Tuesday, July 31, 2007

The Verdict is in on Part D


IMS Health today published results of a study analyzing the impact of the first year of Medicare Part D. Highlights include:

  • 6% of Medicare beneficiaries entered the donut hole, with most of them coming in the third and fourth quarters of 2006
  • Participants in Part D plans filled 486 million prescriptions; 15% of all retail prescriptions
  • Uninsured seniors reaped the greatest rewards, saving on average 60% compared to the prior year
  • In the 12 classes studied in the IMS report, patients who reached the donut hole continued therapy after coverage was suspended
  • Generic utilization in Medicare was more than the rest of the market (generics account for more than half of all prescriptions in both groups)
The Part D program accomplished what it set out to – provide prescription drug coverage to those seniors who wanted it. The IMS Health report can be found on the IMS website.

Ranking Your Doctor


As my initial posting, Physician Takes Aim at First Amendment indicated, there are physicians in this country that don’t want patients to be informed. I’ve been fascinated by this physician rating business for the last few weeks.

As background, I first wrote about this on July 6 because Dr. Jeffrey Segal and his Medical Justice Service company has launched a contract program to deny patients medical care unless they agree to the terms of the contract (namely, not to rate him as a physician). In a media interview, he said that patients are so ignorant that, “I’m not even convinced the patient can properly characterize a physician fairly.”

Dr. Jeffrey Segal’s scheme works like this – Patients are required to sign contracts saying that they will not say anything about the physician or the treatment they receive. In exchange for which, the doctor will actually treat the patient. There’s an interesting twist in the contract in which, if the patient signs, the doctor also agrees to abide by HIPAA regulations and not sell the patient’s personal medication information to marketers. (Segal “sells” this to patients by claiming he’s “giving” the patients additional privacy protection above the law.) If patients are confronted by their physician with a contract, they should find another physician.

After my initial posting, I was contacted by Steve Feldman, MD, Ph.D., who takes a different approach – DrScore.com. Rather than believing patients are ignorant and should be kept in the dark, Dr. Feldman has launched a different firm, which engages both patients and physicians in a dialogue about their care. Enlightened physicians tell their patients about the DrScore.com website and the patients provide evaluations based on both quantitative and qualitative metrics. Over the past few weeks, I have spent some time on the DrScore website and have rated a number of my personal physicians.

Patients benefit from DrScore by finding physicians that have been positively reviewed by other patients (similar to other). Physicians also benefit by getting feedback on their practices and can make changes. As an example, one of the questions asks about the front office staff (physicians can “see” a part of the patient’s experience that they normally don’t see). Another question asks about the quantity and distance of parking. DrScore is an absolutely fantastic service and I think patients should take advantage of it.

The more I have explored this, the more out-to-lunch Segal and the medical extortion service seem. The notion of evaluating physicians is good for both the patient and the physician. The idea of physician evaluations supports an open, transparent healthcare system. It would seem to me that if these private enterprises like DrScore are marginalized, a more concerted government approach to evaluating physicians could be suggested. Something to think about.

Disclosure: I have no relationship, financial or otherwise, with DrScore.com.

Provenge – The Companies and the PR Firm


Pharmalot’s Ed Silverman is reporting that a group called Care to Live filed a federal lawsuit against FDA commissioner Andrew von Eschenbach and FDA advisory panel member Dr. Howard Scher of Memorial Sloan Kettering. It its complaint (found here), Care to Live outlines allegations of conflicts of interest beyond the scope of a normal FDA review.

While nothing new (these claims are all over the internet) and I have discussed them in Behind the Scenes of Provenge, this certainly takes the battle over Provenge to a new level. To recap, Dr. Howard Scher, who maintains a financial/consulting interest in rival firm Novacea, voted to reject Provenge (along with Dr. Maha Hussain, who also maintains a financial interest in Novacea) just weeks before Novacea closed a near billion dollar deal with Schering-Plough—a deal that, according to a banker at Morgan Stanley, could have been worth less had Provenge been approved. Was this a conscious torpedoing of Provenge for financial gain or merely the most remarkable coincidence of timing known to modern man?

Rather than recap all of this, what I want to focus on is the very quiet PR firm in the middle—WeissComm Parnters. The company has worked with both Dendreon and Novacea in the past (although refused to disclose its current relationship with either firm). Given Ruder Finn’s rather high-profile embarrassment of its client Novartis last week, it’s interesting to see WeissComm take a decidedly different approach—clam up and go black.

