Lynched in absentia

• 05.04.2010

“Cowardice asks: Is it safe?  Expediency asks: Is it politic?  But Conscience asks:  Is it right?”

William Punshon

Strongly recommend that you read “Lynched in absentia” from this week’s edition of BioCentury.Here’s sampler – and it should leave a bitter taste in your mouth.

Based on her performance at last week’s hearing on the safety of Avandia rosiglitazone, Rep. Rosa DeLauro (D-Conn.) would have been quite comfortable in Brezhnev’s Russia, a time and place where political science trumped objective science and public inquisitions were pre-scripted to produce politically correct results.

The focus was allegations that GlaxoSmithKline plc had suppressed evidence about the dangers of its diabetes drug Avandia, and that top FDA officials were too biased by “cozy” relationships with industry or blinded by intellectual myopia to take obvious actions that would have saved thousands of lives. When BioCentury asked DeLauro after the hearing why she hadn’t solicited testimony from GlaxoSmithKline, FDA, or a diabetes expert, she replied that “they probably wouldn’t have wanted to come.” DeLauro, whose subcommittee sets FDA’s budget, noted that the company and agency are engaged in discussions over Avandia, and said she “didn’t want to put them on the spot. When did members of Congress become so solicitous of the feelings of corporate executives they accuse of intentionally killing their customers, or of government officials? Senior management from Goldman Sachs who sweated under the cameras for seven hours at a Senate hearing last week would have appreciated such courtesy.

In fact, GSK spokesperson Bernadette King told BioCentury the company learned of the hearing only a day in advance and “would have welcomed an invitation” to testify. DeLauro also told BioCentury there was no need for other witnesses because she’d invited two “independent experts” — Sidney Wolfe, director of the Health Research Group at Public Citizen, and Harlan Krumholz, professor of medicine and epidemiology and public health at Yale University School of Medicine.

Wolfe may be independent, but he certainly isn’t objective. In over two decades on the job, he’s prided himself on vigorously attacking the pharmaceutical industry and FDA. Krumholtz, a prominent and highly credentialed academic cardiologist, served as an expert witness in litigation against Merck and Co. Inc. over its Vioxx rofecoxib. But he’s not a diabetes expert, nor does he represent the thinking of most cardiologists: he has published comments on Avandia dissenting from a joint American Heart Association and American College of Cardiology Foundation science advisory that concluded the evidence for potential harm from Avandia is “inconclusive.”

DeLauro wasn’t shy about criticizing the agency in its absence, saying that whenever difficult drug safety issues come up it “always appear[s] to act on behalf of the industry.” FDA’s “notion is let us leave this [sic] go on for another several years while people die,” she said. DeLauro and Wolfe repeatedly pointed out that FDA’s John Jenkins had signed the original approval documents for Avandia in 1999 and is now in charge of its oversight, and asserted this somehow demonstrates systemic bias at FDA.

They didn’t note that in 1999 Jenkins was director of the Office of Drug Evaluation II, a position that gave him ultimate sign-off authority on approvals of new molecular entities. Nor did they note that Avandia decisions have been bumped up to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).

Wolfe did attack Woodcock, who like Jenkins was not present. The consumer activist said he’s “had many conversations talking with Dr. Woodcock about [drug safety] and she’s just uncomfortable being a regulator,” a charge that would be news to the companies that complain bitterly about FDA’s regulatory actions.

Wolfe, who has called for Woodcock’s dismissal, added that “being uncomfortable being a regulator is incompatible with being the head of the center.”

Wolfe supported this assertion by noting that Saudi Arabia — not usually on the list of the most advanced drug regulators — has banned Avandia. “FDA has more employees [working on] drugs than the rest of the world combined,” but less sophisticated regulatory agencies “are more attuned to public health than the FDA,” he charged.Wolfe conveniently failed to note that the European Medicines Agency has looked at the evidence and decided Avandia can remain on the market.

Star Chamber proceedings featuring half-baked reform ideas and populist attacks on regulators are wrong-headed and ethically challenged. In a better political world, FDA would ignore them.

“Conscience and cowardice are really the same thing.  Conscience is the trade-name of the firm.”

Oscar Wilde

The complete BioCentury commentary can be found here.

