AARP’s Slick New Agenda

The entity formerly known as the American Association of Retired Persons (now doing business as AARP) has launched a slick new policy agenda. And their target isn’t older Americans.

AARP has been spending major money lobbying for the passage and signing of the SCHIP bill and this strikes me as particularly odd. Today, AARP has mobilized its billion dollar lobby machine to get the children’s health bill signed by Bush. The organization has even reached out to former foes to sign on to the mission. In short, it is the kind of push AARP usually reserves for entitlement programs for older Americans.

What’s up?

It reminds of AARP’s new multi-million dollar ad campaign targeting children and young adults. AARP’s message is, “We’re not the enemy. We want to help you.” AARP is promoting a campaign called Divided We Fail, or as my neighbor puts it, “United to Screw Our Grandkids.” Actually, we’ve been screwing our grandkids for a long time, but AARP’s mission is to keep them from realizing it.

The premise is based in reality—entitlement programs that AARP has been lobbying in support of for over 50 years are bankrupting our children and grandchildren. When social security was put in place, there were 12 workers for every retiree. Today that number is 2 (and falling fast). Retirees are receiving more money out of the system than they ever put it (two to three lifetimes worth). And the young people contributing today will never see a penny as long as AARP remains steadfast that it will not allow the retirement age to be increased or benefits to be decreased. Meanwhile, those social security checks spend 5 minutes waiting on line before boarding buses every day to make the 90 minute trip to Atlantic City.

AARP is desperate for younger Americans (i.e., those contributing to society) to not see us as the enemy. And we are. The Greatest Generation and the Boomers have done tremendous things with our lives. But it doesn’t entitle us to write a blank check on our children and grandchildren. In essence, we are making them indentured servants and they don’t even know it. This is Bill Novelli’s legacy.

And this is one of the reasons why I’m not an AARP member.

Novartis’ Prexige is KO’d

No surprises here, the FDA officially issues a “not approvable” letter for Novartis’ Cox-2 inhibitor, Prexige. See Novartis press release.

Novartis CEO Daniel Vasella all but threw in the towel on Prexige back of September 12.

Bigfoot, Elvis and Thimerosal

The three great myths that will not die: Bigfoot, Elvis’ perpetual longevity and the vaccines/thimerosal/autism link.

Yet another nail in the coffin of the vaccines/thimerosal/autism myth was delivered today in the form of a CDC study published in the New England Journal of Medicine. (See the NEJM study and the New York Times article). Also working on the study were Harvard Medical School, Stanford University and Kaiser Permanente.

Ironically, while initially supporting the research (Sallie Bernard, Executive Director of SafeMinds helped consult on the trial design and protocol), anti-science organizations pulled their support when the data didn’t support their agenda. For those unfamiliar with the scientific method, generally, you observe the world around you, you develop a hypothesis based on those observations, you then test and study the hypothesis, and finally, evaluate the outcome. And if the outcome doesn’t support the hypothesis, you do two things: 1) check the data like we’ve doing for several years and 2) question the hypothesis. No scientific method for theses groups…

From what I’ve read in the literature, the link between a mother’s consumption of alcohol during pregnancy and autism is a plausible area of study. Now, I’m not saying that all cases of autism are cased by mothers drinking during pregnancy and the last thing that I am advocating is a “blame the mothers” campaign. However, enough evidence does exist that this should also be studied. I understand there is less money in it for the families and their trial lawyers, but it is a legitimate avenue for scientific inquiry. If these families are really interested in understanding what causes autism, this is an area that should be investigated.

Autism is a real disease that terribly impacts the lives of real children. It’s a shame that groups would rather spend money squabbling instead of devoting those resources to actually helping their children.

FDA Warns on Cephalon’s Fentora

The FDA warned yesterday afternoon about serious adverse events with Cephalon’s Fentora, including death. See the FDA warning.

The adverse are associated with substitutions from Cephalon’s other breakthrough pain drug, Actiq, improper dosing of Fentora and improper patient selection. Cephalon will need to beef up its warnings on the product. The future of Fentora will rest in whether the Cephalon can actually get physicians to comply to with dosing instructions and labeling.

