Tony Garr, the Executive Director of the Tennessee Health Care Campaign, has an op-ed today in The Tennessean. The Tennessee Health Care Campaign is a member of the Prescription Access Litigation coalition. We here at the PAL Blog aim to highlight the work of our coalition members.

In his op-ed (reprinted below), Tony challenges the Administration’s plan to cut the cost of the Medicare Part D drug benefit by charging higher premiums to higher-income recipients. He points out the absurdity of charging them more to save $640 million when $16 BILLION could be saved by ending the ridiculous overpayments to Medicare Advantage plans. The Government Accountability Office released a report yesterday, Medicare Advantage: Higher Spending Relative to Medicare Fee-for-Service May Not Ensure Lower Out-of-Pocket Costs for Beneficiaries. This report found that “Medicare spends more per beneficiary in Medicare Advantage than it does for beneficiaries in the original Medicare fee-for-service program, at an estimated additional cost to Medicare of $54 billion from 2009 through 2012.” Or, $16 Billion per year over that 4 year period.

Here’s Tony’s excellent op-ed. Food for thought:

Pay HMOs less to get real savings

By TONY GARR

A basic value that most Americans believe in is fairness. Most Americans are willing to pay their fair share.

However, imagine that on Oct. 1, 2008, people making more than $82,000 annually or families making more than $164,000 would begin to pay extra property tax so their children could go to public schools, or to pay an extra fee for police and fire protection, or to pay a higher fee for water and sewer services.

Lower- and lower-middle-income families would pay a base fee for these services, but higher-income families would pay extra. If such fees were really imposed, most Americans, even middle-income Americans, would be up in arms.

Recently, President Bush proposed that wealthier elderly and disabled Americans on Medicare pay higher fees to reduce the cost for the Medicare Prescription Drug Program, Part D. His proposal would supposedly save about $600 million per year.

$16 billion, or $640 million?

When Part D was created in 2003, it had been projected that Part D premiums and co-payments would not be adequate to fund the program. In fact, the current deficit for Part D far exceeds $600 million per year. The extra fees proposed by the president for wealthier Americans push more costs onto the Medicare beneficiary and do very little to slow the skyrocketing costs for this program. At the same time, the Medicare Advantage Plans (Medicare health-maintenance organizations) are making record profits.

If President Bush is really serious about controlling and reducing the costs for Part D, he needs to follow the money. According to the Congressional Budget Office, the Medicare Advantage Plans are being overpaid by as much as 13 percent, a figure that is increasing spending by more than $16 billion a year.

If the president is serious about real savings, there is no contest. Save $640 million a year by making wealthier Americans pay more. Or save $16 billion a year by paying the Medicare Advantage Plans less — the same as what is being paid for beneficiaries in traditional Medicare. The choice is obvious.

Our Medicare system is already too complicated. When we consider that Medicare serves our elderly parents and grandparents and others who have disabilities, all of whom may have difficulties completing more forms, then it is easy to see that our Medicare system needs to be simplified and not made even more complicated.

Already, the Medicare Advantage Plans can be a barrier to seeing the doctor whom we may want to see. Now, the president is asking wealthier Americans to pay extra fees. In the larger view of Medicare savings, Bush’s plan does not add up.

Follow the money and take “Advantage” of the real savings. This is where the real savings are — Medicare Advantage Plans.

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?

Representative Rose DeLauro (D-CT), chair of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, which oversees funding of the Food and Drug Administration, held an oversight hearing yesterday, “Improving the Drug Safety System at FDA.”