Maggie Backtracks on Provenge, Sort Of

• 05.03.2010

Maggie Mahar got beaten up so badly because of her mindless, anti-Provenge stance that she posted this on her blog May 1:

May 01, 2010

The American Cancer Society’s Dr. Len Lichtenfield on Provenge & Prostate Cancer:

Of course, all progress against cancer is in small steps.  But you wouldn't know that from any of her previous posts which consist of one big thumbs down (or another finger) in the face of cancer patients....

True Grid

• 05.03.2010

According to the Pink Sheet, “FDA is designing a five-item grid as a management tool to explain its risk-benefit decisions in a new more concise format. The model that it has created as a working template confirms a truism about its drug approval tendencies that industry has suspected for years: the baseline for FDA approval is a high rating of the severity of the disease being treated and the medical need for the product.”

The agency is developing a grid of the five basic factors that need to be addressed in any decision on the commercial availability of a drug. The top two are the seriousness of  the condition addressed and the need for a new treatment of the condition. Then comes the traditional heart of the NDA package: analyses of clinical data on the benefits of the drug and the risks associated with its use.

Significantly, the fifth fundamental factor is explicitly the level of risk management associated with the product. FDA is going to take it into consideration in every decision; sponsors who ignore or underplay the identification of who should use the product and who might use it will have a gap in their filings.

The grid proposal does not call for a fixed mathematical formula behind each approval. The agency has not tried to reduce the judgments in an approval decision to a rigid calculation.

Judgment?  You mean FDA decisions aren’t black and white?  Egad! Someone had better tell Rosa DeLauro.

In the words of John Jenkins, disagreement "happens a lot in the decisions that we have to make. Very few of the decisions that we make on drugs are easy. Very few of the drugs we see have a dramatic overwhelming benefit with relatively no risk. We see that most drugs have marginal to moderate benefits on a population basis and they have general safety but they have the risks of serious toxicities at some low levels." In other words, every decision is "very complex."

Key take-away is that the FDA is officially moving risk management (REMS anyone?) into the list of key factors affecting new products. And, for better or worse, "judgment" is in the eye of the beholder.

Maggie Mahar Hates New Cancer Drugs

• 04.30.2010

Provenge, the immunotherapeutic vaccine for patients with advanced (terminal) prostate cancer was finally approved.  Maggie (Too Many Cancer Drugs)  Mahar is not happy.  Here's why:  they are made by for-profit companies who can manipulate the FDA in order to market worthless drugs with serious side effects anytime they want.  According to her, making drugs is the easier thing in the world, especially cancer drugs.  Let's go back in time to one of her more lucid postings:

http://www.healthbeatblog.org/2008/02/the-wall-street.html

February 21, 2008

The Wall Street Journal Is Wrong on Avastin

......But focusing only on progression-free survival, i.e. how long a patient can go without a disease getting worse, is no better. As The Moss Report, an online cancer newsletter, notes, progression-free survival means that “a drug may change the shape of the patients' survival curve, but not alter the ultimate outcome. Treated patients may die on average at the same time as those who were not treated; sometimes they may even die sooner.”

In this case, we know that, any additional time comes with significant side-effects. In other words, the FDA’s stance is not just a question of time, but of quality.

Indeed, progression-free survival has the potential to be more devastating than standard deterioration. Imagine if, after two months of cancer stabilization, your loved one died at the same time as another patient who had been in worse shape for longer—that would be quite a blow.

The Moss Report points out that “patients who believe their disease is being controlled can feel an even greater sense of loss and disappointment when the disease again progresses than do those without any illusions about being cured of the disease.” Often abruptly dashed hope is more painful than a longer process, because the latter gives us time to prepare and come to grips with loss. If the Journal really wanted to think holistically about survival and benefits, it would be arguing against FDA approval of Avastin—not for it.

Yet the paper says that the FDA’s reluctance is symptomatic of an obstructionist “bureaucratic culture” bulwarked by “political pressure from Congress, where Members know they can always get headlines by calling for a crackdown on Big Pharma or exploiting public safety anxieties.” This isn’t fair. If we really want to make sure we maximize the benefits of medical science, we need to think hard about the incentives of drug companies—not just those of public officials.

The basic logic of the pharmaceutical industry is as follows: (1) a manufacturer creates a drug and runs trials, showing that it confers some benefit, either large or small. (2) The drug is approved by the FDA for a given use, and eventually for a wider array of conditions so that (3) use of the drug can proliferate across patient populations—thus allowing market share to grow. This leads to (4) increased profit, which leads to (5) nice, shiny Porsches.

