Suit Alleges Pfizer Spun Unfavorable Drug Studies

Pfizer Inc. marketers urged the suppression of medical studies that reached unfavorable conclusions about the effectiveness of the company's big-selling drug Neurontin, according to internal Pfizer documents submitted in a lawsuit against the company.

In 2004, Pfizer's Warner-Lambert unit pleaded guilty to felony charges and pharmaceutical fraud that it promoted Neurontin for uses not approved by the Food and Drug Administration, including bipolar disorder and chronic nerve pain. The FDA originally approved the drug as an antiseizure treatment for epilepsy and in 2002 for one kind of pain related to shingles.

Pfizer paid $430 million to resolve the charges and reimburse state Medicaid programs for unapproved, or off-label, uses of Neurontin. Pfizer said it made sure there was no improper marketing after it purchased Warner-Lambert in 2000. Pfizer has booked about $12 billion in Neurontin sales since then and, though the drug is now subject to generic competition, it remains a strong seller.

Documents and emails released this week in the case in U.S. District Court in Boston suggest Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions. The case consolidates lawsuits by health insurers and consumers seeking refunds for their Neurontin expenditures, based on alleged civil fraud. Plaintiffs are seeking $4.9 billion.

In a statement, Pfizer said it was "committed to the communication of medically or scientifically significant results of all studies, regardless of outcome." The company pointed to examples where it published studies of Neurontin with negative outcomes.

According to documents in the Boston case, a European study done in the late 1990s by Warner-Lambert to measure Neurontin's use for diabetic nerve pain produced consternation at Pfizer after it failed to find a significant effect. "I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible," wrote Michael Rowbothan, then Neurontin's marketing team leader, in a 2000 email sent after Pfizer bought Warner-Lambert. He added that "it will be more important to how WE write up the study."

The study's scientific manager, Beate Roder, wrote in an email to employees after Pfizer agreed to buy Warner-Lambert that she had been instructed "that we should take care not to publish anything that damages Neurontin's marketing success." Neurontin has been widely prescribed for diabetic nerve pain, according to market researchers.

In 2002, Angela Crespo, then Neurontin's senior marketing manager, emailed an outside firm that was contracted to write up the study's results: "We are not interested at all in having this paper published because it is negative!!" Pfizer declined to make the three employees in the emails available for interviews.

The company's writeup of the study was subsequently rejected by two medical journals. Some of the reviewers for these journals said the company was putting too rosy a spin on the results, the court documents show. The paper was never published, although Pfizer later summarized some of the study's results in a broad review published in 2003 in an obscure medical journal, Clinical Therapeutics.

That review excluded another study that Pfizer conducted in Scandinavia, which examined Neurontin's effectiveness for post-operative nerve pain. The study found that Neurontin didn't work measurably better than a sugar pill, according to a Pfizer internal report. The study's finding has never been published, though the analysis was completed in 2003. Pfizer presented a summary of the study at a 2002 conference.

By declining to publish negative studies, "Pfizer created the illusion of Neurontin's efficacy in the scientific record" that encouraged doctors to use the drug even where it doesn't work, said Tom Greene, a Boston attorney heading the litigation. U.S. District Judge Patti Saris in Boston last year denied Mr. Greene's motion for class-action status; the plaintiffs are seeking a second try in her court this week.

"Ethically, one is compelled to publish results," said Kay Dickersin, a professor of epidemiology at Johns Hopkins University in Baltimore, who wrote a report for plaintiffs that was submitted in the case. Ms. Dickersin said her fee will be paid to Johns Hopkins to set up a fund to distribute Pfizer's documents.

Ms Dickersin said that in exchange for being experimented upon in trials, patients are told they are contributing to human knowledge. To withhold negative results from the public breaks that ethical obligation to such patients, she argued. Pfizer says it has committed to publish all medically significant results.

In 2004, Pfizer completed a five-year study of Neurontin on patients suffering from bipolar disorder in Spain. A 2004 internal Pfizer report summarized the finding: The study "did not show statistically differences between Gabapentin and Placebo." (Gabapentin is the generic name for Neurontin's chemical formula.)

But in 2006, a Spanish psychiatrist, Eduard Vieta, who has been a paid consultant to Pfizer, published a report on the same study in the Journal of Clinical Psychiatry along with a Pfizer employee, Katia Verger, and other scientists. Their report claimed a statistically significant benefit. One difference: Dr. Vieta modified the scale used to assess how severely patients exhibited the symptoms of bipolar disorder, also known as manic-depressive disorder. That change increased Neurontin's score in the study. The change wasn't disclosed in the journal. Making such a change after a study's parameters were set, especially without disclosing the change, is generally considered improper by scientists.