Follow Up to J&J’s Legal Stent Strategy

Yesterday, I received a comment to my piece on the J&J/Boston Scientific legal battle that was worthy of a more thoughtful reply. I received a cogent and articulate response from someone claiming to be Christopher Allman with J&J’s Cordis. I use the term claiming because the response so timely that I was immediately distrustful that it actually came from J&J. But sure enough, there is one communications person at a J&J company who is on his game.

My original posting was particularly negative towards J&J…a company that hasn’t been in my favor recently for their PR disaster with the American Red Cross. Seeing J&J execute a similarly bizarre legal strategy, I commented on it without the full benefit of fact. To be completely fair – I have not yet had a chance to get into PACER and actually review the legal documents on this case (something I normally do before writing on legal issues), so I went on the Times story as background. For commenting before I had more thoroughly reviewed all relevant materials, I apologize.

In the interest of balance, I am reprinting the J&J Cordis statement below (sorry I can't get the formatting right):

Just some additional thoughts to your piece.

One of Judge Robinson's rulings yesterday concerned a Boston Scientific patent for a stent coating that the inventor claims is non-thrombogenic. That means it theoretically prevents thrombosis. Since thrombosis has been demonstrated to occur with all currently marketed stents -- bare metal and drug-eluting from all manufacturers -- we hold that no currently marketed stent could be infringing a patent for a non-thrombogenic coating. That's why we intend to appeal.

The drug-coating process at issue in this case is not in use by any manufacturer at this time, nor has it ever been.

Cordis argued at trial that any drug-eluting stent for which thrombosis has been demonstrated can't infringe a patent that claims a non-thrombogenic coating.

We lost at trial and made a motion for that decision to be overturned as more data were presented that confirmed that thromboses do occur with drug-eluting stents, both Cordis' CYPHER Sirolimus-eluting Coronary Stent and Boston Scientific's Taxus.

This week's ruling by Judge Robinson denied that motion, and we are disappointed because we continue to hold that we are not infringing a patent for a non-thrombogenic coating. We expect to argue for that position on appeal.

Our legal strategy in this case is not inconsistent with any position we have held in any other venue.

We continue to believe that the CYPHER Stent offers important advantages in terms of efficacy and safety over bare metal stents and the Taxus stent when used in appropriate patients. A growing body of clinical evidence supports this position.

Thanks

Christopher Allman Cordis Corporation

J&J’s Stent Legal Strategy

No, this isn’t another article about Johnson & Johnson’s strategy to sue the American Red Cross. I’ve questioned J&J’s legal strategy (not to mention their Communications preparedness) in other articles, but this one just baffles me—

To defend itself against a patent infringement case, J&J’s legal argument is that its product has safety issues. No, this isn’t a joke. Read “Johnson & Johnson’s Risky Tactic Fails in Patent Fight” in yesterday’s New York Times.

It goes like this: Johnson & Johnson “lawyers hoped to persuade a federal judge in Delaware that because Johnson & Johnson’s drug-coated Cypher stent had been linked in clinical studies to blood clots, it fell outside the safety profile of a Boston Scientific patent.”

In other words J&J is telling doctors and patients one thing and something else to the courts: “That position appeared to contradict Johnson & Johnson’s repeated assertions in its communications with doctors and the public in the past year that Cypher is no more likely to induce clots than older bare-metal stents.”

And in plain English: There are more safety concerns with our product, so we obviously didn’t violate their patent. I can’t wait to get my hands on the court transcripts!

The J&J lawyers should be commended for their honesty.

Damning the FDA

This morning’s Wall Street Journal carried a gem of an OpEd “The FDA vs. Small Pharma.” Some independent pharma companies have been harping on their regulatory situation and finally got the Wall Street Journal to take the bait.

Here’s the premise—there are hundreds (and perhaps thousands) of drugs in America that are sold and have never actually be tested on patients or gone through clinical trials of any kind. They Wall Street Journal dubs them “legacy” products that were allowed in under an antiquated monograph system at the FDA. The drugs are BELIEVED to be generally safe and effective, but nobody really knows. Adverse events reporting for these older medications (including some OTCs) aren’t tracked very well compared to new drugs like Avandia and Lipitor.