The questions I’ve asked (and have not received an answer on) are: What role, if any, did the PR agency have in the days leading up to the advisory committee hearing? What information, if any, may have been shared between the two companies via the agency? Did WeissComm orchestrate a call or meeting on behalf of Novacea to “brief” either Drs. Scher or Hussain prior to the Provenge advisory committee hearing? Has WeissComm paid any consulting fees to either Drs. Scher or Hussain on behalf of Novacea that may not show up as direct payments on behalf of the company? I don’t know if WeissComm did anything inappropriate or not. But there are many, many unanswered questions and this agency could be in a position to provide some answers.

The review of the decisions behind the scenes of the Provenge review and the rather unique relationship that Drs. Scher and Hussain have with a rival firm will be an interesting area to watch unfold.

And Avandia Stays…For Now



Yesterday, an FDA advisory panel recommended 20-1 that GSK’s Avandia remain on the market. The same panel also acknowledged that Avandia does have serious cardiovascular complications. So new warnings, but not a complete withdrawal.

Monday, July 30, 2007

The Role of the PR Firm


Usually, companies employ a public relations firm for two reasons: get good publicity and avoid bad publicity. So last week left me scratching my head.

Novartis, like most companies, employs a PR firm in the U.S. They have chosen Ruder Finn in New York. Usually, a company’s choice of PR agencies isn’t very public. Yet, when Novartis faced a whistleblower suit last week, Ruder Finn couldn’t figure out which end was up. More importantly, they couldn't figure out how to get out of the way. (see Jim Edwards' Novartis and Olagunju: A Case Study in Pharma PR and Media Failure).

I would imagine Novartis CEO Daniel Vasella has got to be cringing at this instance where the company and its agency tripped all over each other.

The Week Ahead – July 30-August 5

July 30 – FDA Drug Risk Review – Avandia: Health and Human Services Department (HHS); Food and Drug Administration is holding a joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone (Avandia), as presented by FDA and GlaxoSmithKline.

July 31 – FDA Drug Safety Review – TYSABRI: Health and Human Services Department (HHS); Food and Drug Administration are holding a meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss TYSABRI (natalizumab) biologic license application (BLA) 125104/33, Biogen Idec, Inc., for the proposed indication of inducing and maintaining sustained response and remission, and eliminating corticosteroid use in patients with moderately to severely active Crohn's disease with inflammation, as evidenced by elevated C-reactive protein level or another objective marker. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of moderate to severe Crohn's disease, and proposed risk management plan.

August 1 – Health Affairs is holding a briefing – “Portable Health Information: Are We Any Closer?” The Santa Barbara County Care Data Exchange was one of the most ambitious and publicized health data collection experiments in the country. But 10 years after its inception, the project failed. At a time when the United States is seeking to expand the use of interoperable health information technology (IT) through regional data exchanges, what lessons can be learned from the ground-breaking Santa Barbara experiment, and how will they guide future health information technology efforts.

August 1 – Dermatologic and Ophthalmic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting of Food and Drug Administration, HHS. The committees will meet in joint session to be briefed on iPledge, the risk management program for isotretinoin products (a.k.a. Accutane; originally from Roche).

Friday, July 27, 2007

FDA Admits Zelnorm Mistake (Almost)


The FDA partially reversed its decision to yank Zelnorm from the market (for background see FDA Announces Drug Withdrawals). In a press release earlier today, the FDA announced that “it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol” for the most serious of patients. These are the same patients the FDA refused to acknowledge actually exist back when it removed the drug back on March 30.

The Zelnorm debacle is emblematic of the current situation at the FDA – decisions are being made based on political pressure, not science. There is no longer any consideration given to the risk benefit profile of a product and the potential benefits to patients. The pendulum has swung from one dangerous extreme to the other.

As I mentioned at the time, Novartis’ Zelnorm got yanked because of a minor, and NOT statistically significant, sub-population in an 18,000 person study. 13 people out of 11,614 (or 0.11%) had an increase adverse cardiovascular events. Every one of the patients had pre-existing cardiovascular disease and risk factors (i.e., the doctor never should have put them on the drug in the first place).
I’ll be the first to admit that Zelnorm was personal for me. I have a very close friend who has lived for years with debilitating IBS. Zelnorm was a miracle drug for her and allowed her to live her life…a normal life. She spent four months suffering while the FDA played politics instead of science. I guess she owes a big thank you to Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research for her suffering. Thanks Steven. Good job, you win the gold star.

Let’s make it clear, Zelnorm is only back for the most serious of patients. The FDA has too much at risk politically to admit that the Zelnorm decision was a total farce and allow the product back. Again, it is the FDA putting politics before patients.