Dr. Vieta's article also said it included results from all patients the doctors in the study intended to treat, a principle known as "intention to treat." But in reality, Dr. Vieta's article excluded 16 patients who hadn't complied with the study protocol, such as by not taking all the pills they were given.

The two modifications had the effect of turning a failure into a success.

In an interview, Dr. Vieta, of the University of Barcelona, said the modifications to the formula were requested by the journal and were a more-conservative technique. "Nobody in Pfizer wrote the manuscript," he said. He said the company's 2004 report of the study "takes a broader interpretation of the intention-to-treat concept" but that it was appropriate to exclude some patients from the analysis.

Pfizer said that "an implication that Pfizer improperly influenced any aspect of the published Vieta study for commercial reasons is without basis," adding that the drug lost its patent protection and top-selling status in 2004.

By: Keith Winstein
Wall Street Journal; October 8, 2008

Medtronic's Ties to Spine Doctors Attract Scrutiny

Congress Investigates Payments to Consultants; Queries Also Cover Complications Linked to Unapproved Procedures

Congressional investigators are probing payments by Medtronic Inc. to spine doctors working as consultants on a widely used bone-graft product, which has been linked to life-threatening complications.

In separate letters, Sens. Herb Kohl and Charles Grassley have asked Medtronic for records relating to consulting contracts it has with physicians for its Infuse Bone Graft, used to fuse vertebrae together.

Senators have questioned why Medtronic hasn't made public the names of doctors who are being paid by the company.

Sen. Grassley, the ranking Republican on the Senate Finance Committee, also requested information on complications suffered by patients undergoing off-label, or unapproved, procedures using the Infuse product. Both senators questioned why Medtronic hasn't made public the names of doctors who are being paid by the company and the amounts paid to them, as other orthopedic-equipment makers have done under agreements with the government. Sen. Kohl, a Wisconsin Democrat, is the chairman of the Senate Special Committee on Aging.

Medtronic said it will respond to the questions from the senators. It said it has been "very supportive of industry-wide transparency" and has backed federal legislation requiring all medical-device companies to disclose payments to physicians.

The Wall Street Journal reported last month on complications associated with off-label use of the bone graft, including cases where it has caused dangerous swelling in the neck. Infuse is a manufactured version of a naturally-occurring protein that promotes bone growth. It is approved by the U.S. Food and Drug Administration for use in the lower back, but surgeons say it is used widely off-label in other parts of the spine.

Doctors with financial ties to Medtronic have been among those promoting the off-label use of Infuse, leading to possible pharmaceutical fraud. Former employees have alleged the company induced doctors to use Infuse and other spine products by sending them on lavish trips to resorts, paying them undeserved royalties, and handing out lucrative consulting contracts that required little work.

In their letters, Sen. Kohl said the allegations by former employees are "highly disturbing." Sen. Grassley called them "troubling."

The company said the issues brought up by former employees in lawsuits are "mere allegations of inappropriate business practices" and that they were "said to have occurred years ago."

More recently, Medtronic said it has "put more rigorous systems and processes into place to assure alignment with our standards, identify any break from standards and address behavior that is in violation."

The senators also asked for more information on a 2002 lawsuit filed by former Medtronic legal counsel Ami P. Kelley that has been largely sealed by a federal judge. The suit, which was reviewed by The Wall Street Journal, includes allegations Medtronic paid for doctors' entertainment at a Memphis strip club.

That lawsuit and a separate one with similar allegations led to a $40 million settlement agreement between Medtronic and the government covering Medtronic products under federal health-insurance programs. The settlement agreement is being challenged in court by former Medtronic travel manager Jacqueline Kay Poteet.

Ms. Poteet, in her appeal, says the $40 million settlement is too low. In a letter Wednesday to U.S. Attorney General Michael B. Mukasey, her lawyer charges that the government investigation of alleged wrongdoing at Medtronic has been marked by "irregular and questionable conduct" by Justice Department lawyers.

Ms. Poteet's attorney, Andrew R. Carr Jr., of Memphis, alleges in the letter that a lead government lawyer in the investigation, assistant U.S. attorney Robert McAuliffe, was taken off the case because the Justice Department learned he was married to Susan McAuliffe, a lawyer at the law firm hired by Medtronic to represent it in the federal probe. Mr. Carr said Mr. McAuliffe was removed from the matter after the $40 million settlement had been negotiated.

