Recent legislation in Texas that would permit the importation of foreign drugs has hit a couple of small snags — ability, legality, and safety. Problem 1: Ability. The Texas law calls for the importation of drugs from 10 Canadian pharmacies — except that Ujjal Dosanjh, Canada’s Minister of Health has introduced enabling legislation that will allow the Government of Canada to prohibit the bulk export of prescription drugs. Problem 2: Legality. It seems that the Texas legislators who introduced the legislation didn’t really believe that the illegal importation of foreign drugs was, well, illegal. A strongly worded letter from the FDA seems to have opened their eyes. Problem 3: Big safety problems. Rather than repeat the litany of reasons why safety concerns trump political posturing, suffice it to say that just because a politician says a drug is safe, doesn’t make it safe. Yes, everything’s big in Texas. And importing drugs from outside FDA jurisdiction would be a big (dare I say “Giant”) mistake.

I noticed a recent letter to the editor of The Hill from Congressman Anne M. Northup, arguing that the importation of drugs subject to foreign price controls would be consistent with both safety and patent protection. (Yes, Ms. Northup is a woman; “Congressman” is a title and not a description.) She is incorrect in both dimensions because she ignores the implications of foreign price controls on pharmaceuticals. As it would be very difficult to monitor the shipments, reverse shipments, cross shipments, and other machinations to which the legalized importation of drugs would give rise, pharmaceuticals purportedly imported from, say, Germany, in fact would carry a real risk of actual production almost anywhere. North Korea and Pakistan come to mind. And there is no need to speculate about this: The recent discovery of thousands of doses of counterfeit Lipitor in the UK is only the latest example of the fake drugs about which we know. Moreover, the foreign price controls are forced upon the pharmaceutical firms by governments threatening to confiscate patents; it is Orwellian, to say the least, for Northup and others to argue that only “patent-protected” drugs would be imported.

Northup and others argue that the importation of pharmaceuticals subject to price controls would be a manifestation of “free trade.” Please. That is analogous to an argument that the purchase of stolen merchandise from the back of a truck is “free enterprise.” It is the effort of foreign governments to use price controls to obtain free rides on the research and development costs borne by U.S. consumers that is the real problem; the importation of foreign price controls will merely reduce future cures in favor of present wealth transfers. Sadly, Northup is concerned above all with present voters.

Just saw this news item —

Statin drug may save lives of heart attack patients, according to a study of more than 170,000 patients. A study published in the American Journal of Cardiology shows that taking statin such as Pfizer Inc.’s Lipitor, the world’s best-selling prescription drug, within 24 hours of admission for a heart attack can markedly reduce the risk of early complications and of dying in the hospital.

“This is the largest study to look at whether very early use of statin therapy after (a heart attack) can influence clinical outcomes,” Dr. Gregg C. Fonarow, from the University of California Los Angeles, was quoted as saying by Reuters Health. The results do, in fact, “suggest that statins offer additional protective effects early.” The research led by Fonarow involved comparing records of more than 170,000 patients in the National Registry of Myocardial Infarction. The registry, coordinated by Genentech Inc., has collected data on more than 2.3 million heart-attack patients since 1990.

That’s certainly good news, but here’s the question — would statins be approved today under the current political environment? Unfortunately, that’s a debatable question. It’s worthwhile to remember that “back in the day,” Bob Temple saw the value of statins when the category was new and the data was spare. Temple saw the wisdom and lives were (and are) saved. FDA serves us best when it strives to both protect and advance America’s health. Imagine health care today minus statins. Imagine the dollars spent on hospitalizations. Imagine the lives lost. The wisdom of Temple is wonderful, but the FDA as Temple of Wisdom is essential. And science and politics don’t mix.

Business Week offers an insightful cover story on the promise of and impediments to smart drugs — products that target narrower subsets of a population depending on individual genetics and the specifics of the condition. The stories are fascinating reads, containing material familiar to industry insiders and hangers on but news to the public.

Embedded in the tale is the central role of profit-seeking companies, such as Switzerland’s Roche. The company bet against the best advice of its own scientific advisors and laid down $300 million in 1991 on a poker hand that indirectly led to the development of AmpliChip, a device that promises to pinpoint which drugs will help specific individuals. The stifling role of regulation is indirectly covered through a feature on FDA Deputy Commissioner Janet Woodcock, who recognizes and is addressing legitimate industry fears about narrow markets and overbroad regulation. “It isn’t that there are some bad drugs and some good drugs,” says Woodcock, in a quote that could be entered by the defense in any number of Merck’s Vioxx trials. “It’s that some drugs run into bad problems with a small subset of people.”

And, of course, unnamed naysayers and professional worriers appear, fretting that any progress may lead to increased spending on health care and life insurance denials.

“Not only is the field still immature but it is also beset with concerns about public policy and privacy. Experts fear individuals may be denied life insurance, health insurance, or even a job if they’re known to harbor genes for a debilitating illness. Also, there is a debate about whether personalized medicine will reduce or increase health-care spending. Better diagnostics would let doctors intervene more quickly, avoiding some costly procedures. But hospitals may also order more and more tests indiscriminately to cover themselves against possible lawsuits for not detecting diseases before it’s too late. And those tests can be expensive: A test for abnormalities on the BRCA1/2 genes implicated in certain breast and ovarian cancers costs $3,000 a piece.”

The possible lawsuits ought to be addressed with medical malpractice reform, not a halting of progress. As for the $3,000 price tag, ask yourself if this is too much to pay if the person in question was your husband or wife, partner, child, mom, or yourself? I’d take two just for safety, as would many others. The larger issue has to do with price controls. Although unstated, every promised advance detailed in this feature would disappear tomorrow if drugs were subject to price controls. That’s the real risk.

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.

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.

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.

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

Age: 33

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 â “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 â 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 amundy@seattletimes.com

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.

There is not a short supply of politicians who think they know better than the FDA when it comes to protecting the public health. The most recent is California Attorney General Bill Lockyer. Mr. Lockyer feels that the FDA’s warning about tuna and mercury isn’t strident enough (even though the tuna industry went ballistic when they were issued) — and he wants to take the matter into his own hands. He wants to require signs on store shelves or labels on tuna cans in California warning of the dangers of mercury. I guess he was not aware that labels on food are, by dint of the federal Nutrition Labeling and Education Act, under the suzerainty of the FDA. Fortunately the FDA was more than happy to remind him. In a recent letter, FDA Commissioner Crawford helpfully reminds Mr. Lockyer that, “California should not interfere with FDA’s carefully considered approach of advising consumers of both the benefits and possible risks of eating seafood.” Sometimes the same lesson has to be learned more than once. In 2004, when the state tried to add warnings onto nicotine patches, the California Supreme Court ruled that FDA-approved warning labels for the products precluded the state from requiring additional warnings. It’s sad that, in Prop 65 World, products like nicotine patches that help you quit smoking, and tuna that provides valuable health benefits — even to pregnant women — require more warnings but not more educational promotion — particularly from the Bully Pulpit of elected office. Plato’s “Allegory of the Cave” puts forth the proposition that the unenlightened cannot tell the difference between shadow reflections and reality. In California, the “Allegory of the Tuna” teaches us that only politicians can see the truth — and science be damned.