These steps—or at least, one through four—make up the fundamental business model of prescription drug companies. All the cost is concentrated in steps one and two—research, development, and haggling with the FDA to get to market. To maximize profit, drug companies want to cut these costs as much as possible.

Now, if the FDA concedes that progression-free survival is enough to warrant approval, it essentially sets the bar very low for these early stages. The message is that manufacturers should go for the low-hanging fruit and focus on maximizing the number of ways to apply existing medications—rather than developing truly innovative new ones. The standard of proof is lower—so why not try and push through existing products, rather than incurring the costs of ground-up development?

No business in its right mind would say “no” to this opportunity. Already, drug companies spend more on promotion than on R & D because the effort is less and the financial reward is at least as promising—if not more so—than that attached to development. "

Of course, because it is so easy to develop cancer drugs.  I am sure Maggie is already planning her foray into the field.  After all, with the bar so low, how could she not...

Speaking of low bars... Why did Provenge developer Dendreon and prostate cancer patients had to wait another 3 years for the FDA to approve the product?

And why do most  developers of cancer drugs lose money?  And as for companies spending more on "promotion" than on R&D, it is a tribute to Mahar's ability to even get the small things wrong:  Drug companies spend 20 percent of their sales on R&D and, according to the CBO, devote 10 percent to promotion.   Last time I checked that's less.  

In any event, here's her 'reasoning' for being against drugs like Provenge and Avastin:

"Are you comfortable with the idea that the extra few months would be available to the wealthy, but not to the rest of us?

Also, if the patient has to pay for the very expensive drug that provides only a minimal benefit, there will be too few customers for the drug, and probably the drug company would stop
manufacturing it.

The only way that drugs like this stay on the market is if taxpayers (who pay more than half of all health care bills) continue to pay extremely high prices for drugs that provide a very small benefit."

On the one hand she writes -- in the very same post -- No business in its right mind would say “no” to this opportunity. Already, drug companies spend more on promotion than on R & D because the effort is less and the financial reward is at least as promising—if not more so—than that attached to development. "

But on the other hand, since the drug really doesn't work -- except for a few --  the company will stop producing it, except if the government also covers the medicine for people who are less well off? 

Should new drugs not be made available because they are expensive and only benefit a few people?  Is she against every orphan drug?

And here are Maggie's warm wishes for those now able to finally access Provenge

The Devil is in the Details, by George!

• 04.30.2010

Jeff George, the head of Sandoz (not the former NFL quarterback), predicts using existing regulatory pathways (like 505(b)(2) or a BLA) to bring FOBs to market rather than use the new regulatory pathway provided in the health care reform legislation.  Why? Because provisions in the new pathway that favor the innovator brands.

According to the Pink Sheet, “Generic drug makers applaud passage of the legislation, but some including Sandoz, are under-whelmed by the opportunity the legislation provides.”

Mr. George: "The devil's really in the details." He focuses on three issues:

(1) The provision for an FOB manufacturer to give its application to the innovator company to facilitate patent infringement negotiations. The health care reform legislation requires that biosimilar applicants provide the reference product sponsor with a copy of the application and "other information that describes the process or processes used to manufacture the biological product" within 20 days after FDA accepts the application for review.

(2) The reference product sponsor is then expected to provide the biosimilar applicant with a list of patents for which it thinks it could claim patent infringement, and each company is expected to lay out its legal basis and ultimately negotiate and reach a resolution on which patents to litigate.

Mr. George:  "I think it is unfair to generic companies that we would be required to hand over our dossiers to our competitors years before the product comes to market in order that they could pick apart our arguments scientifically and on the patent front to leverage in their own litigation against us.”

(3) The legislation does not require litigation resolution, opening the door to years of patent litigation, even after FDA approves a biosimilar. "Effectively, it calls into question why you would use this pathway if you've got to hand over your scientific dossier to your competitor on the one hand and your competitor can tie you up in litigation," George said. "With that kind of pathway, it's not clear that companies like Sandoz and the leading generic (sic) companies in the world would use this pathway to go to market.”

Sometimes a taste of your own medicine is good for the soul. 

And, on an unrelated note, one word – Provenge.

