Latest Drugwonks' Blog
Along with the critique by Dranove and Millenson here.
Excellent omnibus article on healthcare in the Age of Obama in this month’s edition of PharmaVoice. It’s titled, “Obamaceuticals” and can be found here.
I went to the doctor today and he says to me, "What do you do?"
I answer, "Healthcare policy."
He responds, "So you don't need to do any heavy lifting."
I wince.
And here's the punchline -- my hernia will be operated on by Dr. Lo.
Pfizer tries new uses for failed drugs
When scientists at Pfizer's Sandwich research facility in
However, when early clinical trials were conducted, the results suggested the drug wasn't sufficiently effective for its intended use. But it did work amazingly well for something else. It caused penile erections. So Pfizer decided to market the compound as Viagra and, in 1998, the drug made history as the first oral treatment approved to treat erectile dysfunction in the
The tremendous success of this pharmaceutical recycling effort is far from lost on Pfizer, the world's largest drug maker. About two years ago, it formed a research group to find alternative uses for compounds that don't work as intended. The 50 scientists in the group also try to find other opportunities for drugs in their early development stage.
The Indications Discovery Unit has a new home in the recently opened $200 million research building on the Pfizer Global Research and Development campus in
Donald Frail, chief scientific officer of the Indications Discovery Unit and director of Pfizer's
Most drugs must go through three phases of human testing. The first round is to make sure the compounds are safe. The second and third test whether the drugs are effective for their intended use. Frail said more than 75 percent of drugs in development never make it past Phase II of testing.
"It's a daunting job," Frail said about being a drug researcher. "It's a minority of scientists that see their drugs get to market."
Frail said Pfizer now focuses on six principal areas: oncology, inflammation, neuroscience, diabetes, cardiovascular and pain. Scientists in the Indications Discovery Unit look for other applications both within and outside those areas.
"The hunt is pretty fascinating," he said. "We let the compounds lead us to the patient. Our playing field is preset by the molecules."
An example of a drug being examined for other uses is Pfizer's Sutent, which is on the market for use against kidney and stomach cancer.
Pfizer has been testing it for other uses as well, and in March the company said Sutent showed "significant benefit" in patients with a form of pancreatic tumor.
But the research on the drug doesn't stop there.
"We're looking at it now for a different, totally nononcology application," Frail said.
Although most drugs never get regulatory approval, the possibility of finding a successful treatment or cure continues to drive researchers in their quest, Frail said.
"It's easy to be motivated when there are patients in need out there," he said.
Lots of gossip about the FDA supporting a codicil in pending tobacco legislation that would legalize drug importation. That's bad.
And remember, there's no such thing as drug "reimportation." That's putting lipstick on a pig. This isn't about making available to Americans the "same" drugs being sold to our neighbors to the north. This is about drugs from a multitude of nations (most notably those of the European Union). That means a drug that is said to come "from Great Britain" could just as easily originate from places such as Greece, Portugal, Latvia, or Malta. And basic economics dictates that goods from lower cost markets flow into higher cost ones. (In fact, more than 20% of all prescription medicines sold in the UK are "parallel imported" from lower cost nations within the EU.) These drugs, arbitraged through Canadian internet pharmacies and then resold to Americans may be dubbed "reimported" but that's just plain misleading -- because these off-the-back-of-the-truck medicines are not even legal for sale in Canada. So much for "the same drugs" as you can buy at a pharmacy in Toronto.
How can an FDA that wants to more robustly promote drug safety (and appropriately so) also support the importation of foreign drugs into the United States? It's bad enough when some of our elected officials choose to put rhetoric and politics in front of the public health -- it's something else entirely when such an attitude is adopted by the agency responsible for pharmacovigilance.
The career staff at FDA has consistently been against drug importation, so wither the switcheroo? Politics has no place in FDA decision making. And the last time I looked, the same career staff are in place. Draw your own conclusions.
In the spirit of transparency: what is the FDA's position on drug importation?
Last week we wrote about “Tamiflurry.”