Thursday, July 26, 2007

China’s Olympics Hit Food Safety Snag


Increasingly, people traveling to China have food safety on their mind. Once hidden from view and not reported by the state-controlled media, China’s food contamination problems became big news its exports have been linked to deaths of people and animals in other countries. The recent deaths of thousands of dogs in the U.S. and other countries has been traced back to China. As a May 17 article in the International Herald Tribune proclaimed: 'Made in China' becomes known as 'Buyer Beware.'

China has all but admitted there is a problem. Three weeks ago, the government took the draconian step of executing the former head of its food and drug administrator, Zheng Xiaoyu. China claims the step demonstrates that it is serious about food and drug safety.

China will host the 2008 Olympics and is desperate to propel itself into the international spotlight. Nothing short of perfection is expected in Bejing. The question must be asked – How will these problems affect the Chinese Olympics?

With the cloud of food safety hanging over the country, travelers to the Olympics should be prepared to be self-sufficient. Several companies that currently sell freeze-dried food to backpackers and campers are planning to offer Olympics travel products. These packs will enable travelers to the Olympics to be entirely self-sufficient and not risk exposure to unhealthy food. Watch for more on these products in the fall.

The Bejing Olympics is China’s one big shot to throw of the baggage and join the modern era. But can it?

AZ Announces More Layoffs


AstraZeneca has more than doubled the number it plans to eliminate by 2010. Currently 7600 heads in the U.S. and Europe are on the chopping block. The company hopes it will save almost a billion dollars a year through the employee reductions.

The announcement comes on the heels of AZ’s second-quarter earnings, which declined dramatically on charges related its questionable acquisition of MedImmune (see AstraZeneca Buys MedImmunune, Huh?).

Given AZ’s state of affairs and the recent wave of pharma CEO turnover, one has to wonder if might see CEO David Brennan as one of the 7600 layoffs.

Monday, July 23, 2007

Roche CEO to Step Down


Last week, Roche announced that its CEO, Franz Humer, will be stepping down at its annual meeting in March. At least in the U.S., the announcement came as a major surprise. Imagine a CEO stepping aside for reasons other than shareholder revolt, failed R&D projects or major investigations.

Humer will be replaced by the former head of Roche Diagnostics, Severin Schwan, while Franz Humer will stay on as Chairman. Splitting the roles has been increasingly common in the U.S., but few expected the announcement to come so quickly for Roche.

The company is well positioned in oncology, one of the last great growth areas in the industry. Roche may not be the biggest drug company, but it is arguably one of the best.

The Week Ahead - July 23-29

July 23-24 – Institute of Medicine’s Roundtable on Evidence-Based Medicine workshop, “Common Ground: Leadership Commitments To Improve Value in Health Care" in Washington, D.C. The Roundtable seeks the development of a learning healthcare system that is designed to generate and apply the best evidence for the collaborative health care choices of each patient and provider, to drive the process of discovery as a natural outgrowth of patient care, and to ensure innovation, quality, safety, and value in health care.

July 24 – Congressional Global Health Caucus, and Advancing Women's Leadership and Advocacy for AIDS Action Partners is presenting, "Women Leaders Speak! Global Priorities for Action Against AIDS" in Washington, D.C.

July 24 –Food and Drug Administration (FDA) is holding a meeting of the Oncologic Drugs Advisory Committee discuss the following new drug applications (NDA): NDA 022-042, EVISTA (raloxifene hydrochloride) Tablets, Eli Lilly and Co., proposed indications for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of breast cancer; and NDA 021-801, proposed trade name ORPLATNA (satraplatin capsules), GPC Biotech Inc., proposed indication for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) that has failed prior chemotherapy.

July 26 – Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee is meeting. The committee will meet in open session to hear updates of research programs in: (1) The Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA and (2) the Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research, FDA.

Friday, July 20, 2007

Prescription Tampering

U.S. Representatives are rethinking prescription fraud. Representatives Charles A. Wilson (D-OH), Marion Berry (D-AR) and Mike Ross (D-AR) have proposed legislation that would water-down a provision already approved by Congress in May and that is scheduled to take effect in October. [No, not that Marion Barry, this is the other Marion Berry.]

The original legislation would deny Medicare reimbursement for prescriptions unless they included fraud protection and tamper-resistant notepads. Patients would have needed to find a willing physician to prescribe non-medically necessary products (not a tall bar to clear). The Wilson/Berry/Ross provision still requires tamper-proof prescription pads for narcotics, but only for narcotics.

The October start deadline of the original law would have been difficult to achieve and the three Democrats had strong lobbying by the chain pharmacies and the American Pharmacists Association. Many doctors are already using tamper-resistant technology.