She made some strong and insightful comments in her opening statement at the hearing, which we excerpt below:

• A little over 100 years ago, Congress passed the Pure Food and Drug Act. With President Theodore Roosevelt, Congress passed this landmark legislation to protect the American people from adulterated and sham drugs and unsanitary and dangerous foods. Reading the newspapers today, with daily stories about unsafe food and unsafe prescription drugs, it is easy to wonder if we have gone back in time to 1906.
• Cases like this [the recent discovery of serious adverse reactions to a batch of the blood-thinner Heparin] or controversies surrounding Avandia, Vioxx, Trasylol and beyond — are embarrassing, but more than that they offer a window into the FDA’s myriad failures under the Bush administration. Its work motivated by ideology, compounded by incompetence, and negligence, and a lack of regard for the health and safety of the American public.
• To restore the agency’s gold standard mission and ensure the fundamental safety of the drugs it regulates, I am guided by four principles:
  • First we must increase funding to support the FDA’s mission.
  • Second, we must improve the management of the agency and hold it accountable.
  • Third, we must push back against the influence of Big Pharma over the agency.
  • Finally, and perhaps most importantly, we must let the scientists do their work, guided by science and not political interference.
• The FDA has been starved for resources under seven years of the Bush Administration. FDA managers point to a lack of resources as the reason for not carrying out their appointed duties. The administration is taking the bargain basement approach then using it an excuse for its poor performance…
• But increased funding is only part of the challenge. Funds alone cannot fix an agency that routinely fails at its most basic responsibilities: keeping track of clinical trials, preventing conflicts of interest, following up on critical investigations. Sixty-five percent of post-market studies on new medications have not yet begun. This startling fact makes it clear what a long way we have to go.
• Yet, in recent years, surveys consistently show that FDA scientists overwhelmingly complain about interference from top level FDA appointees on behalf of corporate and political interests. They feel that factors other than good science play a role in important FDA decisions. And that may be why too many good scientists continue to leave the agency at a time when we should trying to attract them and support their work.
• We can no longer accept federal agencies tasked to protect the public health that seem only interested in protecting business from embarrassment or cost.

On February 14, we reported that the Federal Trade Commission is suing Cephalon (NasdaqGS:CEPH) for paying off four generic drug companies not to bring a generic version of its sleepiness drug, Provigil to market. Several of our coalition members have been involved in a class action lawsuit against Cephalon for the same conduct for several years.

Today, Jon Leibowitz, one of the five members of the Federal Trade Commission, has an op-ed in the Washington Post, “This Pill Not To Be Taken With Competition: How Collusion Is Keeping Generic Drugs Off the Shelves” about the suit and its importance. Here are a few excerpts:

Cephalon was entitled to defend its patent in court. Instead, it fought back unfairly. The company paid the competing manufacturers more than $200 million in exchange for their agreements to keep their products off the market for nearly seven years. This payoff benefited the generic manufacturers enormously: They made more by sitting on their hands than they ever could have the old-fashioned way, by entering the market and competing. For Cephalon, too, the payoff was a bargain: Chief executive Frank Baldino Jr. acknowledged that it made about $4 billion “that no one expected.”

Who has to foot the $4 billion bill? Consumers, employers, insurers and the government — who have no choice but to pay the higher price for brand-name Provigil.

So while we are all forced to foot this bill, Cephalon is earning an impressive 2000% return on their “investment” of $200 million in paying off the generics. ($4 billion / $200 million = 2000%). This amply demonstrates that the loopholes the Courts have carved in Hatch-Waxman don’t just invite brand name drug companies to defend even what Leibowitz calls “infirm” patents and to pay off generic companies — they actively encourage such tactics – what pharmaceutical executive could resist a 2000% return on investment? Arguably these so-called “reverse payment settlements” are one of the best investments in pharma — perhaps even better than true research and development.

But this crucial benefit [of generics coming to market earlier] is threatened by a disturbing trend: the emergence of “pay-for-delay” settlements and the willingness of some federal courts to permit such obviously anticompetitive agreements. When these troubling deals first came to light in the late 1990s, the FTC fought them — and stopped them cold. Between 2000 and 2004, no brand and generic companies entered pay-for-delay deals; in other words, companies resolved patent disputes without anticompetitive payoffs.