Son of Steve

• 04.29.2010

It’s frustrating when Congressional subcommittees only seek advice from people who tell them what they want to hear.

Case in point, the testimony of Harlan Krumholz (of Yale) at yesterday’s House Appropriations subcommittee hearing – chaired by Rosa DeLauro.

Dr. Krumholz thinks that the FDA should have an "emergency response" plan to follow when new safety findings raise questions about whether a drug should remain on the market. According to Dr. Krumholz, "There should be clear protocols, processes …We should not be in 2010 saying we still don't have all the data. We don't have all the facts, and we're in the same place we were when this [the meta-analysis] came out."

Really? Didn’t the FDA summon an advisory committee?  And didn’t that advisory committee vote 22-1 in favor of keeping Avandia on the market?

But let’s not focus on the facts when rhetoric is so much more fun. Here’s what Representative DeLauro's had to say, “Whenever there is a question asked about the science surrounding a drug, FDA always appears "to act on behalf of the industry.”

That being said, the issue is -- Can the FDA "own" safety?

(The short answer is that it must -- and must work immediately with skill and diligence to achieve that goal.)

At present, politicians and pundits (not to mention trial lawyers) own safety. They're the ones talking about it. They're who the media goes to when they write about it.  

And what about the role of industry, the other group being flayed with the safety knout? What have we heard from them on the issue of safety? Some, but not enough.

Americans woke up the morning after the Vioxx recall and were amazed to discover that drugs have risks. Good lord. Who let that happen! Avandia, in that respect, was Son of Vioxx. And, like any sequel, new actors were brought in to spice up the story.  In this respect Dr. Krumholz can be dubbed “Son of Steve.”

When it comes to patient trust, it shouldn’t be a choice between politics and public health – but those battle lines are being drawn. Unfortunately complex systems make for bad media coverage, while simplistic, dramatic demagoguing makes for sexier headlines.

There’s an apt Japanese proverb that bears repeating – “Don’t fix the blame. Fix the problem.” Unfortunately, the recent FDA-bashing isn’t about making things better – it’s about making headlines.

It's time for the grown-ups to step forward and take charge of the debate on drug safety.

Amazing Grace (Marie)

• 04.29.2010

From today's edition of the Wall Street Journal and the pen of our pal Grace-Marie Turner.

States Face Their First ObamaCare Test

States have until tomorrow to let Washington know if they plan to participate in one of the first government programs to be launched under ObamaCare—new high-risk pools for the uninsured. The question states should be asking is: Why would we participate?

The high-risk program is essentially insurance for individuals who have pre-existing conditions and are expensive to insure. The new health law allocates $5 billion for insuring them until 2014 when enrollees would be transferred to new health-insurance exchanges. But Richard Foster, chief actuary of the Centers for Medicare and Medicaid Services, reported last week that the high-risk program will run out of money next year or in 2012. Therefore, if states sign up for the program, they'll end up shouldering the burden for about two years after it runs out of federal money.

This will be a heavy lift considering the other costs ObamaCare is foisting onto states, one of which is the expansion of Medicaid, a joint federal-state program originally designed to cover low-income Americans. Under ObamaCare, Medicaid will be expanded to cover 84 million people by 2019, up from about 50 million today, putting pressure on states' budgets.

Georgia, Nebraska and other states have already taken a pass. The federal government will likely set up these risk pools without their participation. In a letter to federal Health and Human Services Secretary Kathleen Sebelius, Georgia's insurance commissioner John W. Oxendine said he feared the high-risk pools would "ultimately become the financial responsibility of Georgians in the form of an unfunded mandate." Kansas, Ms. Sebelius's home state, among many others, is considering opting out as well.

In addition to the cost, states are worried about the strings attached to the program. In a conference call with state officials last week, HHS officials weren't able to answer specific questions about federal mandates that will be placed on participating states. That's discomforting because HHS will draft the program's rules only after states decide whether to sign up.

What states already know should give them pause. By law, premiums in the new pools can cost no more than insurance for people in a state's standard nongroup insurance market. Most existing state high-risk pools charge 125% to 200% of standard rates because patients in those pools are by definition more expensive to insure. The new health law says that the federal government will set what states must pay doctors and hospitals for patients in the pools, and that the pools must cover all pre-existing conditions from day one. Right now, most states allow some waiting periods before covering pre-existing conditions to control costs. Washington will also determine which medical benefits must be provided.