If October is not enough time to implement the processes, delay the law from taking effect. However, turning your back on an avenue for prescription drug abuse is not acceptable conduct for Congressional representatives. [It really does make you wonder which Marion Berry/Marion Barry is behind this, doesn’t it?]

Encysive on the Market


In an announcement that surprises exactly no one, Encysive has put itself on the market. The company has retained the services of Morgan Stanley to investigate strategic options and shareholder value. Rumors have already started on possible suitors, including Biogen Idec, Roche and sanofi-aventis. At this point, it’s still a wide open field.

This comes on the heels of the company’s third approvable letter from the FDA and a request for additional clinical trials (see PAH: Big News in a Small Disease). Additionally, Gilead received approval for a competitive product – Letairis. Finally, in late June, Encysive axed its CEO and laid-off 70% of its staff (see Encysive Excises Executives).

Wednesday, July 18, 2007

A Truckload of Healthcare Bills

It’s official – New England is wicked mad. And crazy too. Yesterday, Maine’s Governor John Baldacci signed 18 healthcare reform bills. Together, the bills amount to…just about nothing. The Governor took the important step of establishing November as Lung Cancer Awareness Month and other similar pieces of groundbreaking legislation.

Among the more interesting bills was funding for an academic detailing program. Jerry Avorn has spent decades advocating for this, without any success, so Maine might as well give it a shot too.

Snuck in with the other 17 bills was a physician secrecy bill. So, Maine has officially gone the way of New Hampshire and Vermont by enacting physician secrecy legislation. The laws – which are nothing more than a big, upturned middle finger to the drug companies – will likely have no real impact. The secrecy law in New Hampshire has already been overturned on Constitutional grounds (see New Hampshire Data Ban Struck Down. It’s only a matter of time before the same goes in Vermont and Maine.

All of these bills in Maine are just a chance for some state reps to blow off some steam. It’s good play on the 5:00 news and at the local senior center. The good news is that it won’t have any real impact on how pharma operates in the State.

Monday, July 16, 2007

The Unmedicated Mind

Nancy Keates’ article in last week’s Wall Street Journal by the same title sent me down a little walk of memory lane.

Keates article on the joys of naturopathy, homeopathy, acupuncture and other age-old treatments for mental illness brought back discussions of my earliest days in the medical field. In the Freudian world context, we talked of depression as an inward manifestation of self-loathing or a response to a lack of sexual activity. The most common “naturopathic” remedy was masturbation. I’m with Joycelyn Elders – masturbation is great, unfortunately it’s not likely to offer any real benefits to the depressed patient.

Keates article raises good points. “Alternative therapies” or “complimentary medicine” can and should have its place in the medical field. The benefits of things like acupuncture in helping patients stop smoking and light boxes for depression/seasonal disorders are well documented. Like most Americans, I’ve also dabbled in the natural medicine route. I’ve tried herbal therapies for things like my stress headaches and the flu. Did they help? Not really, and it wasn’t worth the nasty case of diarrhea. But my chiropractor did wonders for stress tension headaches and muscle spasms.

The problem with Keates’ article is what I call “medicine by anecdote.” A patient (who may or may not really have depression) in Keates’ article visits a chiropractor and is suddenly cured of her depression...and presumably this will benefit all the other patients who read the article Rather than seeking medical help (from a psychiatrist or even a chiropractor), articles of this sort encourage patients to seek out alternative or complimentary therapies with no real oversight (the “self-diagnosing and self-treating patient”). For the hypochondriac patient in which even the most minor symptoms are blown out of proportion, there’s probably no real harm. For the seriously ill, it’s dangerous.

Reimbursement Based on Effectiveness

Pharma companies may be treading where doctors have been unwilling to go – meaningful pay-for-performance. Pharmaceutical companies are engaging in risk-sharing with payers, including governments and insurance companies.

According to Saturday’s New York Times, companies like Johnson & Johnson, GlaxoSmithKline, Biogen Idec and others are accepting reimbursement based on actual effectiveness of their drugs. This takes health outcomes one step further and provides compensation based on actual effectiveness of pharmaceutical products.

For an embattled pharmaceutical industry, this is a great way to demonstrate the value of its products!

Sunday, July 15, 2007

The Week Ahead – July 16-22

July 16 – Health Affairs is holding a briefing, "Financing and Improving Global Health Care" at the National Press Club, in Washington D.C. How can international health aid be improved? What role should the US government play in confronting global health challenges? What are Congress's priorities for the reauthorization of the President's Emergency Plan for AIDS Relief (PEPFAR), and how much should be invested in research to help stem the AIDS pandemic? How can we protect 150 million people globally from suffering financial catastrophe each year because of medical bills? Leading policymakers, international health researchers, analysts, and economists will explore these and other questions during a briefing on financing and improving global health care. Rep. Tom Lantos (D-CA), chairman of the House Foreign Affairs Committee and coauthor of the original PEPFAR legislation, will discuss the future of the program.