In the post-Vioxx era of hyper-safety concerns, the FDA has been pulling these drugs from the market once there is a version that has gone through trials and actually demonstrated safety and efficacy. The Journal rightly indicates that the FDA’s action against these unapproved drugs has a disproportionate impact on “small pharma.” I’ll agree with the Journal that this has a tremendous impact on small companies, but let’s not overstretch by calling some of these companies “pharmas.”

The FDA is really damned if they do and damned if they don’t. For year’s, anti-innovation advocates like Dr. Sidney Wolfe have been criticizing the FDA to do more to ensure patient safety. Now that the FDA is doing it, they are criticized by the pro-business camp as going too far. There needs to be a happy medium, but the FDA hasn’t reached it yet.

Earlier this week there were protests at the FDA decrying the agency’s decision to withhold Provenge (and other cancer therapies) from patients. The FDA chose to listen to a minority of physician advisory panel members with a financial interest in keeping a new cancer therapy away from patients – doctors whose mantra is “what’s in it for me?” and not “first do no harm.” Can the FDA continue to allow unapproved quinine on the market? Sure (and I’ll continue drinking it in my gin and tonics). Has the FDA overstepped in the interest of patient safety? Probably.

Peter Rost Weekly Book Sales Update

Over the last week, sales of Peter Rost’s Killer Drug moderated again. Overall sales ranking for Killer Drug is now down to 468,777 (down from 340,559 at last update).

Sales of Petey’s first book The Whistleblower have been fairly constant over the period. Overall sales ranking is now 214918 (up from 268,622 at last update).

Johnson & Johnson Moves to Profit on Clara Barton Name

It is rumored that Johnson & Johnson is planning to expand its profiteering plans against the American Red Cross and Clara Barton.

J&J is rumored to be planning a toll plaza at the entrance to the Clara Barton Parkway outside Washington, D.C. Tolls for passenger cars would be $4.00, but living up to its Credo, the company will graciously donate a box of Hello Kitty Band-Aids to all drivers. There is a one-box per week limit and drivers must also sign an agreement promising not to complain about having to pay the toll. If drivers are found to have complained, J&J will file lawsuits against them too.

However, in good news for New Jersey drivers (no, your car insurance rates won’t go down), but J&J has decided against taking over the Clara Barton Service Area on the New Jersey Turnpike. Early plans called for raising the price of a Nathan’s Famous hotdog to $24 (or $32 if you don’t have insurance).

Cancer Patients Protest FDA

Yesterday patients protested their right to live at the FDA. Sponsored by A Right To Live, the event was more than a protest over the FDA’s bungling of Dendreon’s Provenge. As the FDA has slowed drug reviews and approvals to a snails pace in the interest of “patient safety,” cancer patients are suffering and dying.

As the conflicts of interest among the Provenge reviewers has become more apparent, the FDA is left holding the bag for a bad decision. But in the current environment of being tough on patient safety, the FDA won’t acknowledge a mistake.

Since when did “do no harm” become “not obliged to help,” or even worse, “what’s in it for me?”

ClintonCare Part II

Are we ready for ClintonCare Part II?

14 years after the failed ClintonCare, we’re still living with the consequences. The only piece of ClintonCare that Hillary Clinton was able to get through was a piece of legislation called the Vaccines for Children program. Among other things, it cut reimbursement for childhood immunizations.

Thing it’s a bunch of Republican propaganda? Even the left-leaning New York Times and Congressional Democrats agree Hillary’s Vaccines for Children program (a.k.a., ClintonCare) was a bad, bad idea. That was back in 1995, two years after the Clinton’s ill-conceived program was implemented.

Ironically, Hillary touts the failed Vaccines for Children program (although she doesn’t actually use the name) as one of her healthcare accomplishments. 14 years after Hillary’s failed Vaccines for Children program, childhood immunization rates are flat or declining (depending on the vaccine). And Hillary is proud of this? Somewhere along the way she confused MMR with her Botox.

