Latest Drugwonks' Blog
Dan Troy is right. The more FDA’s critics attack the agency, the more conservative some of the career staff becomes. This is partially defensive (think “turtle retreating inside the shell”) — but it’s worse. It’s the FDA sliding down the slippery slope of the Precautionary Principle wherein safety, rather than being a relative concept, becomes finite. And that’s just not possible. Perfection is an ideal to strive for, not a reality to wait on. If the FDA’s professional staff chooses to wait for perfection then new drugs will simply not come to market and the implications of that are just too profound to ignore. It’s time for an FDA BRAC process to begin. It’s time that Bureaucrats Realize Actions Count.
It is time to supersize Bill Lockyer’s brain because the California AG just keeps making the same basic mistake. He doesn’t understand that the FDA has jurisdiction over food safety. His latest attempt at playing Elliott Spitzer Jr. is to demand warning labels on potato chips and French fries (which, by the way, he admits “sure taste good”). Bill, lockyer self in a room and read the Nutrition Labeling and Education Act.
And be particularly cautious about those beachballs — especially in California.
Whose Vioxx is gored?
August 28, 2005
Litigators are circling like alligators around the quivering drug company Merck. Estimates of what Merck ultimately may have to pay people who used its pain pill, Vioxx, rise every day: $50 billion is the highest bid so far. Last week, in the first case to come to trial, a Texas jury awarded Carol Ernst $253 million over the death of her husband. She may get a mere tenth of that. But there are nearly 5,000 Vioxx lawsuits. Just type “Vioxx” into your favorite Internet search engine to see why that number may rise to 20,000.
Merck has set aside $675 million just to cover its legal expenses. But the lawyers collect from both sides. If Carol Ernst gets $25 million, about $8 million of that Ã¢ the traditional one-third Ã¢ will go to her lawyer, Mark Lanier. Lanier says that after he pays off the law firm that turned the case over to him, plus other expenses, he’ll be “lucky to get 10%.” Shucks.
You may be under the impression that Merck did something terribly wrong in putting Vioxx on the market. But the Vioxx cases don’t generally claim that.
Instead, they are based on the last refuge of the tort lawyer: the “duty to warn.” Any product carries some risk. If you slice up a beach ball, saute it and eat it, the consequences could be dire. But even the world’s greatest lawyer would hesitate to argue that this is the fault of the beach ball manufacturer. That doesn’t mean the lawyer won’t take your case. He or she will take it and argue that the manufacturer should have warned purchasers that beach balls are not edible, cooked or raw.
The duty to warn is one of the law’s great celebrations of hindsight. When something actually has gone wrong, it is hard to argue (especially to a jury) that this development is too unlikely to worry about. And it is nearly impossible to argue that consumers shouldn’t be given information to decide for themselves.
Speaking for myself, I set aside one day a month exclusively for reading all the warning labels on products I have bought, such as beach balls. Then I assess whether the risk I am undertaking exceeds the benefit I hope to gain. But I wonder how many of my fellow citizens are so scrupulous.
I wonder, in particular, how likely it is that Carol Ernst’s husband would even have noticed such a warning on the side of the box or bottle or speed-mumbled during one of those eerily atmospheric TV commercials for prescription drugs.
Or, if he noticed it, would he have acted? It might have saved his life, but only in the way that deciding to take a later flight has saved your life when the earlier plane crashes. There is no actual connection. The studies Merck is accused of ignoring suggest a small increased risk of a heart attack among people using Vioxx for more than 18 months. Robert Ernst had used Vioxx for only eight months, and he didn’t die of a heart attack. He died of a different heart ailment known as arrhythmia. Lanier persuaded the jury that the arrhythmia could have been caused by an earlier heart attack that left no trace.
The absurdities pile on. Everyone but a few extreme libertarians can agree that the government has a legitimate role to play in protecting us from dangerous prescription drugs. Only the government can make rules that are uniform and consistent over time, so that investors in drug research can rely on them.