"Contrary to the implication in Mr. Carr's letter the settlement was reviewed and approved by the department and entered into with Medtronic after a new attorney had been assigned," said Charles Miller, a Justice Department spokesman. "Moreover, Mr. Carr was aware that Mr. McAuliffe had stopped working on the case. The department is confident that the settlement was appropriate and in the best interests of the public."

Mrs. McAuliffe declined to comment. Mr. McAuliffe couldn't immediately be reached for comment.

Mr. Carr also said that other government investigators told him they "were not permitted to conduct a standard and thorough investigation" of the case.

By: David Armstrong
Wall Street Journal; October 2, 2008

Abbott Settles Civil Case With Texas for $28 Million

The state attorney general in Texas has reached a $28 million civil settlement with Abbott Laboratories over charges leveled more than four years ago regarding alleged false reporting of drug prices.

According to a news release from Texas Attorney General Greg Abbott, the state will receive about $18 million in damages and $10 million in attorney fees and costs. Abbott Labs did not admit any wrongdoing in the deal.

"This settlement allows Abbott to avoid the further expense, burden and inconvenience of continuing to litigate this case," company spokesman Scott Stoffel said.

The case involved how drug makers report false drug prices that the Texas Medicaid program uses to estimate the cost Medicaid providers pay to get products from the companies.

"The taxpayer-funded program vastly overpays providers for their products" if companies report inflated prices, which was what happened in this case, according to the attorney general.

The attorney general's office has settled with other drug companies over this issue in the past, and has pending enforcement actions against several additional companies. An agreement with Hospira Inc. -- a big generic drug maker that spun off from Abbott in 2004 -- will govern that company's price-reporting practices in the future, according to the attorney general's release.

By: Jon Kamp
Wall Street Journal; September 11, 2008

Whistleblowers Are Left Dangling

Technicality Leads Labor Department To Dismiss Cases

The Department of Labor, charged with enforcing the federal law protecting pharmaceutical whistleblowers at publicly traded companies, has been dismissing complaints on the technicality that workers at corporate subsidiaries aren't covered.

The government has ruled in favor of whistleblower attorneys 17 times out of 1,273 complaints filed since 2002, according to department records. Another 841 cases have been dismissed. Many of the dismissals were made on the grounds that employees worked for a corporate subsidiary, says Richard Moberly, a University of Nebraska law professor. He studies issues involving workers who face retaliation from employers for reporting wrongdoing, and based his findings on department data. The rest of the cases are either pending, withdrawn or were settled.

Sen. Patrick Leahy, a Vermont Democrat who helped craft the whistleblower provision -- part of the Sarbanes-Oxley corporate governance act -- says the law was meant to cover workers in corporate subsidiaries. "Otherwise, a company that wants to do something shady, could just do it in their subsidiary," he said.

Sharon Worthy, a Labor Department spokeswoman, said the agency "believes that there is no legal basis for the argument that subsidiaries of covered corporations are automatically covered" under the Sarbanes-Oxley whistleblower provision. "The plain language of the statute only applies to publicly traded corporations," she said in a statement.

The agency declined to provide the exact number of cases dismissed because employees worked for a subsidiary. Ms Worthy said only 17 employees have won favorable findings because many cases are settled before adjudication. Records show 187 cases have been settled to date.

The dismissed cases include three whistleblower complaints against the German manufacturing conglomerate Siemens AG and two against London media giant WPP Group PLC. The Labor Department rejected all five cases because the employees worked for subsidiaries, agency records show. Both companies declined to comment.

Another pending case involves UBS AG, the Swiss bank. The plaintiff, Timothy Flynn, alleged that in June he was suspended from his job as a UBS financial adviser for cooperating with a Massachusetts investigation of the bank's sales of auction-rate securities. Mr. Flynn's attorney, Jason Archinaco, says the Labor Department has asked him to show that the UBS unit that employed his client is covered under the act.

UBS declined to comment.

The Sarbanes-Oxley act, passed by Congress in 2002 in response to the Enron Corp. and Worldcom Inc. scandals, included the first federal protection for corporate whistleblowers. Before, there was only a patchwork of state laws protecting them from retaliation. Under the act, remedies can include back pay, reinstatement and attorney's fees.

The Labor Department's division of Occupational Safety and Health Administration enforces the Medicare fraud whistleblowers' provision. It prohibits publicly-traded companies or "any other officer, employee, contractor, subcontractor, or agent of such company" from retaliating against employees who provide information or assist in investigations related to alleged fraud. According to Sen. Leahy, the provision was written to be "interpreted as broadly as possible."