A brief recap:
On May 4-5 the Harvard Business School Health Alumni Association along with the Young Presidents Organization/World Presidents' Organization (YPO/WPO) sponsored a conference in Washington, DC, "Health Reform at the Intersection of Government and Markets.” After two days of robust debate and discussion over a wide range of issues, the event ended with a troubling episode.
So troubling, in fact, that one physician in attendance along with another independent businessman felt obligated to write to Randy Cohen, who pens “The Ethicist” column at the New York Times, with the following query:
“We were attending a conference on health reform which had included an impromptu presentation on the swine flu pandemic. As the conference was closing, a physician was introduced and he said that as a “treat” for all his fellow attendees he would write prescriptions for TAMIFLU and that if he ran out of scripts, he would send one to anyone who emailed him a request. A large line immediately formed of people eager to avoid the risk of shortages or rationing. When confronted with our question as to the ethics and legality of his offer, he explained that he was a physician and had worked with the CDC and was confident he was acting in a morally and professionally correct manner – was he? For that matter, were the conference organizers in ethically troubling territory?”
The full post can be found here.
Our post was directed at Dan Brock, the Director of the Harvard University Program in Ethics and Health.
Herewith (and with permission) is Dr. Brock’s response:
“If your description of what transpired is accurate, then the action of offering an Rx for Tamiflu to all the attendees at this meeting was in my view clearly unethical, and essentially for the reasons you and Randy Cohen cite. Physicians should not be writing prescriptions for persons who are not their patients, nor should they be encouraging others to stockpile a potentially scarce drug. Why the organizers of this event permitted it I have no idea, nor do I know who they were.
You ask what can I do about this. The answer is probably not much, and that is not because I do not believe that what you describe as transpiring was not wrong. But neither of the two ethics programs at Harvard that I direct put them or me in the role of "ethics police" for everything that goes on connected with Harvard Medical School. The obvious parties with whom a complaint should initially be lodged are the organizers of the event who apparently permitted this to go on at the meeting.
If the physician offering the prescriptions was a member of the Harvard Medical School faculty then a complaint could also be lodged with the medical school. HMS has procedures for responding to allegations of faculty misconduct, but neither I nor my programs are involved in that process. I agree that an investigation of the matter is appropriate and one or both of these parties should be in a position to do so.”
Senator Grassley – how about an investigation?
Advisories led to 'unintended consequences,' researchers say
By Karen Pallarito
HealthDay Reporter
MONDAY, June 1 (HealthDay News) -- Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.
Read more herePeter and I, among others, were attacked for pointing out that hijacking of science surrounding the risks of antidepressants would lead to public health problems including an increase in suicide. In particular Shannon Brownlee and Jeanne Lenzer unleashed an ad hominem attack on both of us and Dr. Fred Goodwin that resulted in a witch hunt on Goodwin's reputation. Meanwhile the pseudo-scientific biases of Brownlee and Lenzer about the use of SSRIs in particular -- Brownlee claims that biochemically, "the drugs might trigger suicide and bipolar disorder" -- and asserts that there is no biological link between serotonin and depression (Scientology claptrap) or that doctors do not know which patients will respond to which meds (see the STAR-D trial for that) were used to fuel an attack not on the merits of the position but on funding sources.
Well, facts are stubborn things, particularly in biology where observation is...well, as Groucho Marx used to say, "who do you believe? Me or your eyes?" Scaremongering by Brownlee and Lenzer, combined with the witchhunt against shrinks who received pharma money allows those who "know" despite the data that SSRIs are a holocaust in waiting to dominate both the media and the mainstream medical journals who feed on each other.
And meanwhile the connective tissue between patient and doctor is shredded by fear. The public health suffers. People get sicker. They kill themselves.
Perhaps the relationship between industry and academia needs or needed a shakeup to focus more on risks and benefits. Industry deserves blame for not staying ahead of the curve on many of these issues and responding in a more timely fashion to potential problems. But the Brownlee and Lenzer school have an ideological approach to medicine: industry corrupts all it touches and it buries its pollution (the risks of its products) as a matter of policy. Much like the anti-vaccine groupies, in the face of mounting evidence they are wrong they find new excuses to remain unconvinced and unpersuaded.
We have seen the damage of their approach. They are partly responsible for promoting the decline in treatment and are responsible for the consequences.
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.