But in our current system, the government plays two conflicting roles. The FDA approves or disapproves a new pharmaceutical, weighing the trade-off between risk and benefit. And then the court system comes along and sees that trade-off differently. The fact that Vioxx was approved by the FDA carries little authority in Tort World, where thousands of juries in hundreds of courts of the 50 states will draw the line in other places.
Vioxx was a nearly unnecessary product. It came on the market in 1999 as an expensive alternative painkiller for people whose stomachs couldn’t handle cheap pills such as ibuprofen. Merck’s real offense was selling Vioxx to millions of people who didn’t need the stuff. It did so by abusing the power of advertising, the reality of insurance and our national penchant for shortcuts in the pursuit of happiness. But the entire pharmaceutical industry is guilty on those charges, which apply to safe drugs as well as dangerous ones.
Then there is justice. Foreigners look with amazement on a society that gives Carol Ernst $17 million or so in trade for her 59-year-old husband — more than he’s worth to anyone else and yet almost insultingly inadequate to her — and gives tens of millions to a few lawyers like Lanier, and is about to institute a transparently phony plan to provide prescription drugs that do work to people who need them, but with no money to pay for them.
From an interview with Janet Woodcock that will appear in the September 5 cover story of Business Week …
Q: What’s your vision of how drugs can be used in better, more targeted ways?
A: The overall vision is a medical vision: that we can get better outcomes for people and get a higher percentage of people who actually respond to any given treatment. Instead of your doctor telling you that 40% of the population responds to a drug, he can tell you that if you take this drug, you have a 90% chance of responding.
On the flip side, our vision is that there aren’t bad drugs or good drugs. Instead, some drugs run into bad problems with a small subset of people. Instead of taking all those drugs off the market or putting warnings all over them, we need to make sure that people who are at high risk for a side effect don’t get the drug in the first place.
The vision is that this will actually decrease the cost of health care. We know there is a tremendous burden from adverse events of drugs, and everyone agrees we can do a much better job.
Thanks Janet. Hopefully words presage deeds.
When asked how consumers can save money on their prescriptions (other than caveat emptor importation), I always point out that comparison-shopping between pharmacies can have a huge impact. So kudos to Cigna for their new web site that shows drug prices for 52,000 pharmacies nationwide (both brick-and-mortar and Internet). This site allows Cigna customers to compare the costs of both brand name and generics. (The prices vary based on the kind of insurance held.) The web site will also alert patients when drugs they are shopping for may interact with other medications they’re taking — not only saving out-of-pocket costs, but potential costly hospitalizations and other complications.
It’s been called the “Seen and the Unseen” by essayists. It’s referred to as “concentrated costs, diffuse benefits,” by economists. Others refer to it as “single-entry bookkeeping,” “focusing on the negative,” “telling only half the story.” In the drug debate, this often centers on pricing.
Brand name drugs cost more, decry the crusaders for price controls. They neglect to mention that the same competition also drives down generic prices to the lowest in the industrial world, as I pointed out in a recent post. But there’s plenty more than myopic focus on pharmaceutical costs misses.
In an example of excellent journalism, the Philadelphia Inquirer weighs in on the other half of the story on U.S. free market pricing of pharmaceuticals. No, it’s not about impoverished seniors, but how the industry’s massive investment in the Philadelphia region is providing jobs and pumping money into local school districts.
“You tend to go where you are welcome,” Pfizer’s CEO Henry McKinnell told the reporter. The story chronicles numerous Europe-based companies that are expanding in the United States, and we’re benefiting from our hospitality. The pharmaceutical industry employs 46,800 people in the Philadelphia region. It generates $5.8 million in taxes for one school district. “It’s pretty simple,” Montgomery County Planning Commission director Kenneth Hughes said of Merck, “They are growing and generating lots of jobs and tax revenue and prosperity.”