July 16 – The Alliance for Health Reform is holding a discussion on "Medicare Advantage: Whose Cost, Whose Benefit?" Participants in Karen Ignagni, president and CEO of America's Health Insurance Plans (AHIP); John Rother, policy and strategy director of AARP; Joseph Antos, Wilson Taylor scholar of the American Enterprise Institute; Jeanne Lambrew, associate professor at George Washington University; Diane Rowland, executive vice president of the Henry Kaiser Family Foundation; and Ed Howard, executive vice president of the Alliance for Health Reform.

July 16-18 – NCI, National Center on Minority Health and Health Disparities, and National Center for Research Resources is sponsoring “Cancer Health Disparities Summit 2007.” The annual Cancer Health Disparities Summit brings together some of the nation's top researchers in the field of cancer health disparities. NIH grantees, health professionals, and community advocates from across the country will gather to discuss their research, successful program strategies, challenges, and accomplishments.

July 17 – The Brookings Institution is holding a “Forum, "Who's Got the Cure? Four Options for Achieving Universal Coverage.” The Hamilton Project at Brookings hosts a forum on health care reform and releases four alternative policy proposals for achieving universal health care coverage for all Americans. Former Treasury Secretary and Hamilton Project Advisory Council member Robert E. Rubin delivers opening remarks.

July 17 – The National Committee to Preserve Social Security and Medicare (NCPSSM) and the Center for Medicare Advocacy, Inc. are having a briefing on "Medicare Advantage Overpayments: Undermining Traditional Medicare, Shortchanging Beneficiaries."


July 17 – Senate Health, Education, Labor and Pensions Committee and the Retirement and Aging Subcommittee is holding a hearing on "Federal Response to the Alzheimer's Epidemic." Will include Elias Zerhouni, director of the National Institutes of Health; Julie Gerberding, director of the Centers for Disease Control and Prevention; Andrew von Eschenbach, commissioner of the Food and Drug Administration; and Richard Hodes, director of the National Institute on Aging.

July 17 – The American Enterprise Institute for Public Policy Research is hosting a discussion titled, "I Pay, You Pay, Variable Co-Pay: The Next Generation of Health Insurance Design.” Participants include Peter Orszag of the Congressional Budget Office; Mark Fendrick of the University of Michigan; Mark Cullen of the Yale University School of Medicine; Mark Pauly of the University of Pennsylvania; Bill Thomas and Alex Brill of AEI.

July 19-21 – The Medical University of South Carolina is presenting “"The National Conference on Health Disparities: Past, Present and Future."

Head for the Hills


The heat wave here in the U.S. is a bit of a killer, so I took some unexpected time off last week and headed for the hills. The mountains aren’t much cooler, but at least it was bearable.

Pharm Aid will be back on its usual schedule this week.

Monday, July 9, 2007

The Week Ahead

July 10 – House Oversight and Government Reform Committee is holding a meeting "The Surgeon General's Vital Mission: Challenges for the Future."

July 10 – Centers for Medicare & Medicaid Services is holding “The National Medicare Education Program Partnership Alliance” meeting. Began as an educational effort as a result of the Balanced Budget Act of 1997, which expanded Medicares health plan options by creating the Medicare+Choice program.

July 10 – CMS is holding “Physicians, Nurses, and Allied Health Professionals Open Door Forum.” The Open Door Forum (ODF) addresses the concerns and issues of Medicare and Medicaid physicians, non-physician practitioners, nurses, and other allied health care specialists.

Friday, July 6, 2007

Behind the Scenes of the Provenge

The decision by Howard I. Scher of the venerable Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan to vote against approval of Dendreon’s cancer vaccine, Provenge, at a recent FDA Advisory Committee received some major attention in today’s Washington Post. The doctors are claiming they are fearful for their safety because of patient advocates.

Patient advocates have certainly launched an offensive against the decision to withhold approval. Depsite following the trial protocol that was agreed to with the FDA, the outcomes were uncertain. Provenge appears to have minimal adverse events, but the benefits are not entirely clear…at least in the short term. The drug has clearly worked for some. And the hope that it will work for others is leading patient advocates to push for approval. Standing in the way of new treatment for prostate cancer are Drs. Howard I Scher and Maha Hussain. Their reasons for voting against approval are far reaching and include lack of achieving certain endpoints, lack of clarity on other endpoints, and perhaps reasons that are less clear.