What has changed? Not much. Today’s AP story indicates that there is a near crisis in people getting flu shots. Those that need the shots most aren’t getting them. Influenza kills about 36,000 Americans a year.

This isn’t something Hillary should be proud of.

Why EMR’s Aren’t Going to Fly (Anytime Soon)

The other day I was talking with a woman who had just switched her physician. She complained about the process of getting her records and she felt that her old physician was dragging his feet.

Her switch was prompted by a move, not dissatisfaction. However, she felt that she had betrayed the doctor and that, in turn, he was punishing her. And she’s probably right.

And this is the single biggest reason portable electronic medical records/electronic health records will never fly. Most physicians won’t embrace it. EMRs will lower the rather significant barriers physicians have constructed to maintain their patient base. Lowering the switching barriers will empower consumers, something that physicians don’t want (see Physician Takes Aim At First Amendment).

EMRs will surely benefit patients through greater choice, better transparency and the ability to catch physicians’ prescribing mistakes. But as long as physicians perceive the risk to their revenue stream, patient convenience and patient safety will take a back seat.

I can’t think of any other industry where the consumer (the patient) takes a back seat to the vendor (the doctor).

HHS Has More Meetings with China

Mike Leavitt has sent Rich McKeown back to Beijing to get tough on food and drug safety. I think it’s great that HHS is finally getting engaged (the warning signs about “the China problem” have existed for years). But talk is cheap.

The United States-China Bilateral Meetings on Food and Drug Safety are great. But meetings don’t make things safety and unless China steps up to enforcement plate, whatever agreements come out of these meetings will be a joke. The execution of the former FDA chief in China was a very visible token gesture, but the publicity is not a replacement for meaningful reforms in China.

J&J Expands Red Cross Lawsuit

While I was out at the lake, I bumped into the J&J comms team on vacation again.

While they were on vacation, a rogue lawyer has expanded the lawsuit to include other organizations trespassing on J&J’s trademarked red cross. Those added to the lawsuit include:

• United Kingdom


• The Episcopal Church


• Faroe Islands


• Iceland

Stay tuned…

Thinking Through Universal Health Care

I was surfing some websites and found this unique take on universal health coverage:

The CEO of the Council on Aging of Sonoma County (CA), Shirlee Zane (pictured at right), is advocating for universal health coverage. Great, but looking more at some of her statements gave me pause.

She makes a statement regarding private companies in the insurance business and says, “It is no surprise that we pay more for health care than any other country in the world with that kind of obscene profit margin.” Perhaps. I wouldn’t know and she doesn’t actually offer the sources behind her statistics. However, there is a second part of the equation in countries with socialized medicine: rationing care. (That means no more plastic surgery or Botox for her Sonoma County friends.)

Universal coverage sounds great. And it is… But only partially. For preventative care and basic services, it is fantastic. But what proponents of universal health coverage like Shirlee Zane forget to mention is that universal health coverage does not equate to unlimited health coverage. All countries with socialized medical systems ration or restrict care. If you are over 50 in the UK, you better not need a transplant of a major body organ. Over age 60 and develop cancer in the EU? You got a problem. And it’s not just vanity products like Viagra and Cialis for erectile dysfunction. Got cancer in Canada and want access to a drug that could save your life? Good luck, the government won’t pay for it.

In Canada, over half of Canadians have paid for services outside of the Health Canada system. Why? If universal coverage is so great in Canada, why would a Canadian dip into his or her own pocket and pay for something? The answer is that some services are not covered or not covered in a timely fashion. Canadian’s love their universal health system…and they also hate it (Michael Moore left that part on the cutting room floor). Just ask them.