In a pharmaceutical whistleblower case still pending at the Labor Department, Carri Johnson, a Minnesota woman, alleges she received a poor performance review and was fired from her job as a manager at Siemens Building Technologies Inc. in 2004 after reporting suspected fraud.

Financial figures for Siemens Building, based in Buffalo, Ill., are included in Siemens AG's consolidated financial statements, which describe the unit as one of the company's "operation groups."

In a Labor Department filing, Siemens Building argued that it wasn't covered under the whistleblower provision. In November, an administrative law judge at the department sided with the company. Ms. Johnson appealed to the Labor Department's administrative review board, where the case is pending.

Gregory Jacob, the agency's chief legal officer, has asked the review board to uphold the November decision, according to filings in the case. In a legal brief, he argued that Ms. Johnson had not shown that the two companies were "significantly interrelated" or that Siemens AG controls employment policies at Siemens Building. He also wrote that the Sarbanes-Oxley law does not "expressly" mention subsidiaries.

In the last two years, the Labor Department has dismissed two other Siemens whistleblower complaints because the plaintiffs worked at subsidiaries, according to agency filings. Nearly all of Siemens AG's approximately 400,000 employees work at its business groups, according to Siemens AG's 2007 SEC filings.

In the last year, department judges have dismissed two whistleblower complaints filed by employees at subsidiaries of WPP Group PLC, saying workers at its subsidiaries aren't protected by Sarbanes-Oxley. In its annual report, WPP describes its various companies as being "centrally integrated."

Joseph Burke, a former production director at Ogilvy & Mather, alleged that the WPP advertising unit decreased his job responsibilities and ultimately fired him in retaliation for his cooperation with a federal criminal investigation into his employer's billing practices. Mr. Burke had testified in a 2005 federal trial, which led to the sentencing of two former Ogilvy executives to prison for overbilling the government for an antidrug campaign.

According to Labor Department filings, Ogilvy denied that Mr. Burke's dismissal was related to his testimony and said he was part of a "reduction in force." A company executive testified that Mr. Burke was a "terrific worker," according to a summarized transcript of the hearing,

Ogilvy argued that Mr. Burke's complaint should be dismissed because the company isn't subject to the Sarbanes-Oxley whistleblower provision. In May, a Labor Department administrative law judge dismissed Mr. Burke's whistleblower complaint, saying he "has not established, by a preponderance of evidence, that he is an employee of a company covered under" the Sarbanes-Oxley whistleblower provision.

Under Sarbanes-Oxley, whistleblowers eventually can appeal Labor Department's rulings to federal circuit court. But they face "an uphill battle," says Mr. Moberly, the law professor.

By: Jennifer Levitz
Wall Street Journal; September 4, 2008

Two Charged in Medical-Care Billing Scam

A top hospital official and the operator of a homeless facility face federal Medicare fraud charges for their alleged involvement in an elaborate plan to recruit homeless individuals for unnecessary health-care treatment and then bill the government for it.

Federal Bureau of Investigation agents on Wednesday arrested Rudra Sabaratnam, chief executive of City of Angels hospital, and Estill Mitts, operator of a homeless assessment center in Los Angeles's downtown "Skid Row," for conspiring to persuade homeless people to act as patients in an attempt to fill beds, according to the U.S. attorney's office here.

"Individuals who saw a great deal of money were trying to line their pockets illegally with millions of dollars that were intended to go to the elderly and the sick," said U.S. Attorney Thomas P. O'Brien. Mr. O'Brien said the investigation was ongoing and he expects other defendants to be indicted in the near future.

Lawyers for Messrs. Sabaratnam and Mitts couldn't be reached for comment.

At the same time, Medicare fraud whistleblowers have filed civil charges against three Southern California hospitals where search warrants were served Wednesday as well as against their chief executive officers and other alleged co-schemers, including an ambulance company.

Lured by the promise of money -- about $30 -- homeless individuals checked into hospitals, where they often received unnecessary and even potentially harmful diagnoses or treatments, according to the civil complaint. One homeless patient was given a nitroglycerin patch, which dropped her blood pressure to such levels that her life was imperiled, said Los Angeles City Attorney Rocky Delgadillo. As a result, Medicare and Medi-Cal, a joint federal and state program, were billed for the false services and provided the hospitals with compensation.