And where the research exists, the drugs will follow. U.S. labs generate 70 percent of new drugs worldwide. More important for Americans, these new drugs hit the pharmacy shelves here first. The story notes:
“From 1993 to 1997, Europe accounted for 81 unique new drugs versus 48 in the United States, according to the study by Bain, whose clients include pharmaceutical companies. But from 1998 to 2002 the trend was reversed, with 85 new drugs introduced in the United States compared with 48 in Europe.”
This is a piece to save for the next round of D.C.-based advocacy attacks on the pharmaceutical industry.
Scott Gottlieb is a lot of things. Public servant. Physician. Pundit. He is my former colleague at the FDA. Most importantly, he is my friend. And my blood boils with anger and frustration at today’s scurrilous attack on him in the Seattle Times (see below). Like the saying goes, everything you read in the newspaper is true — except for those things you know about personally. Scott I know personally. I know that he takes his work at the FDA seriously. I know that he takes his government oath to protect the public health seriously. I know that he is highly ethical and honest. And I know how much this article must hurt him personally. And, I’m sure, that is precisely why certain lupine elements are gleefully forwarding this ugly hit piece to their friends and colleagues. If people don’t agree with his policy positions they should dispute them, firmly, strongly, logically — and respectfully. That they have chosen character assassination only shows the weakness of their intellectual arguments — as well as their disappointing lack of character. For shame.
And you wonder why it’s hard to get the best people to work for the government!
Wall Street biotech insider gets No. 2 job at the FDA
By Alicia Mundy
Seattle Times Washington bureau
Only a month ago, Dr. Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors.
Now Gottlieb holds the No. 2 job at the Food and Drug Administration (FDA), the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted.
Wall Street likes the appointment of Gottlieb, 33, who believes in faster drug approval and fewer news-release warnings to the public about potential side effects of drugs.
But some medical experts are shocked by his July 29 appointment, coming at a time when the public is increasingly concerned about the safety of popular medicines. In addition, the federal government has just begun scrutinizing the growing financial ties between Wall Street firms and doctors researching new drugs.
Gottlieb’s new job “further impedes the independence of the FDA,” said Dr. Jerome Kassirer, former editor of The New England Journal of Medicine. “Gottlieb has an orientation which belies the goal of the FDA.”
“I’ve never heard of anything like this,” said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.
“If he’s had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It’s fundamental,” Goozner said.
Dr. Scott Gottlieb
FDA deputy commissioner for policy
Salary: About $140,000
1994: Bachelor’s degree in economics, Wesleyan University
1994-1995: Alex. Brown & Sons, investment bank
1995-1999: Mount Sinai Medical School, New York
1996-2001: Wrote for The Journal of the American Medical Association
1997-2005: Staff writer, British Medical Journal
2000-2002: Author, Gilder Biotech Report
2003-2005: Medical internist, Stamford (Conn.) Hospital
2003: Resident scholar on medical policy, American Enterprise Institute
March 2003-May 2004: Senior adviser, then director of medical-policy development, FDA
June-October 2004: Senior adviser, Centers for Medicare & Medicaid Services
Late 2004-July 2005: Resident scholar on FDA and Medicare policies, American Enterprise Institute
Late 2004-July 2005: Author, Forbes/Gottlieb Medical Technology Report
Late 2004-July 2005: Private consultant/speaker to investment firms and the pharmaceutical industry
Source: AEI and Dr. Scott Gottlieb
A half-dozen current or former officials at the FDA say they do not know of anyone from Wall Street moving directly into such a high-level job at the agency.
Until last month, Gottlieb was editor of a popular biotechnology investor newsletter, Forbes / Gottlieb Medical Technology Investor. Forbes touted Gottlieb’s stock-picking success on its Web site in mid-May:
“Special Offer: In the last few months, Dr. Scott Gottlieb recommended two cancer cure stocks to subscribers that have already climbed 38%. Click here for the latest report from Forbes / Gottlieb Medical Technology Investor, ‘Three Biotech Stocks To Buy Now.’ “
Now, as one of three deputy commissioners, Gottlieb will help oversee such major policies as the FDA’s fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry.
