Thursday, August 28, 2008
It is worth stating that like nearly all other cancer vaccine trials, the patients enrolled in the trial are the sickest of the sickest…those with metastatic disease that have failed other therapies.
Cancer vaccines been plagued by problems. Last year, the FDA torpedoed the hopes of many men with prostate cancer by failing to approve Dendreon’s Provenge (against the recommendation of nearly everyone, including its own advisory committee).
What’s with the trial lawyers? They are getting some serious ink over at Pharmalot. Pharmalot’s got a new posting up every couple days for the trial lawyers. Here’s his list for the month of August:
- Worried About Preemption? There’s a Petition (8/26/08)
- FDA Rule Shields Pharma From Lawsuits? (8/22/08)
- What Preemption? Device Lawsuit Can Proceed (8/18/2008)
- The Right to Sue: A Case Against Preemption (8/15/2008)
- Levine Files Preemption Brief With Supreme Court (8/8/2008)
- Biogen Loses Preemption Argument in Tysabri Case (8/7/2008)
And those are just the preemption stories. That doesn’t even count all the general lawsuit stories like:
- US Counties Can Sue Pharma Over Medicaid Pricing (8/28/08)
- Court Excludes Plaintiffs’ Expert In Accutane Trial (8/27/08)
- Sue Me: Pfizer Consolidates Some Legal Work (8/20/08)
- New Rule Forces Pharma To Disclose Lawsuit Costs (8/8/08)
Looks like the trial lawyers have a brilliant PR team!
Thursday, August 21, 2008
The primary reason for this is parental ignorance to vaccinations. Many parents continue to listen to ignorant pseudo-advocacy groups like Autism Speaks, which adopt positions that have been consistently refuted by science. But they have raised a lot of money by selling fear to parents.
Meanwhile, the children suffer.
And they just might be right. Then again, when relying on population-level analysis like this, there’s almost no therapy will prove to be cost effective on a population level.
But the individual level is a whole different story. Do we deny the therapy to thousands of women who will develop cervical cancer this year? Are we willing to accept the deaths of thousands of women because it is not “cost effective?"
Relying on population-level cost analysis ignores the very real patients who suffer from these diseases.
Reference: Wall Street Journal
Monday, August 18, 2008
Tara Parker-Pope’s recent article on prostate cancer in the New York Times just about sent me over the edge. Parker-Pope reports on the feeling that men are over-screened for prostate cancer. This is nothing new and has been circulating in the medical community for almost a decade. However, Parker-Pope seems to go one-step further and imply that men shouldn’t be screened for prostate cancer at all.
Conventional wisdom is that if cancer is detected through elevated PSA levels, doctors and patients feel compelled to treat the cancer, even if it does not progress. “Watchful waiting” does have its place in prostate cancer treatment. But not screening men at all for prostate cancer is, at best, irresponsible journalism and is, at worse, negligent.
Of course, what Tara Parker-Pope doesn’t tell readers is the motivation behind the article. The rationing of care, particularly for men’s prostate cancer, has been an agenda item for America’s Health Insurance Plans (AHIP). AHIP, in an effort to boost profits for its members corporations, has been selecting disease categories to target for restricting care. If the standard of care becomes to not test or treat for prostate cancer, these corporations could save loads of money. Who cares if an extra 30,000 to 50,000 men die?
The goals of society (i.e., rationing care and saving money) are not consistent with the goals of the individual (i.e., prolonging one’s life).
Sunday, August 17, 2008
It is worth noting the product has been approved and available for several decades overseas. The FDA trials process has been financially prohibitive and no company has been willing to invest…until now. This is a problem with all chronic orphan drug catagories.
“Until today, physicians and patients had no FDA-approved treatments for Huntington’s disease,” said Fred Marshall, M.D., chief of the geriatric neurology unit at the University of Rochester. “Within a few months, for the first time, physicians will be able to offer these critically-ill patients a safe and effective medication to treat their chorea.”
