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In an era of personalized medicine we can and must do better than just shoving people into taking the cheapest drug and then seeing if people slip in convulsions. Ultimately many more drugs are going to to go generic so treatment selection will still be an issue and so will the attendant costs.
NOT WHAT THE DOCTOR ORDERED
The Detroit Free Press
By Patricia Anstett 6/5/2009 5:30 AM
Busy with other chores, Kathryn Pauley asked her 16-year-old to pick up younger daughter Cheyenne 's seizure medicine at a pharmacy.To her surprise, Pauley found a generic drug, not Lamictal, a brand-name drug that had effectively controlled most of Cheyenne 's seizures. In the next week, Cheyenne , 11, had 21 seizures -- many more than usual.
The switch occurred even though Cheyenne 's doctor had written "dispense as written," or DAW, on the prescription. Cheyenne 's Medicaid policy refused to fill the prescription until her doctor challenged it, said Pauley of Belleville.
A fierce legislative campaign is playing out in Michigan and other states over generic substitution and therapeutic switching, a practice that allows health insurers to fill a prescription with drugs similar to brand-name drugs.
Usually, a doctor can stop a switch by writing DAW on a prescription. But problems still can occur and appeals are time-consuming.
James McCurtis, a spokesman for Michigan 's Medicaid program, said the state prefers to use money-saving generics when possible. Doctors can apply through a process called prior authorization to get a brand-name drug for a patient, but McCurtis acknowledged that process may be time-consuming.
The Michigan Osteopathic Association and the Michigan Association of Family Physicians want changes to ensure consumers are alerted about prescription changes. Health plans and the Michigan Pharmacists Association see any new laws as unnecessary. Either way, there are important issues for consumers to understand.
Mich. fight over generics heats up
The push to use generic drugs has brought big savings to U.S. health care -- $734 billion over the last decade.
But as much as they support ways to hold down health costs, the 7,000-member Michigan Osteopathic Association and the 3,000-member Michigan Association of Family Physicians have some worries. They're concerned that the preference by many health plans toward generics and nearly-equivalent drugs called therapeutic substitutes leave too many patients and their doctors out of the decision-making about which drug they can prescribe or use.
They want state laws to ban payments and other incentives that health plans and pharmacy benefit management companies use to encourage doctors to prescribe generics and so-called therapeutic equivalents -- drugs like but not identical to brand-name drugs.
Another bill would require a patient's consent before a pharmacy could switch a brand-name epilepsy drug to another drug.
Popularity of generics
The issue is significant as more health plans promote generic drugs and Americans look for savings, particularly as they lose insurance or face higher out-of-pocket co-pays. Generic use has risen from 61% in 2006 to nearly 70% today, according to the Generic Pharmaceuticals Association, in a May report.
"Physicians feel they are being handcuffed more and more," said Dr. Craig Magnatta, president of the Michigan Osteopathic Association.
The osteopathic association has produced a printable, wallet-sized card on its Web site to help patients learn about the issue at
www.michigando.com
Every day, Magnatta, a family practice physician with offices in Rochester Hills and Oxford , and one of his assistants plow through a pile of paperwork with insurance company denials or questions about drugs he prescribed.
Many plans won't pay for many brand-name drugs, at least not initially. Health plans particularly make it difficult to prescribe certain drugs, such as epilepsy medicines, antidepressants, blood thinners, proton pump inhibitors, psychiatric, thyroid, pain and antirejection medicines, he said.
Two bills that address generic issues await action later this year by the Senate Health Policy Committee, which postponed a hearing in May. Committee chair, Sen. Thomas George, R-Kalamazoo, said the bills may be reworked.
Unnecessary action?
Michigan 's health plans and the Michigan Pharmacists Association consider the legislation unnecessary.
Dr. Tom Simmer, senior vice president and chief medical officer of Blue Cross Blue Shield of Michigan, said generics have produced sizeable savings, including as much as $1,000 a year for consumers, at a time when many have no insurance or higher drug co-pays.
Nationwide, generics have saved consumers $734 billion over the last 10 years, according to a report issued in May by the Generic Pharmaceutical Association.
"We're saying, before you jump to the $120 a month antacid, try less costly ones," Simmer said.
As more drugs go generic, brand-name drug manufacturers are spending millions of dollars on direct-to-consumer advertising campaigns that inflate health costs by encouraging consumers to ask their doctors to prescribe brand-name drugs, Simmer said.
Antonio Petitta, vice president of pharmacy care management for the Health Alliance Plan, said he thinks the legislation will add red tape.
"It adds a layer of difficulty to prescribing," she said.
Trouble with epilepsy
Arlene Gorelick, executive director of the Michigan Epilepsy Foundation, which favors the bills, said her group and its national foundation are tracking increased incidence of seizures in people who have had to change to generics and therapeutic equivalents.
"Antiepileptic drugs are very precise and establish a delicate balance for each individual with epilepsy," Gorelick added. "No two medications are alike. Even slight changes can cause ... seizures."
Others point out that groups like the Epilepsy Foundation receive funding from brand-name drugs, a fact Gorelick acknowledges but said did not influence the organization's position on the issue.
"The Epilepsy Foundation of Michigan does receive unrestricted educational grants from pharmaceutical companies and device makers, as well as from hospitals and insurance companies," Gorelick said. "These dollars represent a small percentage of our operating budget."
Bringing down costs
Dr. Rick Smith, president of the Michigan State Medical Society, an 11,000-member physician's organization affiliated with the American Medical Association, said his organization has not taken a position on the bills.
Smith said electronic or E-prescribing systems make it easier to track which drugs health plans pay for or prefer to use first and cut out some of the red tape. He was an early user of generics and electronic medical systems in the Henry Ford Health System, where he's an obstetrician/gynecologist.
Generics are "one of the best ways to bring excessive costs down." But he agrees some drugs such as seizure medicines may not be easily substituted, as the therapeutic range of those and some other drugs is narrower, he said.
Additional Facts Drug legislation
Two bills in the Legislature, supported by two state physician organizations and some patient support groups, address generic substitution and therapeutic switching.
# SB 318 prohibits health plans from making payments or giving other incentives to doctors and other health professional to prescribe certain drugs. It also would require Michigan 's attorney general to report quarterly on any payments or incentives that might be viewed as inducements to prescribe a certain drug.
# HB 4408 bans substitution of brand name epilepsy drugs without the consent of the doctor, patient or legal guardian.
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.