Georgia calculated that, under these provisions, the high-risk program would cost more than the $177 million the federal government is expected to allocate for its program.

But what's most disconcerting is that the program will likely disturb the careful balance that some 35 states have struck in setting up their own high-risk pools. The federal high-risk pools would operate alongside existing state pools. States will be required to maintain funding for their pools, even while the federal government signs up new uninsured people for its program. The federal program will have more generous benefits and lower premiums than most state-funded high-risk programs, even though state officials say people in the new federal program are likely to be less needy than those enrolled in existing state risk pools.

The White House says high-risk pools were a Republican idea. But GOP leaders called for allocating $25 billion over 10 years (instead of $5 billion over three-and-a-half years) and would have given states far greater latitude in setting the rules.

If more states opt not to join the federal program, Congress will have to acknowledge that there has been a public repudiation of the federal program. That could create pressure to give states what they want—block grants to increase their existing high-risk pools or, for states that don't have them, money to set up new ones. Deciding whether to sign up for the high-risk program is an important early test for states to tell Washington who is in charge.

Ms. Turner is president of the Galen Institute, a nonprofit research organization focused on patient-centered health reform.

Obamacare's Financial "Reforms"

• 04.28.2010

Talk about requiring those selling securites to put in more cash  and have increased capital reserves rather than" assets of clients and counterparties as a source of liquidity..."  

The federal government is sucking cash out of it's "clients and counterparties" --  state Medicaid programs, providers, etc. to pay for Obamacare leaving near term shortfalls in their wake.

For instance:

State officials told Kaiser Health News earlier this week that they have already negotiated many drug discounts that exceed 15.1 percent so they will lose that money under the new federal rules. Some said millions of dollars could be on the line for individual states, but federal officials said they have not estimated the cost to states.

State officials had hoped the federal government would interpret the law in a way that left their discounts untouched. But in a letter Thursday to state Medicaid officials, the federal Centers for Medicare and Medicaid Services explained, "The amount of the savings resulting from the increases in the rebate percentages … will be remitted to the Federal government."

Cindy Mann, the agency’s director for the Center for Medicaid and State Operations , confirmed in an interview that meant states that already received drugmaker rebates between 15.1 and 23.1 percent would no longer be able to keep that portion of their savings. States and the federal government would continue to share in savings for the portion of the rebates both below and above that range. Many states already have average rebates well above 23 percent.

Mann suggested that state officials could negotiate deeper discounts with drugmakers to try to "recapture that dollar."

http://www.kaiserhealthnews.org/Stories/2010/April/22/Medicaid-drug-rebates.aspx

In otherwords,  you are on your own. 

In turn, the federal government will use that cash to finance small business tax credits -- that evaporate in 6 years -- for insurance coverage that, because of the legislation -- was estimated by CBO be 13 percent higher.  So Obamacare is draining Medicaid to pay for tax credits to reduce the increased cost of healthcare insurance triggered by the bill:

"The credits are available in full to firms with 10 or fewer employees who offer an average wage of $25,000 or less. The credit is reduced for employers who have as many as 25 employees and average wages of up to $50,000 annually. Employers with more employees or higher average wages don't get the credit at all.

In addition, the credits are only available for six years, further complicating long-term efforts to help small businesses afford providing health insurance for their employees, said Amanda Austin, director of federal public policy for the NFIB, which opposed the Democrats’ health reform efforts and the new law.

The tax credit is emerging as a flashpoint in the ongoing debate about how the reform will affect costs and insurance affordability.

Austin, who spoke Monday at a U.S. Chamber of Commerce forum on what health reform may mean for businesses, said that although some small businesses’ efforts to provide their employees with coverage might be helped by the tax credit, businesses don't want to continue to return to Congress every few years to ask for the program to be extended.

