TAKE ACTION FOR LOWER DRUG COSTS! STOP PHARMA’S BACKROOM DEALS!

Working with consumer advocates across the country, Consumer Catalyst has launched a campaign to stop  ‘Pay-for-Delay’ deals that hurt consumer health!

What you can do:

1. Sign the consumer petition on Change.org
2. Join the discussion on twitter and share your story, using the hashtag: Stop the #RxRacket! And ask others to share their stories too. Also follow us at @postscriptrx.
3. Join our community on Facebook to keep up with the campaign and join our email list of impacted consumers by sharing your story.

You can also tell us your story, if you are interested in joining us as a consumer advocate and speaking out on these issues to local media.

Pharmaceutical companies are colluding to keep drug prices high – and taking that money right out of your pocket.

Did you know drug companies have made more than 160 secret, back-room deals that

• Have kept 100 generic drugs or more off the market for years
• Drive up the cost of each drug by an average of $3,000 a year
• Keep all of our prescription costs high, while divvying up the spoils!

Right now, the Supreme Court is currently deliberating over whether these back-room deals are legal – but we know they’re wrong. Since 2005, as many as 142 different generic drugs have been unfairly kept from consumers, according to government reports. Delaying the launch of a generic drug lets the drug companies make bigger and bigger profits, while patients are stuck footing the bill, or going without the medicines they need.

The Supreme Court heard arguments by the drug companies, and fortunately Justices Kagan and Sotomayor raised consumer concerns – but the Court did not hear the perspective of the thousands of Americans unable to afford their medications. That’s because most people don’t even know that these deals are costing consumers thousands, and our health system billions of extra dollars, each year!

Help us raise awareness of this #RxRacket. The public deserves to know how this decision will affect us all – how thousands of Americans are being forced to choose between skipping their medications or going into credit card debt, just so that drug companies can make even more profit. Not to mention, how health care costs for everyone have gone up, because insurers pay most of these higher costs!

Whatever the Supreme Court decides, help spread the word, so we can help make sure that these deals come to an end, once and for all.

Target drugs: 
If you have taken Cipro, Provigil, or Androgel, you have definitely paid more because of a pay-for-delay settlement. And according to legal experts, it is very probable that many drugs including blockbuster drugs like Lipitor, Plavix and Nexium — have been delayed by pay-for-delay deals.*

We need you to tell everyone you know that this is happening, and help gather and share the stories of people you know that have been negatively impacted. Read the stories shared by two women, Tanna and Karen, who were unable to afford their medications due to pay-for-delay deals that kept generic Provigil off the market for six years. Also, read how the companies’ legal arguments make no sense.

You can find all the information you would ever need about this issue on our Pay-for-Delay info page. Please also feel free to add your thoughts on this #RxRacket in the comments, below.

Thank you for helping us protect your right to affordable medicine!

*The Full List – Drugs Likely to Have High Prices from ‘Pay-for-Delay’ Deals:
Adderall XR, Aggrenox, Altace, Arthrotec, Caduet, Carbatrol, Clarinex, Comtan, Duac, Effexor XR, Eloxatin, Ethyol, Femcon Fe, Fentora, Flomax, Lipitor, Lamictal, Levaquin, Lexapro, Loestrin-24 Fe, Loprox, Lotrel, Lybrel, Namenda, Naprelan, Nexium, Niaspan, Niravam, Olux, Opana ER, Ortho Tri Cyclen Lo, Oxytrol, Plavix, Propecia, Razadyne, Razadyne ER, Rythmol SR, Sinemet CR, Skelaxin, Solodyn, Stalevo, Tricor 145mg, Vanos, Vfend, Wellbutrin XL (150 mg), Xopenex, and Zantac!

Members of Prescirption Access Litigation’s coalition are plaintiffs in a national class action lawsuit that alleges the Cephalon (Nasdaq:CEPH) illegally took steps to keep a less expensive generic version of its narcolepsy drug Provigil off the market, including paying off generic drug companies that challenged Cephalon’s patents on Provigil to not try to bring a generic to market. So we follow news about Provigil quite closely.

