Latest Drugwonks' Blog
FDA Assistant Commissioner for Policy David Horowitz to become a deputy general counsel at the Department of Health and Human Service's Office of General Counsel.
He’ll be missed.
Another opportunity for Commissioner Peggy to remake the agency in her own image.
(And that's a good thing.)
“If you end up seeing patients that cost you money to see, and you have no other ability to make up for that ... then you have to decide if you’re going to continue to see more Medicaid patients,” said Tom Huber, MD, president-elect of the SDSMA in a March 2009 interview for KELO-TV. “If taking care of more people under
the Medicaid program means my business no longer survives, then I’m doing a disservice to all the other patients, and that’s the dilemma that physicians are facing.
You can read all about how shoving people into Medicaid could very well be the most cynical element of health care reform...
http://www.sdsma.org/documents/MedicaidSummerStudy.final.pdf
London, England (CNN) -- The entire genetic codes of two common types of cancer have been cracked, according to scientists, who say the breakthrough could unlock a new era in the treatment of deadly diseases.
Scientists at the UK-based Wellcome Trust Sanger Institute catalogued the genetic maps of skin and lung cancer and have pinpointed the specific mutations within DNA that can lead to dangerous tumors.
Researchers predict these maps will offer patients a personalized treatment option that ranges from earlier detection to the types of medication used to treat cancer.
The genetic maps will also allow cancer researchers to study cells with defective DNA and produce more powerful drugs to fight the errors, according to the the study's scientists.
"The knowledge we extract over the next few years will have major implications for treatment," Peter Campbell from the Wellcome Trust Sanger Institute said.
"By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments."
Scientists found that the DNA code for skin cancer contained nearly 30,000 errors and lung cancer DNA contained more than 23,000.
"These are the two main cancers in the developed world for which we know the primary exposure," Mike Stratton, from the Cancer Genome Project said.
"For lung cancer, it is cigarette smoke and for malignant melanoma it is exposure to sunlight.
"With these genome sequences, we have been able to explore deep into the past of each tumor, uncovering with remarkable clarity the imprints of these environmental mutagens on DNA, which occurred years before the tumor became apparent."
The study suggests that an error occurs for every 15 cigarettes that are smoked.
Scientists as part of the International Cancer Genome Consortium in other countries around the world are completing similar studies -- the UK is looking at breast cancer, the U.S. at brain, ovary and pancreatic cancer, and Japan at the liver.
Cancer is a leading cause of death worldwide and claims more than seven million lives each year according to the World Health Organization.
Michael Hiltzik writes in today’s Los Angeles Times:
“The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar.”
Well, at least we know where he’s coming from.
Hiltzik continues:
“Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?”
He refers to the Eshoo Amendment. He has a lot of problems with it – most notably the fact that it gives innovator products a dozen years of exclusivity. While it’s hard to take anyone who refers to follow-on biologics as “generics” seriously, a few points on why Mr. Hiltzik is completely wrong about the Eshoo language.
First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.
Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.
Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.
Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.
Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.
The complete Hiltzik column can be found here:
http://www.latimes.com/business/la-fi-hiltzik17-2009dec17,0,1929214.column
Senator Dorgan’s amendment on drug importation goes down with a vote of 51-48 in favor. (60 votes were needed to prevail under a special rule.)
Senator Lautenberg’s amendment (importation with Secretarial certification) also went down (56-43). According to the AP, “His proposal permits drug imports but adds a requirement that the U.S. government certify that the imports will be safe — a guarantee that Democrats and Republicans agree would be impossible to make.”
Sweet sanity.
Can we debate healthcare reform now?
Goldberg NewsNews Goldberg News, latest news about Goldberg News. |
VIDEO: WHO IS SPYING ON YOUR PRESCRIPTIONS?