Gottlieb said he has cut his ties to Wall Street and discontinued his newsletter. He doesn’t see a conflict between that work and his new role as a high-ranking regulator.
“What I learned while working on Wall Street has informed almost everything that I have done since, but especially my work in the government,” he responded in an e-mail to questions from The Seattle Times. (The FDA would not allow the Times to interview Gottlieb or provide answers to questions about his background. The FDA has not released his financial-disclosure forms.)
“[It] has helped me appreciate where regulatory policy can be improved upon to help enable medical innovation and to turn scientific breakthroughs into practical medical solutions that can help patients.”
Gottlieb was an analyst for a Wall Street investment firm before going to Mt. Sinai School of Medicine in New York. He earned a medical degree in 1999, then did an internal-medicine residency. From 2003 until a few weeks ago, he saw patients during weekend shifts two or three times a month at Stamford Hospital in Stamford, Conn., he said.
Since becoming a physician, he has worn many hats. From 2000 to 2002, Gottlieb wrote the Gilder Biotech Report, an investment newsletter, reporting on potential FDA decisions, drug and biotech developments. He also worked as a staff writer for the British Medical Journal.
In 2003, he was a full-time resident scholar working on FDA policy issues at Washington, D.C.’s most formidable conservative think tank, the American Enterprise Institute (AEI).
Along the way, he became a leading proponent of doctors increasing their income by selling their understanding of drugs and the federal regulatory process to stock analysts and investment firms Ã¢ “Moving your Career from Main Street to Wall Street,” as Gottlieb wrote in an investment column in the American Medical Association newsletter.
He joined the Food and Drug Administration in March 2003 as a senior adviser on policy and soon made an impression. Later that year, the SG Cowen brokerage house sent a report to subscribers, “A Recap of What’s Gone Right at the FDA,” that praised Gottlieb and other new FDA officials under then-Commissioner Dr. Mark McClellan for working to streamline the drug-approval process.
“Should McClellan’s team succeed in getting their strategies adopted into the framework of the approval process, the team’s impact on FDA policy could last well beyond the current administration.”
Gottlieb moved with McClellan, brother of White House spokesman Scott McClellan, to the federal Centers for Medicare & Medicaid Services in June 2004 and left that October.
He then returned as a full-time scholar at the AEI and started the Forbes / Gottlieb Medical Technology Report.
Gottlieb, a Bush administration appointee making about $140,000, comes to the FDA with an agenda. In addition to advocating faster drug approvals, he has complained the FDA sends out too many “shotgun warnings” on any particular drug’s emerging side effects, which he said may cause patients to overreact.
He wants the warnings to be sent to doctors first, and without “overstating a product’s risk.”
He also has urged that the FDA change longstanding policy and release data on experimental drugs at different stages of the research, from animal tests to final patient studies.
Releasing more data at each stage would help investors put money behind promising drugs and products earlier and would better protect patients in the clinical trials, he has explained.
Three years ago, Gottlieb wrote about an issue that was spotlighted last month in a Seattle Times investigation Ã¢ the practice of doctors leaking details of ongoing drug research to investment firms, which can then profit from the information by selling or buying stocks.
The Times found 26 cases in which doctors leaked confidential and critical details of their ongoing drug research to Wall Street firms. The report has led to a Securities and Exchange Commission investigation.
“Traders will go to great lengths to get market signals from medical researchers,” Gottlieb wrote in Barron’s, an investor publication, “and the tight lid the FDA keeps on clinical-trials data has spawned a thriving niche of boutique investment-research firms that link money managers with medical experts capable of giving investors a wink and a nod.”
Gottlieb is against such leaks. But he did not call for better enforcement of confidentiality agreements that should preclude such behavior. He instead urged that the FDA open up its drug-approval process to investors and the public.