Much has been made in today’s Washington Post and in online message boards of the doctor’s relationships with competing companies. When I first started researching this, I figured it was going to be a whole lot of nothing. Many researchers have relationships with numerous firms. It’s not uncommon and I would have been surprised to learn that the doctors had no relationships.

True to form, according to government disclosures, Howard I. Scher either currently or has owned stock in Genta (which is developing the Genasense technology). He has acted as a consultant to Sanofi-Synthelabo (now sanofi-aventis; which has its own cancer vaccine program). And has accepted more than $2,000 from AstraZeneca and Aventis. At face value, this really isn’t news and seemed to be patient advocates getting worked up over nothing.

However, I then noticed that both Scher and Hussain are investigators in trials for Novacea’s Asentar, a potentially rival prostate cancer treatment. And less than a month after their vote against Provenge, Novacea inked a major deal with Schering-Plough to market the product. Had the FDA just approved a potentially rival product like Provenge, what would that have done to the value of the deal? Everyone can draw their own conclusions, but all I will say is that this is a case of remarkable timing.

The whole Provenge mess really shines a light on the clinical trial process for all of the cancer vaccines. The clinical trials tend to be quite long and involved. In the early days, it was not uncommon for the standard of care to be different by the end of the trial than it was at the beginning. Companies began engaging in Special Protocol Assessment Agreements with the FDA to stop the process of being held to one standard at the end of the trial than they were at the beginning. It is critical that the FDA needs to figure out how it will evaluate cancer vaccines and then stick to that standard.

Physician Takes Aim at First Amendment

Doctors and their allies are taking aim squarely at their patients. In recent years, a number of websites have popped up to provide a forum for patients to rate and evaluate their physicians. These sites include RateMDs.com, HealthGrades.com, DrScore.com, DoctorScoreCard.com, Healthcarereviews.com, and on and on and on. Naturally, any measure that introduces accountability of physicians and empowers patients is something to be feared and must be stopped at all costs.

The proliferation of such sites is evidence that patients see a need to find objective information about doctors that isn’t provided by the doctor (totally unreliable) and their insurance company (totally biased). Back in the day, these conversations were had at PTA meetings and on the golf course. But in this era of technology, it’s all online and out in the open.

The word is out in the physician community and Dr. Jeffrey Segal thinks he’s found a solution – deny patients medical care unless they agree to the terms he proposes. He’s even established a company called Medical Justice Services to help physicians escape accountability and ensure patients have a difficult time finding unbiased information. Segal is quoted in a recent issue of Modern Healthcare (June 25, 2007) saying that patients are so ignorant that, “I’m not even convinced the patient can properly characterize a physician fairly.” Yup, it’s the Physician-as-God complex again.

Dr. Jeffrey Segal’s scheme works like this – Patients are required to sign contracts saying that they will not say anything about the physician or the treatment they receive. In exchange for which, the doctor will actually treat the patient. There’s an interesting twist in the contract in which, if the patient signs, the doctor also agrees to abide by HIPAA regulations and not sell the patient’s personal medication information to marketers. (Segal “sells” this to patients by claiming he’s “giving” the patients additional privacy protection above the law.)

If a patient signs the contract and says anything about their care to anyone, the wealthy physician can go after the patient for damages. If the patient does not sign, the physician denies medical care. Simple as that.

What new scheme will doctors think of next?

Al Gore’s Son Busted for Rx Drugs


Al Gore III was arrested for his fourth time earlier this week. Next stop for Al Gore III, a cameo on A&E’s hit show INTERVENTION.

In addition to a small amount (less than one once) of marijuana, Gore had a whole stash of prescription medications, including Xanax, Valium, Vicodin and Adderall. Here’s my question – is Gore merely using or is he dealing?

Thursday, July 5, 2007

94 Die in Panama of Counterfeit Drugs


At least 94 people in Panama are dead due to counterfeit glycerin, and hundreds of more deaths are under investigation, according to the AP. The local Panama News puts the death toll over 100 and climbing fast. I first talked about fake diethylene glycol in my post Counterfeit Glycerin Floods Global Markets – Patients at Risk on May 7.

A Chinese firm sold the counterfeit glycerin (which was actually diethylene glycol) to Medicom SA, a Panamanian firm. With relative ease, the counterfeit glycerin was able to flood the global market and find its way into dozens of different countries.

Tuesday, July 3, 2007

Fact-Checking Sicko


A major challenge people will be facing over the next few weeks will be separating fact from spin in Michael Moore's "Sicko." On Sunday, the AP carried an exceptional overview of the facts surrounding the movie. I reprint the entire AP article below as it provides the factual context missing in Moore's movie.