Back in September, we wondered aloud “Why did Cephalon close its Provigil Patient Assistance Program.” We speculated:

Cephalon jacked up the price of Provigil 14% back in March [2008], according to a Bloomberg News report. US sales of Provigil for the first half of the year were $417 million. Given that Provigil’s total 2007 sales were $744 million, the drug’s sales are growing….

Provigil is clearly a money maker for Cephalon, approaching the magic $1 billion “blockbuster” market. Provigil has on the one hand deprived consumers of a more affordable generic and on the other hand told uninsured patients seeking assistance that they’re out of luck halfway through the year….

One can’t help but wonder if the Patient Assistance Program’s closure has anything to do with the anticipated introduction next year of Nuvigil, a “successor drug” to Provigil. Nuvigil (armodafinil) is the “single isomer” formulation of Provigil (modafinil), which means that Nuvigil is just one half of the molecule that gives Provigil its kick.

The Wall Street Journal reported this week in How a Drug Maker Tries to Outwit Generics:

Twice this year, Cephalon Inc. has sharply raised the price of its narcolepsy drug Provigil. The drug is now 28% more expensive than it was in March and 74% more expensive than four years ago…The Frazer, Pa., company has said in investor presentations that it plans to continue to raise the price.

The Provigil price increases — the drug’s average wholesale price is now $8.71 a tablet — are an extreme example of a common tactic pharmaceutical companies employ in the U.S. to boost profits and steer patients away from cheaper generics.

It works like this: Knowing that Provigil will face generic competition in 2012 as its patent nears expiration, Cephalon is planning to launch a longer-acting version of the drug called Nuvigil next year. To convert patients from Provigil to Nuvigil, Cephalon has suggested in investor presentations it will price Nuvigil lower than the sharply increased price of Provigil.

By the time copycat versions of Provigil hit the market the company is banking that most Provigil users will have switched to the less-expensive Nuvigil, which is patent-protected until 2023. In the meantime, Cephalon will have maximized its Provigil revenue with the repeated price hikes.

“You should expect that we will likely raise Provigil prices to try to create an incentive for the reimbursers to preferentially move to Nuvigil,” Chip Merritt, Cephalon’s vice president of investor relations, told a Sept. 5 health-care conference, according to a transcript of the meeting.

A more cynical statement by a pharmaceutical spokesperson is hard to find, and that’s saying a lot. What this statement means is that Cephalon is apparently willing to force patients to pay more — for no reason other than to boost sales of its new drug, Nuvigil, and get patients and physicians to switch to it – all before a generic version of Provigil hits the market, which likely will cost 70-80% less than Provigil within a year of a generic being available.

Increasing drug prices, of course, are apparently par for the course in the U.S. But, as the WSJ points out, “Provigil’s price increase over the past four years has been almost four times steeper than the 4% compound annual growth rate of the average drug price during that period, according to a DestinationRx analysis of 2,570 brand-name drugs.”

We at PAL hear from patients on a daily basis who cannot afford Provigil. These include people who are uninsured, people who are in the Medicare Part D “donut hole,” people who have qualified for Social Security Disability Income (SSDI) but who are stuck in the ridiculous 2 year waiting period to get on Medicare, and people whose insurance won’t pay for Provigil.

For many of these people, they need Provigil in order to have functioning daily lives — we’re not talking about, as the WSJ describes, people take Provigil for uses not approved by the FDA, “as a ‘lifestyle drug’ to help them stay awake during work or leisure activities.” We’re talking about people like Jessica, who described her inability to afford Provigil in Jessica’s story: No help from Cephalon for cost of Provigil.

Making payoffs to keep generic Provigil off the market, raising its price at a rate four times higher than other drugs, closing its patient assistance program halfway through the year — all we can say is shame on Cephalon.

(Got a Provigil story to tell? Post a comment below.)

We’ve written about in the past on the PAL blog about, Provigil, a prescription drug used to treat narcolepsy and other sleep conditions, which is made by Cephalon (NasdaqGS:CEPH). [See previous posts such as "FTC member speaks out on Provigil generics payoff case," and "Jessica’s story: No help from Cephalon for cost of Provigil"]

Cephalon is alleged to have paid off four generic drug companies to keep more affordable generic versions of Provigil off the market. PAL member AFSCME District Council 37 Health & Security Plan joined a nationwide class action lawsuit in Eastern Pennsylvania against Cephalon and the four generic companies (Teva, Ranbaxy, Barr and Mylan) on behalf of a nationwide class of consumers, health plans and other “third party payors.”