Unfortunately, that success is under siege. Two federal appeals courts — in rulings that conflict with the analysis of a third appellate court — have found that a brand-name drug company facing a patent challenge is free to pay any amount to keep a generic producer from entering the market until the patent expires. These rulings depart from the spirit of Hatch-Waxman and our nation’s antitrust laws, and they harm consumers by subverting the competition at the heart of our free-market system.

One irony is that in one of these cases, concerning the prescription potassium supplement K-Dur, the Administration’s own Solicitor General sabotaged the Federal Trade Commission’s efforts to get the Supreme Court to review that case and this practice more broadly. (Here‘s the Solicitor General’s brief to the Supreme Court.)

Not surprisingly, after two courts blessed such payoffs, the frequency of these settlements has increased sharply. In fiscal 2006, fully half of all pharmaceutical patent settlements (14 of 28) contained such payments. Brand-name manufacturers, seeing the potential to continue reaping monopoly profits, have taken advantage of this apparent judicial leniency. Since some courts are allowing it, who can blame the companies? They have a duty to their shareholders to maximize profits.

Our case against Cephalon, which may ultimately reach the Supreme Court, will determine more than whether Americans taking Provigil are left to spend hundreds of millions of dollars more than they should for their medication. It will also determine whether the courts have effectively demolished the Hatch-Waxman Act and whether early generic competition will end altogether. If Cephalon prevails, generic companies will stop trying to be the first to compete; they will instead try to be the first to be paid not to compete.

And therein lies the case’s true significance.

Photo: CSEA President Danny Donohue joins childcare providers from CCPT-NY/CSEA and organizers in celebration of an overwhelming election victory.

PAL extends an enthusiastic congratulations to the Civil Service Employees Association (CSEA), a member of the Prescription Access Litigation coalition. Last year, Governor Spitzer (NY), signed an executive order giving home-based child care providers the right to union representation. Last week, with an overwhelming vote of 96% confidence, 17,000 child care providers formed a union and joined the CSEA/Child Care Providers Together – New York (CCPT-NY/CSEA). This victory means these child care professionals will be able to bargain for fair and timely pay, and the efficient delivery of State child care funding. Home-based child care workers provide affordable care to millions of children while their parents work. Yet too often such providers receive low pay and no benefits. Union representation improves their livelihoods and gives them a voice and the power to negotiate.

We are proud to welcome these 17,000 Child Care Providers to the PAL Coalition, through the CSEA!

In October 2007, we proudly announced that the parent union of PAL member United Federation of Teachers Welfare Fund also won a victory in having 28,000 home child care workers join its ranks. (See Archive for the ‘UFT’ Category Congrats to PAL member UFT Welfare Fund — 28,000 home child care workers join UFT)

Here is the CSEA Press Release:

17,000 Child Care Providers Vote to Join CSEA – UNION WINS LARGEST ORGANIZING ELECTION IN ITS HISTORY

ALBANY – 17,000 childcare providers across New York State voted today to form a union and join CSEA/Child Care Providers Together – New York (CCPT-NY/CSEA). In one of the largest elections ever conducted by, the New York State Employment Relations Board 96 percent of the providers voted to join CSEA.

“Today, 17,000 day care workers in New York added their voice to the national cry for change. They said the best way for working families to bring change is to form unions,” said John Sweeney, President of AFL-CIO.

Danny Donohue, CSEA Statewide President, congratulated the providers: “In joining the 7,500 licensed providers who have already joined our union, you now have the chance to change how childcare is provided in New York State.”

In the U.S., informal childcare represents half of all childcare for kids under the age of five whose parents are working.

“More than 65,000 child care providers joined AFSCME since 2005 to win rights and respect and be treated as professionals,” said Gerald W. McEntee, President of AFSCME, the largest child care union in the country representing more than 300,000 child care providers. “Today’s victory in New York is historic. This will help New York‘s 17,000 child care providers deliver the best quality care and early childhood education for our kids.”