Related: Prestwick Pharmaceuticals Press Release
Wednesday, August 13, 2008
CSL and its U.S. unit CSL Behring have been hampered in recent years by management and strategy issues, and a challenging reimbursement environment.
Although, someone at CSL is asleep at the wheel on this one. It’s been nearly 24-hours since the announcement and the press release still isn’t posted on the CSL website (but it is on the Talecris website).
Tuesday, August 12, 2008
Niche industry player Surveillance Data Inc. (SDI) has purchased data mining firm Verispan. The acquisition will give SDI a much broader footprint for providing longitudinal prescription tracking. See the press release.
Not to be outdone, immediately after the Verispan announcement, IMS Health acquired the Russian market research firm RMBC. The acquisition plays to IMS’s bid to be the only global provider of data to the pharmaceutical industry. See the press release.
This is just the beginning of another round of consolidation in the industry.
Sunday, August 3, 2008
So how independent and unbiased are these so called experts? I Googled Andriane Fugh-Berman and found an article she had co-authored in the pseudo-journal PLoS. In her own words from the Conflicts of Interest section of her article: “Adriane Fugh-Berman has accepted payment as an expert witness on the plaintiff’s side in litigation regarding menopausal hormone therapy.”
The individuals on this list like Adriane Fugh-Berman, who add their names to this list while shilling for trial lawyers, are the same individuals who criticize doctors for purported conflicts of interest. Ironic? That someone could criticize a doctor for accepting a $5 subway sandwich while accepting thousands of dollars for providing expert testimony for trial lawyers is a bit hypocritical.
And of course, there’s Dr. Sidney Wolfe. Sid is much smarter than Adriane Fugh-Berman. He doesn’t accept the checks from the trial lawyer’s directly. Instead, the trial lawyers cut the checks to Public Citizen, which then pays his salary. [Note: Public Citizen currently does not qualify the organizations or individuals that provide it funding…if it’s green, they’ll take it] The funding of Public Citizen by trial lawyers is no different than what pharma does in funding “advocacy groups” via “unrestricted grants.” The trial lawyers keep an arms length and a “reputable” group like Public Citizens does what it’s told.
It wouldn’t surprise me if most of the names on the list shill for plaintiff’s attorneys or have as many conflicts of interest as the doctors they criticize.
The list is quite simply a list of individuals who do not have ties to pharma, but have many other undisclosed conflicts of interest. These individuals are hardly “independent” or “unbiased.” If someone wants to be an independent expert, then I absolutely applaud them for it. But don’t get all righteous for being anti-pharma or pharma free, when you (or your employer acting on your behalf) accept money for providing biased expert testimony. If you’re going to claim to be independent, then be truly independent.
It is worth stating that the list was created by discredited freelance journalist Jeanne Lenzer. Lenzer is a hired gun journalist available for hire to the highest bidder. Lenzer also maintains her own significant relationships with trail lawyers, which was chronicled in a New York Times article. The result was that one of Jeanne Lenzer’s employers, the once-reputable British Medical Journal, has had to apologize to pharmaceutical companies for her lapses in credibility and integrity. This alone should make the entire list of “independent experts” suspect.
I wouldn’t have ANY objections if the two pseudo-journalists who created this list (Jeanne Lenzer and her partner Brownlee) said only that this is a list of pharma-free experts. However, when they begin to introduce the word “independent,” I take exception. This is nothing less than an intentional mis-representation of these individuals.
All of this controversy came about because a pro-pharma expert, Peter Pitts, was not identified as such in a story on NPR. I wouldn’t consider Peter Pitts independent. And I wouldn’t call Jeanne Lenzer or anyone on this list independent either. If the real issue behind this is UNDISCLOSED conflicts of interest in the industry, then the anti-pharma foes of Lenzer, et. al. are just as guilty as Peter Pitts and the pro-pharma advocates. Pitts didn’t disclose on NPR, and Lenzer and the trial lawyer shills aren’t adequately disclosing either.