By KEVIN FREKING and LINDA A. JOHNSON, Associated Press WritersSun Jul 1, 1:52 AM ET

In many respects, Michael Moore's new movie, "Sicko," is like a trial for those who oversee health care in the United States. The industry — doctors, drug makers, hospitals, insurers — is charged with greed and putting personal interests above patients'. Moore heard from thousands of people who had maddening and heartbreaking brushes with this system.

As chief prosecutor, Moore lets them do most of the talking and weaves their stories into the film with wit, compassion and humor.

But one aspect missing from the film is the defense. Do not expect to hear anyone speak well of the care they received in the U.S. On the other hand, patients and doctors from Canada, Britain, France and Cuba marvel at their health care.

Moore tells viewers there are about 50 million people in the U.S. without health insurance.
Just this past week, the Centers for Disease Control and Prevention estimated there are about 43.6 million uninsured people in the country. In March, the Census Bureau put the number at 44.8 million.

Moore noted that about 18,000 people die each year as a result of the lack of health insurance. That number comes for a January 2004 report from the Institute of Medicine. The report said the uninsured do not get the care they need and are more likely to die prematurely.

Taking on the pharmaceutical industry, Moore says it spent millions of dollars lobbying Congress for a Medicare prescription drug benefit.

"Of course it was really a bill to hand over $800 billion of our tax dollars to the drug and health insurance industry," he said.

Moore is citing the projected cost for the Medicare drug benefit's first 10 years.

Last year, however, Medicare officials told The Associated Press that the projected cost of the benefit through 2015 stood at about $729 billion, a substantial drop compared with original estimates.

Moore also noted the some of the elderly in the drug program could end up paying more for their prescriptions than they did before. That is true. But the vast majority do save because of the tens of billions of dollars in annual government subsidies to help cover the cost of their medicine. The Centers for Medicare and Medicaid Services says people save about $1,200 a year on average by participating in the program, called Medicare Part D.

At one point, Moore notes where the U.S. ranks in terms of health care around the world.

"The United States slipped to No. 37 in health care around the world, just slightly ahead of Slovenia," he said.

That ranking is based on a 2000 report from the World Health Organization that some health analysts viewed as misleading.

Moore does not say that one of the countries he highlighted, Cuba, is ranked 39th, below the U.S. Among the others, France is ranked No. 1, the United Kingdom ranked 18th and Canada ranked 30th. He does not give those rankings, either.

The report, based on 1997 data, measured not just the quality of care provided, but how well the countries prevented illness and how fairly the poor, minorities and other special populations are treated.

Moore's film includes security video showing a disoriented elderly woman in a hospital gown and slippers wandering in the gutter of a busy Los Angeles street. Kaiser Permanente Bellflower Medical Center near Los Angeles had discharged her and sent her off in a cab. Eventually, a staff member from the Union Rescue Mission in the city's crime-ridden Skid Row area comes out to help the woman.

The March 2006 incident was widely documented. This May, Kaiser Permanente, the country's biggest health maintenance organization, reached a settlement with Los Angeles prosecutors requiring Kaiser to make changes to end the dumping of homeless patients on streets.

Los Angeles authorities are investigating allegations that a dozen area hospitals have dumped more than 50 homeless patients downtown. On Wednesday, prosecutors filed civil complaints against two other hospitals and a transportation service accusing them of dumping homeless patients in Skid Row.

In the movie, Moore correctly states that the chief executives of health insurance companies make millions of dollars a year.

Among the insurers mentioned are Humana Inc., where chief executive Michael McCallister received about $5.9 million in salary and other compensation in 2006, and Aetna Inc., where chief executive Ronald Williams last year received salary and other compensation totaling about $30.9 million. Those figures were determined by an AP analysis of company filings with the Securities and Exchange Commission.

Huge executive salaries are the norm in all of corporate America. An AP analysis of 386 Fortune 500 companies' executive compensation reports showed that half the CEOs made more than $8.3 million last year.

In the film, an insurance company call center employee says her company has a list of pre-existing conditions that would "wrap around this house." The conditions, including diabetes, heart disease and cancer, make applicants ineligible for coverage. Numerous disorders then scrolls up a black screen in yellow letters — think of the "Star Wars" movie introductions.

Karen Ignagni, president and chief executive of the trade group America's Health Insurance Plans, said Moore does not identify the plan involved but that it is not a typical one. She said about 17 million people in the U.S. are insured under individual plans and an additional 200 million under group plans.

"If that list were true, none of those people would be getting health insurance," Ignagni said.

Ignagni said decisions about which treatments are covered by a plan are made by the sponsor, such as an employer, not by the insurer.

Moore also takes on the notion that universal health coverage leads to longer waits in hospital emergency rooms and to see doctors.