The overwhelming election victory – 96 percent voting in favor of the union – means the providers have the right to negotiate with the State of New York to solve multiple challenges facing both providers and parents. Negotiations will be held with the NYS Office of Children and Family Services (OCFS).

For the providers, the biggest problems are more efficient delivery of county childcare funding, improving rates and on-time delivery of payments.

“We are excited to have our union so we make the changes needed to improve our work, get paid on time and care for the children,” said Sherriam McMaster of Albany, NY. McMaster has been a provider for just over a year.

Child Care Providers Together brings the total of unionized childcare providers represented by CSEA in New York to 25,000. In May of 2007, Gov. Eliot Spitzer signed and executive order granting home-based family childcare providers in New York State the right to union membership/representation. The executive order created 4 bargaining units. Units were subdivided into two in New York City and two covering the rest of the state. The teachers’ union (UFT) represents family providers in NYC.

The 2 units outside NYC are:

• License-exempt providers outside NYC. About 17,000 providers.
• Licensed group family and registered family providers outside NYC. About 7,500 providers.

Both are now represented by CSEA.

The organizing campaign had the support of the Rev. Jesse Jackson who helped with phone calls to the providers.

According to a recent release from the Bureau of Labor Statistics, union membership is seeing its biggest rise since 1983.

Consistent with this national trend, CCPT-NY/CSEA is not the first childcare union CSEA has organized. It follows in the footsteps of the recently certified VOICE (Voice of Organized Independent Child Care Educators), a bargaining unit of 7,500 registered and licensed providers outside of New York City. VOICE began negotiations with the NYS Office of Children and Family Services earlier this month.

The Boston Globe today ran “A line between docs and drugs,” an editorial that featured our colleagues at the Prescription Project. The editorial lauded academic medical centers that are implementing policies restricting the “freebies” and other marketing thrown their way in drug company attempts to influence their prescribing. Kudos to the Prescription Project for helping usher in these changes and to the Boston Globe for highlighting this growing trend!

A line between docs and drugs
February 25, 2008

Third in a series
PRESCRIPTION drug companies develop, manufacture, and sell powerful medicines. Academic medical centers treat patients and train physicians. Both the drug industry and the teaching hospitals play essential roles in modern medicine, but their functions need to be kept separate, as they will be under a policy recently unveiled by UMass Memorial Medical Center in Worcester.

Health insurance companies and state governments have encouraged physicians to prescribe generic products, and the rate of prescription drug inflation has diminished significantly. But keeping inflation down is a constant battle in healthcare. Academic medical centers, as shapers of physician opinion, ought to lead the way in protecting physician education from marketing by drug companies and their companion industry, the manufacturers of medical devices.

The UMass Memorial policy, up for final approval Wednesday, would prohibit hospital physicians from receiving gifts or meals from drug companies. Doctors wouldn’t be able to accept drug samples, which would instead be distributed by the central pharmacy. Donations to physicians for educational programs would be banned. Companies could contribute to a hospital fund for education or direct money to a department, but administrators would determine the content of the program.

This policy goes against a tradition of drug company largesse, but hospitals around the country are realizing that they can no longer serve as marketing adjuncts. In Massachusetts, a nonprofit coalition under the umbrella of the Prescription Project is shaping opinion to a strict standard. Last summer, Boston Medical Center adopted a policy similar to UMass’s, although physicians can partake of free food off campus if they “use discretion.”

Elsewhere in Boston, Tufts-New England Medical Center bans gifts, and, assisted by the Prescription Project, is working on a comprehensive policy. The Partners network imposes restrictions, but many can be waived by a department chief. Drug companies can offer informational meetings, with a meal if the food costs less than $20 per person and the chief approves. Samples can be accepted, if the program or department allows them, as can gifts worth less than $100. At Beth Israel Deaconess, a company can pay for food at seminars as long as the department approves. Doctors can get samples (for poor patients), and gifts, too, up to an annual $300 limit.

