in August 2006 for $70 million, and thus was not part of the trial that began in fall 2006.
Today’s order is just the latest development in this massive nationwide class action suit against dozens of drug companies. The next round of trials, addressing hundreds of additional drugs, is currently scheduled to begin in spring 2008.
“The Judge’s decision in this case exposes one of the most reprehensible drug industry schemes in recent memory,” said Alex Sugerman-Brozan, director of Prescription Access Litigation, “Overcharging people on Medicare with cancer and other serious illnesses and their health plans is as appalling as it gets, and this decision should give the other companies in this lawsuit some indication of what may lay ahead for them.”
Today’s order brings the total amount of settlements and judgment in the case so far to over $120 million. The order can be found here.
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About Prescription Access Litigation
The Prescription Access Litigation (PAL) (www.prescriptionaccess.org) Project works to challenge illegal pharmaceutical industry tactics that increase the cost and improper usage of prescription drugs, using class action litigation and public education. PAL is a national coalition of more than 130 organizations, including consumers, seniors, heath care, labor, legal services, women’s health and human services groups in 36 states and the District of Columbia. PAL is a project of Community Catalyst, a national non-profit advocacy organization working to build the consumer and community leadership that is required to transform the American health system. PAL publishes the PAL Blog at www.prescriptionaccess.org/blog.
About Health Care For All
Health Care For All (www.hcfama.org) is building a movement of empowered people and organizations in Massachusetts with the goal of creating a health care system that is responsive to the needs of all people, particularly the most vulnerable. Health Care For All is dedicated to making quality care the right of all people, and supports a health care system that is universal, comprehensive, and equitable.
Very funny parody song/ad for a new drug called “Paracetamoxyfrusebendroneomycin.” The lyrics make various references to the UK’s National Health Service, the jokes about it which are mostly lost on us here in the U.S. However, the rest is more or less universal.
And then, another by the same group of British lads, the Amateur Transplants. This one appears to be inspired by the great Tom Lehrer’s song about the Periodic Table of Elements, sung to the tune of Gilbert & Sullvan’s “Modern Major General”
A recent and welcome addition to the pharmaceutical blogosphere is PostScript, the blog of The Prescription Project (a sister project of Community Catalyst, which is PAL’s parent organization). PostScript has been featuring a series of fascinating interviews with various medical professionals, on the topic of medical ethics and interactions with the pharmaceutical industry. The latest is “How Hooked Happened: a conversation with Howard Brody, M.D.” Dr. Brody is author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Have a look. Here’s a good quote from that interview. I’ve bolded the particularly juicy parts:
Reform has to be a two-pronged thing. First, a professional level of reform: individual physicians growing a certain underdeveloped piece of anatomy….we need our professional spines to be strengthened. And the second piece is regulatory reform: We need to take back medical research from the pharmaceutical industry. There’s got to be some accounting for the bennies [ed: benefits, that is] that these contract research organizations and investigators get from the drug companies.
The public simply cannot demand further tax cuts unless they confront the fact that they are selling medical integrity to the hands of private industry. I think that means we are going to have to pay so that science remains a public good, and not property of the commercial outfits.
Back in 2001, TAP Pharmaceuticals, a joint venture of Abbott Laboratories (NYSE:ABT) and Takeda Pharmaceuticals, pleaded guilty to illegal marketing and pricing of its prostate cancer drug Lupron, and agreed to a $875 million settlement. This was the largest health care fraud settlement to date, and the first in what has become a wave of federal prosecutions against drug companies for such fraud. (The settlement reimbursed government programs, but not consumers and private health plans. A $150 million national class action settlement, in which PAL was involved, provided reimbursement to those private parties.)
As reported today by BNA Health Care Daily, a TAP account manager who was convicted of perjury for testimony given to the grand jury in the government case, will serve 5 months in federal prison:
BOSTON–A former regional account manager for TAP Pharmaceutical Products Inc., convicted of perjury in 2004, was sentenced Oct. 30 to five months in prison (United States v. Richardson, D. Mass., No. 02-cr-10211, sentencing 10/30/07).
Joanne Richardson, whose conviction was upheld by the U.S. Court of Appeals for the First Circuit in 2005 (No. 169 HCDR 9/1/05 a0b1j9h8c2), also was fined $3,000 and ordered to spend two years on supervised release, including five months of home detention, following her prison term.
Richardson had been found guilty in the U.S. District Court for the District of Massachusetts of making false declarations to a grand jury investigating TAP’s business practices.
Earlier this year, U.S. District Court Judge William G. Young threw out a sentence of six months in prison, imposed in 2004, finding that her attorney had ineffectively represented her by failing to note on appeal a change in the status of mandatory sentencing guidelines. The new sentence was imposed by U.S. District Judge George A. O’Toole Jr.
In seeking to avoid imprisonment, Richardson argued that her conviction was for lying about the conduct of coworkers who subsequently were acquitted, and that several notable public figures, including former vice presidential chief of staff I. Lewis Libby, had avoided incarceration for similar offenses.
In October 2001, TAP pleaded guilty to illegally pricing and marketing its cancer drug, Lupron, as part of an $875 million settlement to resolve criminal and civil charges of wrongdoing. However, 11 former TAP sales executives and managers were found not guilty of defrauding the government and paying kickbacks after a three-month trial in July 2004.
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