The Federal Trade Commission also sued Cephalon back in February, in the U.S. District Court for the District of Columbia. Yesterday, the Judge hearing that case ordered that the FTC’s case be transferred to the Eastern District of Pennsylvania, where the class action lawsuit is pending.

In ordering the transfer, the Judge in the FTC case primarily relied on the conclusion that having the FTC case and the class action before the same Judge would avoid “inconsistent judgments.” As Judge John D. Bates wrote in his opinion:

The most compelling point in Cephalon’s favor is the risk of inconsistent judgments that would arise if this case is not transferred. Although there are some differences between the private parties’ claims against Cephalon and the government’s case — namely that the private litigants must demonstrate antitrust injury and prove damages — at the core the two matters involve identical issues of fact and law. Hence, absent transfer to the Eastern District of Pennsylvania, Cephalon would be forced simultaneously to litigate two cases in two different courts arising out of precisely the same conduct. That obviously presents a serious risk of inconsistent judgments. If this Court, for instance, were to find that reverse-payment settlements are lawful while the district court in Pennsylvania reached the opposite result, or vice versa, Cephalon would face a classic case of conflicting judgments. That is exactly the sort of inconsistent result that transfer can ameliorate.

The Judge then went on to accuse the FTC of “forum shopping,” and of in fact looking to create inconsistent judgments so as to increase the likelihood that the Supreme Court would accept a case and determine once and for all whether reverse payment settlements violate the antitrust laws. As the Judge wrote:

Indeed, the FTC would likely be content if this case did result in inconsistent judgments. That is because, as Cephalon points out, the Commission is rather openly shopping for a circuit split on the issue of reverse-payment Hatch-Waxman settlements, and all the better if the FTC could potentially arrange for two courts of appeals — the Third and D.C. Circuits — to decide that question in the context of what is essentially the same case. To be sure, the Commission is free to exercise its prosecutorial judgment to pursue a strategy that it believes will ultimately result in Supreme Court review. But it strikes this Court as both odd and unreasonable to do so at the expense of exposing a single defendant (engaged in a single course of conduct) to conflicting judgments in order to advance the agency’s enforcement goals. The danger, and burden, of inconsistent judgments against one defendant based on the same events, in short, outweighs whatever legitimate interest the FTC may have in achieving that result for strategic reasons.

In 2006, the Supreme Court refused to hear an appeal in a case the FTC brought against Schering-Plough, challenging a payoff of a generic drug maker that had sought to bring a generic version of Schering’s K-Dur to market. Similarly, the Supreme Court had also refused to hear an appeal of a class action originally brought in federal court in New York, challenging a generics payoff concerning the prescription drug for breast cancer, Tamoxifen.

These two refusals by the Supreme Court to address the issue of whether a brand-name drug company paying off a generic drug company not to bring a generic to market violates the federal antitrust laws left the question open. Since that time, there has been a resurgence of such payoffs, resulting in consumers being deprived of less expensive generic drugs.

We at Prescription Access Litigation remain committed to challenging such deals and exposing them for the crude, anti-consumer payoffs that they are. It’s unclear what effect the transfer of the FTC’s case to Pennsylvania will have. Stay tuned.

We recently posted an item discussing a New York Times article about Genentech’s drug Cerezyme . One reader posted a comment on that item, and her story is so compelling that we asked her if we could post it as a stand-alone blog entry. She agreed. Jessica’s story appears below, in which she describes the difficulties she’s faced in affording her prescription for Provigil, which she needs to treat her narcolepsy.

One of the reasons that Provigil is so expensive (about $200 for 30 tablets of 100 mg, and about $270 for 30 tablets of 200 mg) is that there is no generic version available. Why is there no generic version available? Largely because Cephalon (NASDAQ: CEPH), the manufacturer of Provigil, filed patent infringement lawsuits against generic drug companies that tried to bring a less expensive generic version to market. Then Cephalon paid them off, to the tune of more than $130 million, not to sell generic versions of Provigil until 2011 at the earliest. PAL member AFSCME District Council 37 Health & Security Plan is a plaintiff in a national class action lawsuit challenging these payoffs.