Partners, at least, is working on a tougher policy. Dr. Daniel Podolsky, its chief academic officer, cautioned, “We want doctors to know what is the best state-of-the-art care.” Drug and devices companies spend billions of dollars on marketing, and they’ll get their message out one way or the other. Hospitals need to make sure the information is not tainted by even a tiny bit of physician self-interest.

On Friday, we posted a press release from Breast Cancer Action (Breast Cancer Action: Patients Lose, Genentech Wins with FDA’s Avastin Ruling) criticizing the FDA’s approval of Genentech’s [NYSE:DNA] Avastin for treatment of metastatic breast cancer. We noted that it was odd that the FDA approved this drug, given that the Oncologic Drugs Advisory Committee (ODAC) had recommended. Applications for drugs to be approved for new uses are first sent to Advisory Committees comprised of physicians with expertise in that speciality (here, oncology). If the Advisory Committee recommends that the drug not be approved, the FDA usually approves it — and if it advises that it not be approved, then the FDA usually doesn’t. As an article in BioWorld Today (FDA Splits with ODAC, OKs Avastin Use in Breast Cancer) describes, the vote of the ODAC was close, but serious concerns were still raised by it:

The approval came as somewhat of a surprise, considering that the FDA usually follows the advice of its advisory panels. Although the ODAC vote on Avastin in breast cancer had been close, at 5 to 4, the panel had raised concerns about trial design, toxicity and survival data.

Breast Cancer Action raised some serious concerns about the FDA’s accelerated approval of Avastin for metastatic breast cancer in its press release which we posted on Friday. Barbara Brenner, Breast Cancer Action’s Executive Director, raises some additional concerns about the approval — not about the drug itself, but about how the drug was approved, and based on what type of clinical trial. In an email to advocates (reprinted here with her permission), she describes the danger:

I want to give folks some context for what happened here, particularly in light of the recommendation of the ODAC some weeks ago that the drug not be approved at this time. BCA encouraged that outcome. See the first story on the home page at http://www.bcaction.org/ for the history.

What happened today is that the Commissioner of the FDA, Andrew Von Eschenbach caved to enormous pressure from industry. Some of you have seen the Wall Street Journal editorial yesterday saying that it would be a “moral tragedy” if the drug weren’t approved because lives were at stake, even though there is no evidence that the drug improves survival. What we know is that the head of Genentech met with the WSJ editorial board last week. And they’ve been dribbling out little bits of data about other trials that also don’t have survival data.

The FDA Commissioner, as you know, is never bound by an ODAC recommendation. In this case, the Commissioner Von Eschenbach is as tied to industry as the rest of the Bush administration is.

As you can see from Genentech’s press release , we are very sad that that industry’s interests have trumped those of patients in the case of this particular drug, and that they have evidently acceded to a lower standard of drug approval — PFS (progression free survival) — instead of overall survival.

But the standard has been changed in another critically important way as a result of today’s decision. Before today, a drug could not be approved for marketing unless it had been subjected to a drug registration trial with standards set by the FDA. This standard is higher than the standard for classical clinical trials, largely because routine clinical trials often mask the true side effects of drugs or are done in populations that are likely to result in overstated benefit.

The decision made today was on the basis not of a registration trial, but of an NCI-sponsored clinical trial, not designed for drug registration. This means that, in the future, other drugs companies will be able to argue to the FDA (probably successfully) that the FDA drug registration standards don’t have to be met, basing approval on clinical trials will be just fine.

As I sat last week trying to figure out why Genentech had not even mentioned the AVADO trial (the one that was designed as registration trial, the results of which were expected in the first three months of this, and were in fact partially released last week, one week before the decision today) in their Avastin presentation to the ODAC in December, I came to a stunning realization: what Genentech was hoping for was a decision that would permit drugs companies to avoid the rigors of registration trials in the future, and rely on clinical trials that are often controlled by industry. And that is what they got with today’s decision.