Dec. 15: Pharmaceutical companies are increasingly peeking at doctor's prescription pads, raising many concerns. Dr. Nancy Snyderman talks with consumer health advocate Marcia Hams and Robert Goldberg, a pharmaceutical industry advocate. (Other)12/15/2009 23:20, msnbc
I didn't get a chance to be in this segment...I was in MSNBC's Green Room waiting to be led into the studio and saw the segment running. A producer (?) rushed in and told me to run into another studio where I was miked for the segment. Dr. Snyderman cut to commercial with a teaser about how kids who have a low sexual IQ are endangering themselves... (I was wondering if I had to shift gears and weigh in...) In any event, another MSNBC person came and told me I missed the segment, thanks but no thanks..
Anyways, what I would have said if had the chance.
First, as Peter noted previously, patient level data should not be used to market directly to patients.. That said, why is Ms. Hams organization proudly linked to a website from an insurance company that used patient prescribing data to bribe doctors to switch patients to generic drugs without telling them...
http://www.crainsdetroit.com/article/20090301/SUB01/902269981
Moreover, data mining and contacting patients is critical to promoting compliance and personalized medicine. Lack of compliance with prescription regimens is a source of increased illness, mortality and medical costs. It is a serious public health problem The generic uber alles approach pushed by The Prescription Project likely adds to the problem since studies show that tiered formularies and generic mandates tied to higher co-pays with other drugs are associated with increased illness.
http://www.managedcaremag.com/archives/0408/0408.drugtier.html
But even allowing drug companies to use data that patients and doctors voluntarily give is grounds for legal and political attacks. No surprise. Ms. Hams organization is lawsuit driven. It's Prescription Access Litigation Project generates revenue by suing drug companies and has partnered with tort law firms whose senior partners are now in the slammer for sleazy and illegal practices. Talk about putting profit ahead of patient wellbeing..
http://www.prescriptionaccess.org/press/pressreleases?id=0010
money.cnn.com/magazines/fortune/fortune_archive/2006/11/13/8393127/index.htm
In the last couple days Senator’s Dorgan drug importation amendment has proven a major stumbling block to passing a health care bill.
Whether or not Senator Dorgan is amenable to compromise remains to be seen. This puts President Obama in an incredibly difficult spot. On one hand, the more liberal members of his party are absolutely determined to squeeze more out of those evil pharmaceutical companies. But PhRMA struck a deal early on in this process with the Obama administration and has heavily assisted in promoting the president’s health care agenda.
Will President Obama risk creating another obstacle to passing a bill by challenging Dorgan, or does he throw PhRMA under the bus?
As for Dorgan, if he is truly interested in cost control, then why not focus his efforts on the genuine waste in the system (particularly in Medicare and Medicaid) instead of attacking an innovative industry?
Could it be his only reason for pushing this perpetually nonsensical proposal is that the pharmaceutical industry makes for a politically convenient target that distracts from the really asinine aspects of the Senate bill?
Senator Dorgan needs to ask himself three simple questions:
1. Do prescriptions drugs save the health care system money in the long-term by rendering surgeries and lengthy hospital stays unnecessary?
2. How would Canada respond to US legislation allowing for importation of drugs?
3. Is importing drugs from Canada safe?
On the issue of safety, The Hill reports on FDA Commissioner Margaret Hamburg’s letter to Senator Sam Brownback:
The Dorgan amendment “as currently written, the resulting structure would be logistically challenging to implement and resource intensive. In addition, there are significant safety concerns,” Hamburg wrote in a letter to Sen. Sam Brownback (R-Kan.), related to preventing counterfeit or mislabeled medicines from being sold in U.S. pharmacies.
“We commend the sponsors for their efforts to include numerous protective measures in the bill that address the inherent risks of importing foreign products and other safety concerns relating to the distribution system for drugs within the U.S.,” Hamburg wrote, while emphasizing the legislation does not achieve those objectives.
What was Dorgan's response to the FDA's statement?
He called it "completely bogus."
Wow, now there’s a measured response.
If Dorgan loses re-election next year, maybe he can look into a future position as FDA Commissioner. He apparently has the credentials for the job.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