Los Angeles's sizable homeless population has been the subject of controversy in recent years, as some hospitals have been charged with dumping their discharged patients onto the streets of Skid Row. A new city ordinance, believed to be the first of its kind in the nation, makes it a misdemeanor for health facilities to transport a patient to a place other than his or her residence without written consent.

This investigation began as a result of a videotape by Los Angeles Police Department officers who noticed an ambulance dropping off five homeless people in downtown Los Angeles. One of those homeless individuals later came forth to reveal information about the alleged recruitment scheme.

"This is a shameless exploitation of the homeless population," said Mr. Delgadillo. "Skid Row has served as a cloak of chaos. But we're peeling back the onion and sending the message to these charlatans that the city and our residents do care about those who are in the most vulnerable situation in L.A."

By: Amy Kaufman
Wall Street Journal; August 7, 2008

Eli Lilly Signs R&D Pact With Covance

In a move aimed at delivering new medicines to market more quickly and cheaply, Eli Lilly & Co. struck a $1.6 billion deal with drug-development service company Covance Inc., which will buy one of Lilly's research-and-development facilities for $50 million as part of the agreement.

Lilly hopes Covance's expertise in conducting drug trials will shave months off the Indianapolis drug maker's early-stage product-development timeline, which could help it make faster decisions about whether to kill a compound or prioritize its development. A "significant" portion of Lilly's pre-clinical safety testing work -- which involves animals, not humans -- will be done by Covance from now on, according to Andrew Dahlem, chief operating officer of Lilly's R&D division.

The companies, which have had a long-standing relationship, announced the agreement Wednesday. Lilly Chief Executive John Lechleiter said the new 10-year contract with Covance means the Princeton, N.J., company "will continue to work with us...in a process of reducing our cycle times, particularly early-stage cycle times, measurably."

The hand-off to Covance of a 600,000-square-foot R&D facility in Greenfield, Ind., which was operating at only about half its capacity, will allow Lilly to reduce its fixed costs as well.

In similar agreements also announced Wednesday, Lilly is also transferring U.S. clinical-trial monitoring work to Quintiles, a pharmaceutical-services company, and data management to i3, a clinical-research organization.

Contract research businesses such as Covance conduct many clinical trials and focus on improving efficiency at every step of the process. They can accelerate execution of early-stage testing by 20% to 30% -- or about two to four months -- and can speed enrollment in human clinical trials by 6-12 months, according to Chuck Farkas, head of consulting firm Bain & Co.'s North American Healthcare Practice, which has conducted extensive research on drug-development cycle times.

Lilly's decision to move beyond simply contracting with Covance "sets the stage" for other companies to do so as well, says Eric Coldwell, a health-care business analyst at Robert W. Baird & Co.

This deal and the growing amount of outsourcing in the industry may also indicate more broadly that major drug makers are scrutinizing their "large, disjointed and bureaucratic operations" and "rethinking what their internal infrastructure and expense structures look like," Mr. Coldwell says.

He adds that in the long run, it may mean that pharmaceutical companies become more focused on being "the financier that aggregates data and markets data" rather than the entity that internally develops drugs.

Drug makers have been trying desperately to develop innovative medicines at a time when many companies are facing looming patent expirations on blockbuster drugs and struggling with their drug pipelines. Another issue facing major drug companies is the pricing of their drugs. Many drug companies have been investigated for inflating average sales price in an illegal practice known false average sales price or drg false claims. Lilly experienced a setback in June when the Food and Drug Administration decided it needed three more months before making a decision about the company's blood thinner prasugrel, which Lilly is hoping will be a big seller.

About 600 Lilly employees will be affected by the Greenfield facility's sale, according to Mr. Lechleiter. Some will go to Covance to continue working on drug trials while others may take alternative positions at Lilly.

By: Shirley Wang
Wall Street Journal; August 7, 2008

Medicare Could Use More Support

The Journal's editors recently took words out of context in order to reinforce their predictable slant on health care -- government involvement is bad, private sector is good. In doing so they confused the overall performance of Medicare with the Bush administration's commitment to dismantle it.

My remarks were not a slight on Medicare. They were directed at an ideologically consumed administration that has spent the past eight years attempting to privatize Medicare by ensuring that providers, taxpayers and senior citizens become increasingly frustrated with the program. The reason is simple: this administration does not want Medicare to continue as a successful government health program.

The Bush administration would prefer to eliminate Medicare as an entitlement. It would turn Medicare over to for-profit health insurance plans, which, to say the least, have done a lackluster job at insuring anyone under age 65, and would surely increase Medicare fraud and pharmaceutical fraud.