The bar has been lowered in more ways than we can count. A very sad day for patients.

The BioWorld Today article described above gives some of the history:

In May 2006, Genentech submitted a supplemental biologics license application to the FDA seeking approval of Avastin in breast cancer. But the FDA raised concerns about the underlying data, which had not come from a traditional double-blind, placebo-controlled, company-sponsored Phase III trial. Instead, the sBLA was based on an open-label study, known as E2100, conducted by the National Institutes of Health-affiliated Eastern Cooperative Oncology Group. In September 2006, the agency delivered a complete response letter asking Genentech to audit the E2100 data in the same manner expected of a company-sponsored trial. (See BioWorld Today, Sept. 12, 2006.)

Genentech did as the FDA asked, resubmitting the revised sBLA in August 2007. But a second setback occurred in December, when ODAC narrowly voted against approval. (See BioWorld Today, Dec. 6, 2007.)

E2100 had randomized 722 previously untreated breast cancer patients to receive Avastin plus paclitaxel chemotherapy or paclitaxel alone. The study met its primary endpoint of improving progression-free survival (PFS): patients receiving Avastin achieved a median PFS of 11.3 months compared to 5.8 months for the control arm. However, there was no statistically significant difference in median overall survival, with the Avastin group surviving 26.5 months and the control group surviving 24.8 months, leading ODAC to debate the clinical merits of PFS.

The panel also raised questions about the design of E2100 once again and voiced concerns about adverse events. Six deaths were found to be ‘definitely or probably’ caused by toxicity related to Avastin, and 71.1 percent of patients in the Avastin arm experienced severe adverse events, compared to 51 percent in the control arm.

But between ODAC’s negative decision and the FDA’s positive one, data from a new Phase III trial became available. Known as AVADO, the trial was sponsored by Roche and properly designed. The randomized, double-blind, placebo-controlled Phase III study compared Avastin plus docetaxel chemotherapy to placebo plus docetaxel in the first-line treatment of 736 patients with locally recurrent or metastatic HER2-negative breast cancer. Avastin was administered at 15 mg/kg or 7.5 mg/kg every three weeks, and both doses resulted in a statistically significant improvement in PFS. [PAL Ed.: But not in overall survival, as Breast Cancer Action also pointed out in the trial upon which the approval was formally based] (See BioWorld Today, Feb. 14, 2008.)

Although the AVADO data were not officially included in the Avastin sBLA, Genentech submitted them to the FDA for consideration. That may have helped to sway the agency’s decision to go ahead and grant accelerated approval.

In its news release, Genentech said that converting its accelerated approval into a full approval will be dependent on an FDA review of the full AVADO data as well as data from a Genentech-sponsored Phase III trial known as RIBBON I. Initial RIBBON I data are expected later this year, while overall survival data from AVADO are expected around mid-2009.Genentech also plans to provide the FDA with data from three additional randomized trials that are either ongoing or planned.

So the question remains: Will FDA’s approval of a new indication based on a trial that was a not traditional double-blind, placebo-controlled, company-sponsored Phase III trial pave the way for the loosening of standards on what data the FDA will accept for approvals? Does the FDA’s overruling of its own advisory committee make it likely that the FDA will ignore its advisory committee recommendations more often? And what does the FDA’s approval of a drug based on a secondary endpoint like progression-free survival when the drug failed to meet the primary endpoint of overall survival bode for the future?

Got thoughts on these questions? Post ‘em in the comments.

PAL coalition member Breast Cancer Action today lambasted the FDA’s decision to grant accelerated approval for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer. Back in December, Breast Cancer Action had applauded an FDA Advisory Committee decision to recommend that the FDA not approve the drug for metastatic breast cancer. (See PAL member Breast Cancer Action declares victory as FDA denies approval for Avastin as a breast cancer treatment) The FDA normally follows the recommendations of its advisory committees, but of course is not required to.