"What we want is the market to drop its costs down long term," she said, adding that individual and small group markets for health insurance could see premiums increase by as much as 13 percent in the coming years. In the meantime, she and others are spending a lot of time waiting to see what the Department of Health and Human Services will do as the rulemaking process for the health law begins to gain momentum."

www.kaiserhealthnews.org/Stories/2010/April/27/small-businesses-health-tax-credit.aspx

Meanwhile, the Obama administration and HHS Secretary Sebilius are disavowing the estimates of Medicare actuary showing a financial meltdown of Obamacare in the decade ahead, with same estimates showing a collapse of healthcare service delivery in Medicaid -- where most people receiving "insurance coverage" will go... At the same time,  the bill provides incentives for people to wait until they are sick instead of obtaining coverage, driving costs up. As the report states: “existing providers resources and could lead to price increases, cost-shifting, and/or changes in providers’ willingness to treat patients with low-reimbursement health coverage.”

tinyurl.com/24pgepa

What did Goldman Sachs call the less than healthy assets it was trying to sell? Something about Obamacare's financing of healthcare has the same smell. 

The FDA's War on Salt

• 04.28.2010

A recent study measuring the impact of the NYC's mandatory requirement to post calorie counts  found that calories per transaction in a Starbuck fell by 6%. 

Six percent. 

As in eating 232 calories compared to 247.  Fifteen calories if my math is correct.

Morever,  the "impact the effect of calorie posting is actually to increase Starbucks revenue. "

That means either more people showing up or people visting more frequently.  Eating more perhaps.

I bring this up in the context of the FDA's war on salt, which comes on the heels of yet another less than rigorous report issued by the Institute of Medicine...

Earlier this week, the Institute of Medicine released a report  recommending enforceable sodium standards on the nation's food suppliers as a way to curb heart disease fatalities. The FDA claims to be examining practical means of implementation.    

Dr. Michael Alderman, a hypertension specialist at Albert Einstein College of Medicine, has been quoted lately in many papers covering the recently vamped-up war on salt. Alderman said a randomized clinical trail is needed to determine the effect of reducing sodium intake on the length and quality of life. At this point, he says, there’s no proof that it couldn’t be detrimental.  

 

“In careful studies of response to sodium reduction, most people have no change in blood pressure, while perhaps a quarter to a third have a significant fall," he said. "And, importantly, something like 10 percent have an equivalent rise in pressure.”

 

Further, he said, salt reduction can also increase resistance to insulin and other hormones, which can damage cardiovascular health. 

 

 “Thus,” he said, “the health effect of reducing sodium will be the net of these
conflicting effects.”

www.pizzamarketplace.com/article.php

Moreover, we don't exactly know what role salt plays in regulating food or calorie intake.

UC Davis nutrition professor Judith Stern and three colleagues last November published a study in the Clinical Journal of the American Society of Nephrology that questions that "scientific logic and feasibility" of limiting sodium consumption.

Stern, along with UC Davis adjunct professor David McCarron, reviewed data from a range of worldwide studies and examined neuroscience research and found that a body naturally regulates salt intake "within a narrowly defined physiological range."

Stern goes on to note: "If a 'normal' range of sodium intake exists that is consistent with the optimal function of established peripheral and central nervous system mechanisms, that fact should be the sole basis of national nutrition guidelines for dietary sodium intake," Stern's study said. "To attempt to use public policy to abrogate human physiology would be futile and possibly harmful to human health."

ICU

• 04.28.2010

During her April 22 presentation to the Food and Drug Law Institute's annual meeting, Woodcock was asked when FDA would translate its commitment to the idea of transparency into a greater number of concrete actions. "The answer, honestly, is I don't know," she said. "These things all take time and resources, dedication ... So I can't actually tell you."

FDA's transparency initiative has three components: providing information to the public via a website about what the agency does; deciding what types of information can be disclosed (for example about new safety issues or product applications), and being more transparent to industry about its processes.

Some stakeholders have called on the agency to take transparency into newer areas, such as releasing product application "complete response" letters.

Dealing with documents is not as simple as posting them on the FDA website, it appears. Woodcock said nearly all of them would require some redacting of proprietary or other sensitive information for legal protection. She said when the number of pages reaches into the billions, it is a massive workload.

Transparency – terrific.  But how do we want to FDA to spend its resources?

On a entirely different subject, this just in from the BBC:

Men whose love lives are falling short can try a new prescription pill to combat the problem.

The first drug made available in the UK for premature ejaculation, called Priligy, can reportedly triple the amount of time a man can last in bed. It works by altering levels of serotonin in the brain, which should give men more control over ejaculation.

Keep calm and carry on.

The complete Beeb story can be found here:  http://news.bbc.co.uk/2/hi/health/8646075.stm