Earlier this week, it was reported that Cephalon’s CEO, Frank Baldino, got $13.5 million in compensation last year. This is much more than CEOs at other, much larger, drug companies earned last year, including Pfizer and Bristol Myers Squibb. This news will certainly be of no comfort to patients like Jessica.

Without further ado, here’s Jessica’s story. At her request, we’re using only her first name. The opinions expressed and events described below are hers and not necessarily ours.

Cephalon makes a similar claim as Genentech’s to provide “the drug free, if necessary, so that no one goes without the product because of its cost.” Cephalon’s PROVIGIL Assistance Program is solely administered by the National Organization for Rare Disorders (NORD). The NORD website asserts that their Patient Assistance Programs

“assist uninsured or under-insured individuals in securing life-saving or life-sustaining medications. In addition to the estimated 50 million Americans who have no health insurance, an increasing number of insured individuals have policies that do not reimburse for prescription drugs. Others have policies with low annual caps on prescription drug expenditures. NORD works closely with humanitarian-minded pharmaceutical and biotechnology companies to ensure that certain vital medications are available to those individuals whose income is too high to qualify for Medicaid but too low to pay for their prescribed medications.”

But it turned out Cephalon was not as “humanitarian-minded” as NORD would have you believ

When my health insurance dropped Provigil from their formulary in 2007, my Provigil copay jumped from $50/month to $234/month in addition to a $500 brand name deductible and my $130 monthly premium. I’m not sure why my insurer took Provigil off the formulary (I asked them and they didn’t know either) but I wouldn’t be surprised if it was in response to Cephalon’s prohibiting the generic versions that were supposed to come out in 2006. I realize $234 a month is nothing compared to many HIV and cancer drugs. But $234 is a lot when you consider that my Narcolepsy prevents me from being able to work more than 15 hours/week (with medication) and that I am only 26 and will be dependent on drugs like Provigil for the rest of my life. I was barely scraping by with a $50/month copay so I suddenly found myself unable to front the costs to buy even a one-month supply of Provigil. I had to stop taking my medicine which meant I could no longer work at all.

Desperate to find a way to get my medicine so I wouldn’t end up on welfare, I called Cephalon’s PROVIGIL Assistance Program and requested financial assistance. I was still willing to pay part of the costs, but I hoped they could give me some sort of rebate. Cephalon told me that because I had some form of insurance I didn’t qualify for any assistance, regardless of how high my co-payment is or my financial situation. They told me that if I was uninsured they would pay up to $500 per month (which is the retail cost of a month supply for me). They actually suggested I drop my insurance plan. It seems strange (not to mention unethical) that they would rather I drop my insurance so they could give me $500/month instead of just helping me with a portion of my $235 co-pay. It is cheaper for them if I have insurance. And if they can afford to shell out $500 a month to every uninsured patient, why can’t they just reduce the price for everyone so less people will need their financial assistance in the first place? They would probably make more money if they charged less because patients like me wouldn’t be forced to stop taking the medicine all together.

I actually considered listening to them and dropping my insurance so I could get free medication, but that ultimately wasn’t an option because I have other health conditions and my pre-existing conditions would make it unlikely I could obtain new insurance in the future. I contacted NORD back in December to notify them of the discrepancy between Cephalon’s assistance policies and those implied on NORD’s website. I asked for their help or their clarification if I had misunderstood. 4 months later, I have yet to hear anything from NORD.

My neurologist was kind enough to give me samples which I now ration out for days when I absolutely must function. I can’t afford enough Provigil to work so I have been forced to apply for Social Security Disability Benefits (which I’m told will likely be denied). I’ve tried getting in on clinical trials but I don’t qualify. The thought of spending the rest of my life half-asleep and a burden to the people I love is so depressing I often think I’m better off dead.

Unethical drug companies have managed to take everything I’ve earned in my short 26 years of life and turn it into debt without any hope or means to get back on my feet. I don’t know about Genentech, but Cephalon certainly doesn’t care if their customers go without the product because of its cost. Cephalon has no interest in the well-being of the very consumers that support them.

We’re happy to post a response to this from Cephalon or NORD, if anyone from either of those entities cares to reply.