“Bizarre FDA rules allow companies to hide clinical information practically in perpetuity. Something needs to change,” he wrote in the Gilder Biotech newsletter in 2002.
“The FDA could and should release data contained in a company’s (FDA) filings at each stage in the process. … Why shouldn’t markets know what bureaucrats and insiders do?”
Kassirer, the former editor of The New England Journal of Medicine, said early release of clinical-trial information “strikes me as potentially good for investors but bad for the validity of clinical research.”
“Releasing data early could result in premature and erroneous conclusions about the drug or device being tested, premature ending of clinical trials and even inappropriate enrollment of patients,” he said.
The FDA would not comment on Gottlieb’s ideas on changing policy to allow for earlier release of clinical trial information, except to note that the articles were written before Gottlieb joined the agency.
He also has consulted for, and written positively about, a major matchmaking firm that links doctors with Wall Street investors, the Gerson Lehrman Group in New York.
He has known founder Mark Gerson for several years, and both are part of the conservative establishment in D.C. With his pro-market views “Scott is popular with some people at the White House,” said Robert Goldberg of the Manhattan Institute, a conservative think tank. He is a friend of both men.
Gottlieb highlighted Gerson’s firm in investment columns he wrote for the AMA newsletter, and encouraged doctors to join Gerson’s network and others. Not only can doctors increase their income, but they can help Wall Street investors decide which new technologies to put their money behind, he wrote.
Gottlieb said by e-mail that he was not paid to recruit physicians for Gerson’s group. He added he had recommended a handful of policy-makers to Gerson Lehrman and was paid for probably fewer than eight hours of work.
Gottlieb said he also did a little work for the SG Cowen brokerage house but has not taken part in any conference calls between drug researchers and investors discussing ongoing clinical research.
When the FDA announced Gottlieb’s hiring last month, it noted Gottlieb had been a practicing physician, a scholar at AEI and correspondent for the British Medical Journal. The agency did not mention Gottlieb’s stints as editor of the two popular biotech investment newsletters or his work with Wall Street firms.
Alicia Mundy: 202-662-7457 or email@example.com
In the movie “Marathon Man,” Lawrence Olivier’s Mengele-inspired dentist threateningly asks, “Is it safe?” That same question, under post-Vioxx fear, apprehension and recriminations, has the real threat of crippling open and honest scientific exchange at some high profile FDA advisory committees in September. Worse is the possibility that today’s bilious environment will keep new treatments from waiting patients. Worse still is the risk that such a Precautionary Principle-driven climate will drive the pharmaceutical industry away from important new therapies towards only the safest, least innovative R&D projects. These are frightening thoughts — and attention must be paid lest we find ourselves, micron-by-micron, abdicating the hope of 21st century medicine to politically expedient measures that serve only to further the political aspirations of sound-bite hungry politicians and the voracious appetites of trial lawyers.
Last week the New York State Pharmacy and Therapeutics
Committee met to discuss adopting an evidence-based medicine approach to state reimbursement practices. Except that’s not what the proponents of the measure really want. What they really want is to ration health care in New York State. Evidence-based medicine, according to the definition, is “The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine requires the integration of individual clinical expertise with the best available external clinical evidence from systematic research and a patient’s unique values and circumstances.” Sounds good, right? Wrong. Because what was being presented in Albany was what’s known as “Rational Use of Drugs,” better known as “rationing of drugs.” It’s the same drivel that the eurocrats in Brussels and Geneva have been trying to sell for years to an EU citizenry sick and tired of long waits and poor outcomes. As David Sackett wrote in a 1996 article in the British Medical Journal, “Doctors practicing evidence-based medicine will identify and apply the most efficacious interventions to maximize the quality and quantity of life for individual patients; this may raise rather than lower the cost of their care.” As a particularly pithy bit of testimony at the recent hearing put it, “The people of New York, especially vulnerable Medicaid patients, should not become unwitting subjects in this experiment, especially absent their informed consent.” Amen.