Below is Breast Cancer Action’s press release on the issue. And here is Genentech’s press release on the approval.

PATIENTS LOSE, GENENTECH WINS WITH FDA’S AVASTIN RULING

San Francisco, CA ( February 22, 2008) —Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration’s decision today giving accelerated approval to biotech company Genentech’s application to market its drug Avastin as a treatment for metastatic breast cancer at this time.

“The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today’s decision is a victory for drug companies, but not for patients,” BCA Executive Director Barbara A. Brenner said.

BCA has long opposed Genentech’s application, arguing that no evidence has been presented that shows Avastin improves overall survival or quality of life.

In its application to the FDA, Genentech said that a clinical trial indicated that Avastin prolongs progression-free survival. However, BCA argued – and continues to argue — that that endpoint is meaningless because (1) it does not address the patient’s quality of life during those additional months, a very real question because of some of the serious side effects a number of the women experienced, and (2) it has not been shown in this case to correlate with overall survival. The data from another trial done by Genentech’s parent, Roche, has not been released, but it appears that it has the same limitations.

Breast Cancer Action is a national watchdog and advocacy organization that carries the voices of people affected by breast cancer to inspire and compel the changes necessary to end the breast cancer epidemic.

From the Department of Unsurprising News comes a report that PhRMA, the Pharmaceutical Researchers and Manufacturers Association, the brand-name drug industry’s lobbying arm, spent $22 Million lobbying Congress in 2007. This is a 25% increase from 2006. (Note: This is NOT the total amount that drug companies and their affiliated organizations spent on lobbying – it’s just the amount that PhRMA spent. If you include individual drug companies, the total would be much higher.)

That the pharmaceutical industry has become one of the largest corporate lobbies in the U.S. is not a new piece of news. The Center for Public Integrity reported in “Pushing Prescriptions” in April 2007 that:

• “Manufacturers of pharmaceuticals, medical devices and other health products spent nearly $182 million on federal lobbying from January 2005 through June 2006″
• “Of that total, drug companies and their trade groups spent most of it, or $155 million”
• “Drug interests employed about 1,100 lobbyists to do their bidding in each of the past two years [2005 & 2006].
• PhRMA “spent more than $18 million on lobbying last year, more than any single drug company and the most the group spent in one year since 1998, the earliest year of this analysis. In all, PhRMA has spent $104 million since 1998.“
• PhRMA “has an annual budget of more than $200 million.”
• Drug companies and their trade groups spent $733 million on lobbying from 1998 to mid 2006.

Pharmaceutical companies are also big contributors to Presidential, Congressional and Senate election campaigns. According to opensecrets.org, individuals who work for drug companies and drug industry PACs gave $11,084,395 to federal candidates in the 2006 election cycle.

What did the pharmaceutical industry get for its $22M investment in 2007? Says the AP article:

Proposals aimed at lowering drug prices and restricting industry advertising fell by the wayside in Congress…

The industry trade group advocated against:

• a proposal by House Democrats that would have allowed the government _ not private health insurers _ to negotiate drug prices for seniors in Medicare. The measure, aimed at wringing lower prices from drug makers, stalled in the House after President Bush threatened to veto it.
• legislation that would allow the U.S. to import cheaper prescription drugs from Canada and other foreign countries, citing safety concerns. Import proponents said foreign competition would help drive down U.S. drug prices. The issue failed to gain traction in Congress, despite several high-profile hearings.
• patent-reform legislation that it argued could weaken legal protections on drug patents. High-tech companies supported the bill that passed the House last year aimed at improving the U.S. patent system, but PhRMA argued it could weaken patent protections by reducing infringement penalties. The bill is still pending in the Senate.
• a bill overhauling the Food and Drug Administration’s drug-safety system. The legislation, which became law last September, gave FDA new powers to update drug safety labeling and monitor side effects after drugs are approved. But the final bill did not include restrictions on direct-to-consumer advertising opposed by the drug industry.