Zane makes the statement, “Another “myth” that has long been circulated is the myth of waiting for procedures. A recent study demonstrated that if you have a serious disease, such as cancer, you will wait longer for surgery in the United States than you will for surgery in Canada. The wait for elective surgeries in Canada is longer, but then again, those are not life-threatening.” Naturally, she offers no supporting reference to document her claims. Her are few reputable sources that contradict her: Health Canada (official government site), Canadian Institute for Health Information, Frazer Institute’s Waiting Your Turn (biased, but still good), and others. There’s also a mountain of legitimate media coverage in Canada documenting that this is not a myth (including for cancer, where cancer patients in Ontario wait longer for basic care like radiation than U.S. citizens just across the river in Michigan).

Here’s the real problem with universal health coverage—advocates like Michael Moore and Shirlee Zane are hyping the benefits to the point that whatever reality is eventually implemented, it is bound to disappoint. Like any other country, the United States will need to place limits on “universal health care.” Setting expectations so high that no system will meet them is bad for everyone. Advocates for universal coverage like Shirlee should tone done the rhetoric and talk up the facts.

SSRIs and Suicide

Since the FDA warned in 2003 that SSRIs might lead to suicide ideation and possibly even suicides in adolescents, there has been considerable controversy over link (and an extreme amount of emotional hype).

A new study finds that since the warnings were placed on SSRIs in 2003 (and doctors scaled back prescribing), the number of suicides among adolescents jumped 14% in one year. There’s no conclusive proof that the drop in antidepressant usage is causing the suicides, but the relationship is clear (and no other explanations can be supported by the data).

The study is likely to bring the anti-science crowd out in full force.

MedAdNews Most Admired Companies

MedAdNews is conducting its annual survey on the Most Admired Companies in the pharmaceutical industry. The deadline is midnight on Monday, September 10. Vote for your favorites at MedAdNews.

State of New Hampshire Appeals Drug Data Decision

The State of New Hampshire has gone “all in” and decided to appeal its defeat on health care data. Earlier this year, Judge Paul Barbadoro struck down the law as being unconstitutional.

The state Attorney General Kelly Ayotte has said that the law protects physicians from pharmaceutical marketing and helps contain health care costs. In his 54-page ruling, Judge Barbadoro indicated that there were less invasive ways to manage health care costs, including many options not considered by the state. The Judge also noted that physicians already have the ability to shield themselves from pharmaceutical marketing through common sense (Docs can just so no – if a six-year-old child can do it, docs can too).

As I covered back on May 3, 2007 in Health or Hubris? – NH Appeals Judge’s Data Decision, the Attorney General Kelly Ayotte said, “The Prescription Information Law protects the state’s interests and the interests of New Hampshire’s physicians and citizens, which strongly outweigh the pharmaceutical industry’s interest in increased profits.” Evidently Attorney General Ayotte missed the trial because it wasn’t the pharmaceutical companies that the law targeted and nothing in the law was actually going to reduce drug costs. [I’ve previously discussed data and drug costs in Doctor Data and Pharmaceutical Costs.] During the time the data was blocked in New Hampshire, no effort was made by the state to actually reduce drug costs.

This seems to be about certain physicians in New Hampshire who are concerned that their prescribing behaviors will come out. What prescribing behaviors? Prescription narcotic abuse is a huge problem in New Hampshire – a problem that is enabled by certain doctors in the state (see New Hampshire Prescription Drug Abuse). Representative Cindy Rosenwald told The New Republic magazine she proposed the legislation on behalf of her husband, New Hampshire Cardiologist Dr. Peter Klementowicz.

The District Judge’s ruling seems solid and the State of New Hampshire has already agreed to all of the statements of fact in the spring. Can the citizen’s of New Hampshire afford another costly legal battle, having just lost one? I guess so…

Peter Rost Weekly Book Sales Update

Over the last week, sales of Peter Rost’s Killer Drug moderated again. Overall sales ranking for Killer Drug is now down to 340,559 (from 175,504 at last update).

Sales of Petey’s first book The Whistleblower fell considerably since last update. Overall sales ranking is now 268,622 (down from 91,501 at last update).

A note on methodology—I don’t have great Internet connectivity out at the lake, so I’m missing quite a few data points over the last week.

Note: I have received comments and e-mails asking why I continue to do this. I write about Peter’s book for one simple reason: he sent me several e-mails begging me to write about it. So I oblige.