He visited a crowded emergency room in Canada and asked patients how long they had to wait. One said 20 minutes; a second said 45 minutes. "I got help right away," a third said.

Yet a recent report from the Commonwealth Fund indicates that wait times in the U.S. are clearly shorter than they are in Canada.

In all areas measured, the U.S. fared better than Canada. For example, 24 percent of Canadians waited four hours or longer to be seen in the emergency room versus 12 percent in the U.S. The difference was more acute when it came time to see a specialist. Fifty-seven percent of Canadians waited four weeks or longer to see a specialist versus 23 percent in the U.S.

The Commonwealth Fund also monitored wait times in Britain, which has universal health care. The wait times for emergency room care were comparable to those in the U.S.. There was a big difference when it came time to see a specialist — 60 percent in Britain waited four weeks or longer.

The film concludes with a trip to Cuba where Moore seeks care for a group of workers who have experienced health problems after responding to 2001 terrorist attacks. They are greeted with open arms at a hospital in Havana and given what appears to be top-notch care that they could not get in the U.S. The question left for viewers to ponder is whether Cubans are given such red carpet treatment, too.
[Linda A. Johnson reported from Trenton, N.J.]

Roche Gets Approval for New Tamiflu Dosing


Roche received FDA approval for low-dose Tamiflu treatment in children age one year and older. The dosing will be 30 and 45 milligrams. According to the company, the product will have a five year shelf life, far longer than the adult dosing.

The extended shelf life could provide significant benefit to the company for pandemic flu response and government stockpiling.

CMS Proposes Cuts in Physician Fees

CMS is proposing a nearly 10 percent cut in doctors’ fees for 2008 under Medicare. The proposed cut is more significant than in any the previous five years due to Congressional intervention on behalf of physicians.

Bloomberg reports that if this fee schedule were adopted, Medicare alone with pay out almost $59 billion to doctors in 2008. If Congress again intervenes, that number could be significantly higher.

The chances of Congress stepping in and helping out physicians is looking pretty good.

Monday, July 2, 2007

Sanofi-Aventis Withdraws Zimulti Application


sanofi-aventis announced on Friday that it would withdraw its NDA for Zimulti/Acomplia (rimonabant). This announcement comes just about two weeks after an advisory panel did not back the drug for approval.

The company said it will re-submit the drug for approval in the future.

West Virginia: Drug Companies Liable for Docs Prescribing

The West Virginia Supreme Court of Appeals has rule that pharmaceutical companies are ultimately and partially liable for physician’s prescribing (see original story). The Court stated that J&J Janssen had a responsibility to directly warn the patient of risks.

While the case will probably be appealed to the Supreme Court, it is likely to have far-reaching effects on how drug companies view physicians. While physicians may complain that the “big brother drug companies” are watching them through sales reps now, just imagine what happens when drug companies are held fully responsible for their decisions. This is a case to follow…

Riding Sicko’s Coattails

Individuals opposed to the pharmaceutical industry are desperately trying to associate themselves with Michael Moore’s film Sicko in the hopes of scoring some free press. So, I’ll be happy to oblige—

A woman named Kathleen Slattery-Moschkau (who bears a striking resemblance to Marilyn Manson) has put out her second press release in two days trying to ride Moore’s coattails. The first press release was an apology to Moore for her statement in USA Today in which she said, “I’m not Michael Moore.” Let’s take a closer look (and throw in Manson for comparison):



Nope, she’s not Michael Moore. I guess it was tough for some people to tell the difference.

Slattery-Moschkau’s statement was made in an apparent Dr. Jerry Avorn moment, in which she made assumptions about Moore’s movie without ever having seen it (Avorn did the same thing with J&J’s InnerState).

The second press release is a blatant media plea to include her in any story about Michael Moore’s new film Sicko (of course, I'm happy to oblige). To quote from her press release, “As you report about ‘Sicko’ this week, you may want to talk with Slattery-Moschkau.” She is currently promoting her new straight-to-the-Internet video called PERX. I think I found PERX here on YouTube (yes, that appears to be a bong). Kathleen Slattery-Moschkau can be reached at (209) 736-6769 or visit the tour schedule.

July Medical Meetings

I just realized I never posted the June medical meetings. Sorry. We’re jumping right into the July meetings (a pretty quiet month)—

July 20-22 – Annual House of Delegates Meeting for the American Association of Colleges of Osteopathic Medicine (AACOM) at the Fairmont in Chicago.

July 28-31 – 13th World Congress on Heart Disease sponsored by the International Academy of Cardiology at the Hyatt Regency in Vancouver, British Columbia.