Not a bad return on investment. The passage of any of the measures that PhRMA’s cash helped defeat could have cost the industry billions, so a mere $22 Million seems like money well spent. Unless, of course, you’re a patient, a consumer, a taxpayer, a doctor — in short, anyone other than a drug company executive or stockholder.

To read the full AP story, go here.

We’re excited to announce the launch of a new regular feature on our blog, the PAL Coalition Member Spotlight. Here, we’ll be introducing you to our coalition members and giving you the opportunity to hear from them about the work they do and the pressing concerns of their members.

For our first spotlight we couldn’t think of a more dedicated group than the United Senior Action of Indiana (USA), an organization that has grown to include more than 17,000 seniors and over 100 senior clubs working together on issues of importance to seniors. United Senior Action mobilizes seniors to advocate on a broad range of issues, including nursing homes and community-based alternatives, utility and telephone rates, prescription drug prices, health care and more. They also link members and others to Rx for Savings, where consumers can safely order medications from licensed pharmacies in Canada and other countries.

Please enjoy our interview with United Senior Action of Indiana’s inspiring Executive Director Michelle Niemier.

PAL: What is the mission of your organization?

Michelle Niemier: Since 1979, United Senior Action (USA) has been uniting Indiana seniors and their families into a powerful voice to impact policies affecting our lives and our community.

PAL: What inspired you to become involved in the organization?

MN: If you are personally asking “me,” even after 19 years with the organization, I am inspired each and every day by the deep-felt passion our members have for justice and their willingness to take action on behalf of others. United Senior Action challenges the status quo making us immensely unpopular with those in power. Nonetheless, even those who wish United Senior Action would simply go away respect us as protecting our integrity is of utmost importance.

PAL: How does the high cost of prescription drugs affect your members?

MN: On the surface, most would conclude drug costs are of major importance to our members because they are older. In fact, however, I strongly believe seniors in this country would be willing to continue sacrificing (skipping doses, not buying groceries, struggling to pay their utility bills) by paying exorbitant prices if they truly believed that, as a result of their sacrifice, more research and development would be done. Our members do not want their grandchildren and great-grandchildren to face Alzheimer’s disease, cancer, heart disease, etc. However, as we all know the high costs Americans pay for their medicines is certainly not going predominantly to research and development. This fact angers seniors to the point of near revolution.

PAL: What is one thing you think should be done to change the way drugs are priced or marketed?
MN: Safe importation of medicines from countries with as good or better safety requirements would dissolve the stranglehold drug companies have on all American consumers. Even better, accessing the world market would not cost consumers a dime. Unlike Medicare Part D, which will cost our members’ grandchildren $800+ billion.

PAL: What does your organization do to educate your members about prescription drug issues?

MN:As an activist organization, our members use grassroots networks (retiree groups, churches, health fairs, etc.) to educate members about prescription drug issues. Our newspaper, The United Senior Advocate, has a well-earned reputation for fair and timely information and is our top means of calling members to action.

PAL: How does litigation play a role in your organization’s fight against Pharma’s illegal pricing schemes?

MN: Litigation is an effective organizing tactic for our organization. While our members would prefer that drug companies would just “wake up and change their ways,” we know they won’t without public pressure. PAL lawsuits are grounded in legal and public policy, making those actions effective.

PAL: What are some of the most pressing needs of your members?
MN: As with all grassroots organizations, our limited resources often leave us isolated from similar organizations around the country. Through the PAL project, United Senior Action members are able to stand together with action-oriented, risk-takers, thus giving USA members a stronger, louder voice.

To learn more about USA, visit their website.

If your organization is one of the 130+ that are members of the PAL coalition, and you’d like to be featured in a PAL Member Spotlight on the PAL blog, please let us know. If your organization is interested in joining the PAL coalition, go here for more information.