Every bureaucracy has its faults, but Medicare provides an incredible benefit to Americans: ensuring that everyone over 65 has access to quality health care. Even if we doubled spending on administrative costs to ensure greater efficiency, no private plan would come close in choice, quality or cost. Medicare remains the most popular and efficient plan for taxpayers and senior citizens, the Bush administration's efforts not withstanding.

Wall Street Journal; August 28, 2008

A Drug Exec And a Congressman Spend $10 Billion

Three weeks ago The Wall Street Journal kicked off a debate on how best to allocate scarce resources to solve the world's problems. Bjorn Lomborg offered a summary of the latest findings from his Copenhagen Consensus project, where he has enlisted some of the world's top economists to address the issue. Now we're offering views on the subject from top political and business leaders. How would you spend $10 billion of American resources (either directly or through regulation) over the next four years to help improve the state of the world?

*Here we will feature the drug exec's article:

Teach Them How to Fish

In contemplating ways to spend $10 billion to realize the greatest gain for humanity, the key questions obviously are "Where?" and "How?" But allow me to suggest that our goal should be to create programs that are sustainable and to leverage the investment of billions of dollars into billions more -- regardless of the issue addressed.

Here's where I believe we can accomplish the greatest good: fighting infectious diseases that ravage the developing countries and increasingly threaten the developed ones.

Infectious diseases are the world's second-leading cause of death. Just three diseases -- malaria, tuberculosis and HIV/AIDS -- together kill nearly six million people a year, mostly in developing countries. This is roughly equivalent to the population of metropolitan Chicago. And, if these diseases are not properly treated, resistant strains emerge that threaten everyone regardless of where we live.

Columbia University professor Jeffrey Sachs makes a compelling case that disease devastates not only individuals and families. Societies and economies also suffer in lost potential and costs of care. That's why each dollar spent to ensure that people are healthier and more productive can yield a 20-fold benefit. *It's also vastly important that health insurances, if offered and used, are used properly. Pharmaceutical fraud can cause all sorts of problems for the average consumer. Many consumers who find themselves victims of pharmaceutical fraud turn to pharmaceutical whistle blower lawyers to help them receive the proper care and aid they deserve.

So, if infectious diseases are the targets, how should we invest our $10 billion?

I recommend we follow the wisdom of the Chinese proverb: "Give a man a fish and you feed him for a day. Teach a man to fish and you feed him for a lifetime."

I would invest half of the $10 billion in comprehensive treatment programs that could be sustained by the countries with high incidence of the above diseases, and which have leaders committed to long-term solutions.

I'd begin by ensuring that effective existing medicines are made available to the countries at low cost. Fortunately, many infectious diseases can be effectively treated with generic drugs -- which can be complemented by the antiretroviral and other critical medicines pharmaceutical companies are providing at deeply discounted prices.

In addition, to reinforce the programs' sustainability, I would transfer to local companies the technology and know-how so they themselves can manufacture the medicines that are already off-patent.

Medicines are effective only if they are used properly, however. So we must also take a comprehensive public-health approach and train doctors, nurses and ultimately patients to ensure short-term compliance with treatment regimes and, more broadly, slow the spread of disease. We should leverage existing organizations -- like the International Federation of Red Cross and Red Crescent Societies -- for this purpose.

I know this approach can work because for the past five years Lilly and 14 partners on five continents have been using it to combat a growing and virulent form of tuberculosis -- multidrug-resistant TB.

The progress we're starting to see -- in treating patients, improving manufacturing standards, and supporting local economies -- tells me such an approach could be adapted for an array of infectious diseases and supported by the countries most affected.

However, because the bugs that cause these diseases continually evolve and new strains emerge, any long-term solution requires another critical component: ongoing research.

I would use the remaining half of the $10 billion to foster investment in research, and I'd leverage it as I would the treatment programs -- by working to make it sustainable.

The problem is that there are no market incentives for research in infectious diseases of the developing world.

I would take the lessons learned from President Bush's BioShield experiments (which aimed to create an artificial market to attract biotech and pharmaceutical companies to develop medicines to counter a biological attack), and offer a guaranteed sum for whoever gets to a research-based solution first. This should attract competing programs and generate added investment by those pursuing novel treatments and cures for infectious diseases.

I believe the benefits from these proposals would expand like ripples across a pond -- bringing new energy and insights to the stubborn diseases that threaten all of us, and providing health and hope to millions of the world's neediest citizens who desperately need help now.

By: Sidney Taurel
August 18, 2008